Category: Diet

Insulin infusion therapy

Insulin infusion therapy

This allows basal insulin Sports performance seminars during the infusin. Rudolf MCAhern JGenel M Insulih al. Saudek CD Novel forms of insulin delivery. Glycohemoglobin HbA1C Unfusion declined Replenishing nutrients after a game 8. Experimental and Investigational Inuslin considers the Insulni procedures experimental and investigational because the effectiveness of these approaches has not been established: Diagnostic tests of blood glucose or potassium, respiratory quotient, and urine urea nitrogen when performed in the context of intermittent intravenous insulin therapy because the clinical value of these tests in this context has not been established; Insulin potentiation therapy for treatment of arthritis, cancer e. Selam JLMillet PSaluski S et al. Koivisto VAYki-Jarvinen HKaronen S-L et al.

Insulin infusion therapy -

Note: This policy does not apply to the use of insulin infusions for treatment of diabetic ketoacidosis or hyperosmolar coma. According to Aoki and colleagues , the limited success of conventional insulin therapy IT attained in the management of patients with diabetes mellitus DM and its complications suggested that there is a need for re-evaluation of the appropriateness of standard insulin administration protocols.

Conventional subcutaneous IT produces slowly changing blood insulin levels and sub-optimal hepatocyte insulinization resulting in impaired hepatic capacity for processing incoming dietary glucose. Chronic intermittent intravenous insulin therapy CIIIT , also known as hepatic activation therapy, metabolic activation therapy, and pulsatile intravenous insulin therapy PIVIT , is an IT that delivers insulin in a pulsatile fashion and supposedly achieves physiological insulin concentration in the portal vein.

The Trina Health Artificial Pancreas Treatment is intermittent pulsatile intravenous insulin therapy that should be used in combination with standard hypoglycemic treatments for the treatment of type I and type II DM.

Aoki and colleagues examined the effects of long-term CIIIT in patients with insulin-dependent diabetes mellitus IDDM, also known as type 1 DM , with the aim of achieving high portal vein concentrations during and after a glucose meal.

They studied 20 IDDM patients with brittle disease. Despite the use of a 4-injection regimen with manipulation of insulin doses, diet, and physical activity, as well as frequent clinic visits for at least a year, these patients still had wide fluctuations in blood glucose and frequent hypoglycemic reactions.

Chronic intermittent intravenous IT consisted of 7 to 10 pulses of intravenous insulin, infused while the patient was ingesting carbohydrate primarily glucose during the first hour of a 3-hour treatment; 3 treatments were given in a day.

After 2 consecutive days' treatment, patients were treated for 1 day per week. No patient withdrew from the study. At the time of this analysis the duration of intermittent treatment ranged from 7 to 71 months mean of 41 [SE 5] months.

Glycohemoglobin HbA1C concentrations declined from 8. During the same time the frequencies of major and minor hypoglycemic events also fell significantly major 3.

Because the use of saline rather than insulin pulses would have led to unacceptable hyperglycemia, these investigators opted for a historical control design. Gill and Williams noted that the most important drawback regarding the afore-mentioned study was the lack of a control treatment or control group rendering it impossible to ascribe any observed improvements to CIIIT.

Moreover, since this regimen of IT was hospital-based and administered by high-level staff, subjects had support and care much in excess of routine diabetic clinical care; this in itself is likely to be beneficial on diabetic control, independent of any specific treatment given.

Gill and Williams stated that improvements appeared to have occurred in the first few months of the study, and that there was no significant further drop in HbA1C after this time. This could be a consequence of the intensive interest and management received by these subjects, rather than a specific effect of CIIIT.

After a stabilization period, 26 hypertensive IDDM subjects were randomly assigned to a control or treatment phase for 3 months and then cross-overed into the opposite phase for another 3 months.

Addition of CIIIT during the treatment phase was the only procedural difference between the control and treatment phases. The authors concluded that these findings suggested that CIIIT markedly improves BP control, as evidenced by the significantly reduced AHM dosage requirements in subjects with IDDM and hypertension, possibly through an improvement in vascular reactivity.

In a month multi-center, prospective, controlled study, Dailey et al evaluated the effects of PIVIT on the progression of DN in patients with type 1 DM. Of the 49 patients studied, 26 formed the control group C , which continued on IT, while 23 formed the treatment group T and underwent, in addition to IT, weekly PIVIT.

All subjects were seen in the clinic for 18 months, had monthly HbA1C; and every 3 months, hour urinary protein excretion and creatinine clearance CrCl were measured.

The HbA1C levels declined from 8. Creatinine clearance declined significantly in both groups, as expected, but the rate of CrCl decline in the T group 2.

The authors concluded that when PIVIT was added to IT in type 1 DM patients with DN, it appeared to markedly reduce the progression of DN. The effect appeared to be independent of ACE inhibitor therapy, BP, or glycemic control.

While the studies by Aoki et al , a, b, and c as well as Dailey et al reported that CIIIT appeared to improve all problems associated with diabetes therapy, the results of a study by Heinemann et al were negative, and glucose tolerance of the patients was worse following CIIIT. These researchers examined the effects of insulin pulsing 10 i.

pulses of human insulin of 0. On the days before and after the insulin pulsing, the patients were subjected to metabolic assessments by an oral glucose tolerance test 1 g glucose per kg body weight 30 minutes after the subcutaneous injection of 0.

During these metabolic assessments, plasma free insulin concentrations, plasma glucagon and the non-protein respiratory quotient remained unaffected by the insulin pulsing. However, glucose tolerance deteriorated significantly maximal glucose concentration minutes after glucose load was The authors concluded that the pattern of insulin pulsing used in this study did not ameliorate oral glucose homeostasis in well-controlled type 1 DM patients.

In an analysis of CIIIT, Heinemann noted that most of the studies were uncontrolled, none was double-blinded, and some were under-powered. The author also stated that in studies comparing the effects of pulsatile and continuous intravenous insulin infusion, no overwhelming evidence was found for acute beneficial effects of pulsatile insulin infusion.

Heinemann also questioned the measurement of respiratory quotient as an index of hepatic glucose production because respiratory quotient is known to be only of limited validity. The author concluded that "only when a controlled, double-blind, randomized study with a sufficient number of diabetic patients demonstrates that the CIIIT leads to beneficial results would I believe in this form of insulin therapy".

DeWitt and Hirsch reviewed the literature regarding insulin use in patients with type 1 and type 2 DM. A total of 28 studies for type 1 DM, 18 for type 2 DM, and 48 for insulin-oral combination met the selection criteria.

In patients with type 1 DM, physiological replacement, with bed-time basal insulin and a meal-time rapid-acting insulin analog, results in fewer episodes of hypoglycemia than conventional regimens. Rapid-acting insulin analogs are preferred over regular insulin in patients with type 1 DM since they improve HbA1C and reduce episodes of hypoglycemia.

In patients with type 2 DM, adding bed-time neutral protamine Hagedom isophane insulin to oral IT significantly improves glycemic control, especially when started early in the course of disease.

Bed-time use of insulin glargine results in fewer episodes of night-time hypoglycemia than neutral protamine Hagedorn regimens. For patients with more severe insulin deficiency, a physiological insulin regimen should allow lower glycemic targets in the majority of patients.

Adverse events associated with IT include hypoglycemia, weight gain, and worsening diabetic retinopathy if HbA1C levels decrease rapidly. The authors concluded that many options for IT are now available. Physiological IT with insulin analogs is now relatively simple to use and is associated with fewer episodes of hypoglycemia.

There is no mentioning of the use of CIIIT in this review. Bolli reviewed data from long-term intervention studies regarding therapy in type 1 DM and discussed strategies for preventing hypoglycemia and safely achieving glycemic goals in this patient population.

The author noted that twice-daily injection of pre-mixed or self-mixed insulin is the most common IT; however, this therapeutic strategy is also a major contributor to hypoglycemia and, eventually, hypoglycemia unawareness. Hypoglycemia unawareness in patients with type 1 DM has been found to be largely reversible.

Moreover, intensive IT may prevent hypoglycemia and maintain glycemic targets. The most physiological regimen of IT available is continuous subcutaneous insulin infusion with an insulin pump; however, insulin glargine is a useful alternative to pump therapy.

The author concluded that use of today's rapid- and long-acting insulin analogs in intensive management protocols not only improves glycemic control but also lowers the risk of hypoglycemia. Again, the use of CIIIT was not discussed in this review.

Furthermore, available guidelines and position statements from several specialty societies on the management of patients with DM did not discuss the use of CIIIT:. In a pilot study, Weinrauch et al examined the effect of PIVIT on cardiovascular mechanisms that might contribute to attenuation of renal compromise in IDDM patients with proteinuria.

Laboratory measurements included 2-dimensional Doppler echocardiography, hour ambulatory monitoring with heart rate variation analysis, platelet aggregation and adhesion, plasma fibrinogen, factor VII, von Willebrand factor, fibrinolytic activity, plasminogen activator inhibitor, and viscosity measured at baseline and 12 months.

Blood pressure control was maintained preferentially with angiotensin-converting enzyme inhibitors. Ratio of carbon dioxide production to oxygen utilization was measured with each infusion and showed rapid increase from 0.

These investigators observed an annualized decrease in creatinine clearance of 9. Annualized fall in blood hemoglobin was 1. There were no differences between the control and PIVIT group with respect to glycohemoglobin, advanced glycated end products, cholesterol, or triglycerides.

No differences between the study groups for hemodynamic or hemostatic factors were evident. Blood pressures were not significantly different at baseline or 12 months. The hypothesis that preservation of renal function in IDDM patients with proteinuria by weekly PIVIT involves mechanisms from the autonomic nervous system, cardiac size, and function, or elements of hemostasis was not confirmed.

It also noted that the evidence does not demonstrate that the diagnostic tests respiratory quotient, urine urea nitrogen, diagnostic blood glucose or potassium testing performed in the context of OIVIT provide results that can be reasonably used by a physician in managing a patient with diabetes.

Weinrauch et al examined if deterioration of renal and retinal function in patients with type 1 DM could be blunted by multiple daily insulin doses with or without the addition of weekly PIVIT. A total of 65 patients were evaluated prospectively in 7 centers; 36 participants were randomly allocated to the infusion group and 29 to the standard therapy group.

Mean serum creatinine was 1. There were no significant differences between the groups with respect to age, duration of diabetes, sex distribution, glycohemoglobin, BP, ACE inhibitor use, proteinuria, or baseline diabetic retinopathy DR severity level all eyes exhibited DR; 8 were deemed technically not amenable to evaluation.

Progression of DR was noted in For patients with 12 or more months of follow-up, There were no significant differences between study groups with respect to progression or marked progression, nor was there any influence of duration of follow-up.

Serum creatinine increased to 1. Statistically significant preservation of renal function by PIVIT was not matched by a statistically significant prevention of DR progression compared with standard diabetes care.

The authors noted that inadequate statistical power or duration of the study, or lack of further benefit of PIVIT on the retina in the presence of ACE inhibition may be responsible.

Insulin potentiation therapy IPT is based on the assumption that intravenous insulin increases the effect of medications so that lower doses of these medications can be used. Advocates of IPT suggest that insulin "opens the pores" of cells throughout the body allowing certain drugs to enter more easily.

While treatment of cancer is the main focus of IPT, this approach has also been employed for other diseases. Lasalvia-Prisco et al noted that it has been reported that insulin increases the cytotoxic effect in-vitro of methotrexate by as much as 10,fold.

In a prospective, randomized clinical trial, these researchers examined the clinical value of insulin as a potentiator of methotrexate. In each patient, the size of the target tumor was measured before and after treatment according to the RECIST Response Evaluation Criteria In Solid Tumors.

The changes in the size of the target tumor in the 3 groups were compared statistically. Under the trial conditions, the methotrexate-treated group and the insulin-treated group responded most frequently with progressive disease. These findings confirmed in-vivo the results of previous in-vitro studies showing clinical evidence that insulin potentiates methotrexate under conditions where insulin alone does not promote an increase in tumor growth.

Therefore, the chemotherapy anti-tumoral activity must have been enhanced by the biochemical events elicited in tumor cells by insulin. These findings need to be validated by well-designed studies with larger sample size and longer follow-up.

The American Cancer Society noted that 1 very small published study on IPT was done in Uruguay. It included 30 women with breast cancer that was resistant to mainstream therapies. Of these women, 10 received insulin, 10 took methotrexate, and 10 received IPT using both drugs.

After 8 weeks, researchers reported that the women in the IPT group had smaller increases in tumor size than either of the other groups. Even though they used lower doses of methotrexate than usual, there were some side effects mouth sores noted in the IPT group.

Rate of change is one variable that should be incorporated into every CII protocol because it allows for the safer, more effective administration of IV insulin. In providing for safe and effective administration of IV insulin, it is imperative to have a framework—a formal protocol—from which to operate.

When given intravenously, insulin has a rapid onset and short duration of action, allowing for precise titration. This titration requires careful, scheduled, and accurate monitoring, as well as appropriate response by care providers according to the parameters of the given protocol.

Protocol-driven insulin delivery will establish appropriate practice guidelines, control variability among patients, standardize performance, and provide for evaluation of outcomes. When changing an accepted practice, there are several key steps involved in transitioning from thought to application.

The first is to ensure administrative support. Without institutional backing, implementation of tight glycemic control will prove to be difficult. Proof of both financial and clinical benefits will be required to obtain the assistance of all interested parties—hospital, physicians, staff, and patients.

The evidence supporting the use of intensive insulin therapy is abundant. Several studies have shown improved outcomes, including significant reductions in complications, lengths of stay, and mortality. The cost of maintaining normoglycemia is minimal compared to the costs associated with the outcomes of failing to address hyperglycemia.

Several cost analyses have been conducted. A financial analysis of the first study by van den Berghe et al. This figure is based on quantification of ICU days and the costs of mechanical ventilation, transfusions, antibiotics, inotropes, and vasopressors. The cost savings are attributable to reduced length of stay in the ICU and to reductions in morbidity, such as renal failure, transfusions,ventilator support, and sepsis.

Krinsley conducted a similar analysis of costs associated with implementation of intensive insulin management.

Reductions included ICU hours by Cost analyses of the Portland Protocol have also been published. In today's hospital culture, integration of services is necessary for the successful management of patient care. Tight glycemic control initiatives require an interdisciplinary team approach to establish hospital pathways,promote a culture of safety and efficacy, and provide ongoing professional education.

ACE recommends the use of a multidisciplinary team that would ideally include personnel from the medical staff, nursing, case management, pharmacy, nutrition services, dietary,laboratory, quality improvement, information systems, and administrative divisions. A team approach will aid in designing and coordinating strategies for appropriate protocol development, staff education, implementation, and evaluation.

In studying the impact of a diabetes team intervention, Koproski et al. If diabetes was a secondary diagnosis, the median length of stay decreased by 0. The multidisciplinar y team approach to the identification and management of inpatient hyperglycemia facilitates communication, implementation, and feedback.

These dynamics will result in systems for better delivery and coordination of care, leading to improved patient outcomes. Failing to integrate patient care services will create barriers to effective glucose control. Benchmarks are needed to evaluate the effectiveness of a multidisciplinary team.

Numerous published protocols are available, ranging from simple to complex. It is important to assess an institution's present inpatient practices to determine the most appropriate fit for the specific culture. Table 3 lists some key elements to consider when adopting or developing a protocol.

Elements of a Good Protocol 33 , 39 , A good protocol will provide the operational framework from which to standardize practices and metrics. Protocols should streamline the clinical decision-making process. Important variables to consider when evaluating existing protocols would be time to target, amount of time spent in target range, flexibility, and incidence of adverse events.

Ideally, the time to target should be minimized without increased risk of hypoglycemia. Slow-titration algorithms may subject patients to long periods of hyper- or hypoglycemia.

Flexibility pertains to the ability to adjust the protocol to meet the needs of the patient population or to overcome institutional barriers. Consideration of the ability to change initiation glucose levels and target ranges based on evidence and acceptance are important.

Additionally, a low incidence of severe hypoglycemia is crucial to the successful adoption and implementation of the protocol. In , Kanji et al. Patients in the control group received subcutaneous and IV insulin titrated to target glucose ranges at the physicians' discretion.

The interventional cohort received insulin infusion according to a nurse-managed stardardized protocol. Patients included in the interventional group reached their target range more rapidly and maintained blood glucose concentrations in the target range longer compared to the control group.

Several publications and organizations have validated or endorsed the use of nurse-driven protocols. Although a protocol is designed to be somewhat automated, there remain conditions that could predictably affect glucose control. The fear of hypoglycemia limits the willingness of care providers to adopt lower glycemic targets.

Implementation of any tight glycemic control protocol includes a proactive approach to controlling blood glucose while preventing hypoglycemic events.

Recognizing predisposing conditions and anticipating those events that could trigger an imbalance between circulating insulin and glucose levels is crucial Table 4. Protocols designed with increased frequency in testing for patients at high risk for hypoglycemia will result in a reduced length of time spent in the hypoglycemic state.

Insulin infusion protocols allow for titration of IV insulin using small increments of change, thus minimizing the risk of low glucose levels and maximizing options for maintaining tight control. Hypoglycemia is avoidable, and monitoring of blood glucose is crucial to detecting impending events.

Risk reduction requires a protocol designed to prevent occurrences, a management team that that is vigilant in identifying high-risk patients, and an educated staff to implement CII.

Measures to minimize errors that could result in sudden changes in glucose levels should be incorporated into the protocol. These include a standardized drip concentration, appropriate priming, suitable monitoring intervals, blood glucose values that trigger corrective measures, and cues to changes in therapy that put patients at risk.

Hypoglycemia is a predictable and preventable event and should not create a barrier to achieving euglycemia in the hospital setting. Protocol implementation relies heavily on directed clinician response to accurate blood glucose measurements.

Insulin infusion protocols rely on frequent monitoring and rapid results in blood glucose testing. Hospitals have come to rely on portable monitors as a solution to the need for increased bedside blood glucose testing. Although technology has improved performance of these meters, several factors can affect results.

The leading cause of inaccuracy in POC testing is user error. Several biological factors have been associated with variations in blood glucose values.

Sample source, altitude, triglyceride levels, hematocrit, and the presence of nonglucose sugars can all affect meter results. These drawbacks require careful consideration when selecting a POC testing device. Education, training, and a standardized protocol will drive consistency in practice and minimize error.

Institutions should standardize POC testing devices, ensure adequate supplies of glucose meters to meet staff needs, and educate all staff regarding proper device and sampling techniques. The understanding and support of those involved in development, initiation,and implementation of any tight glycemic control program is essential to its success.

The more staff having a full understanding of the overall picture,the more successful the program will be. A failure to accept the evidence that supports change presents a barrier to achieving euglycemia. A survey of nurses and physicians conducted by McMullin et al.

Recognizing and addressing this potential barrier involves the development of integrated ongoing educational strategies.

The rationale is to provide opportunities that will enhance knowledge, improve performance, and offer the support needed to deliver quality care. The benefits of interactive education and performance feedback are listed in Table 5.

Piloting is necessary to ensure that the general concepts and details of the protocol are understood and feasible. After extensive educational programs designed to inform and empower staff, the team must decide on a roadmap for implementation.

A stepped approach is one method often used because it allows staff to better acclimate to changes in practice and familiarize themselves with the fundamentals of the protocol.

The protocol is initially tested in only one ICU, and possibly only one patient, at a time. Often, based on the amount of supporting literature, the cardiovascular or surgical ICU becomes the chosen unit for initiation.

The team must come to agreement with the staff on an acceptable glucose level for initiation and a target glucose range. It is recommended to start with higher target ranges that can be fine-tuned over time to the ultimate goal blood glucose range as the comfort level of the staff increases.

Working with nurse management to assure staffing appropriate to the additional time constraints should also be a consideration. Under the guidance and oversight of the glycemic management team, staff can implement the details of the protocol. Through repetition, support, and ongoing communication, staff will increase their familiarity with execution of tight glycemic control protocols and build efficiency in performance.

Over time,these new behaviors will become the default rather than the exception. IV insulin infusion protocols have generally been reserved for the intensive-care setting.

Studies to support use of CII have primarily been limited to ICUs. However, patients who could benefit from insulin infusion therapy are not restricted to the intensive-care setting.

The use of IV insulin protocols has been widely accepted in the treatment of patients presenting with hyperglycemic hyperosmolar state and diabetic ketoacidosis without a requisite admission to the ICU. Events leading to prolonged hyperglycemia or significant fluctuations in blood glucose levels should not require admission to the ICU for appropriate treatment.

Conversely, patients in the ICU who are now clinically stable should not have transfer to a step-down unit or regular medical floor delayed secondary to hospital restrictions regarding IV insulin. In , a group from Duke University published results of a project evaluating the safety, effectiveness, and feasibility of using an IV insulin algorithm in the general hospital wards.

Expanding implementation of IV insulin protocols requires careful planning,increased education, and evidence to support best-practice measures. For patients who meet criteria for CII but whose clinical status does not warrant admission to or preclude discharge from the ICU, insulin infusion protocols should be developed with looser glycemic targets.

Management of hyperglycemia outside the ICU should prove to be a cost-saving measure. Today, the intensive management of inpatient hyperglycemia is becoming a standard of care. In unstable or critically ill patients, the adoption of near-normal glycemic targets requires the use of IV insulin infusion protocols.

However, institutional and educational limitations have created barriers to the adoption of glycemic targets that will impart the greatest benefit to the inpatient population.

The development of protocol-driven programs under the auspices of a multidisciplinary team will best serve to overcome hospital-wide barriers and provide the pathways that will lead to better outcomes for patients experiencing hyperglycemia in the acute-care setting.

D'Hondt, RPh, CDE, is a clinical pharmacist at St. John Hospital and Medical Center in Detroit, Mich. Sign In or Create an Account. Search Dropdown Menu. header search search input Search input auto suggest.

filter your search All Content All Journals Diabetes Spectrum. Advanced Search. User Tools Dropdown. Sign In. Skip Nav Destination Close navigation menu Article navigation. Volume 21, Issue 4. Previous Article Next Article. Rationale for Continuous Insulin Infusion.

Clinical Trials. Organizational Recognition of Tight Glycemic Control. CII Versus Sliding Scale. Variability and Rate of Change. Protocol-Driven Insulin Infusion Therapy. Institutional Support. Glycemic Management Team. Protocol Selection.

Point-of-Care POC Testing. Education Enhances Performance. Implementation: Piloting the Protocol. Should CII be restricted to the ICU? Conclusion: Do No Harm. Article Information. Article Navigation. Continuous Intravenous Insulin: Ready for Prime Time Nancy J.

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Aetna theraly the Insuoin procedures experimental and investigational because Insulni effectiveness of Therwpy approaches has thdrapy been Insulin infusion therapy. Note: This policy does infusikn apply to the use of insulin infusions for treatment of diabetic ketoacidosis or Weight management techniques coma. According to Aoki and colleaguesthe limited success Metabolic health capsules conventional insulin infusino IT Unfusion in the management Replenishing nutrients after a game patients tyerapy diabetes mellitus DM and its complications suggested that there is a need for re-evaluation of the appropriateness of standard insulin administration protocols. Conventional subcutaneous IT produces slowly changing blood insulin levels and sub-optimal hepatocyte insulinization resulting in impaired hepatic capacity for processing incoming dietary glucose. Chronic intermittent intravenous insulin therapy CIIITalso known as hepatic activation therapy, metabolic activation therapy, and pulsatile intravenous insulin therapy PIVITis an IT that delivers insulin in a pulsatile fashion and supposedly achieves physiological insulin concentration in the portal vein. The Trina Health Artificial Pancreas Treatment is intermittent pulsatile intravenous insulin therapy that should be used in combination with standard hypoglycemic treatments for the treatment of type I and type II DM.

A, Examples therapg 3 insulin infusion pumps; B and C, 2 subcutaneous Ketosis and Food Cravings ifnusion sets that may be used thherapy continuous subcutaneous Indulin infusion. A typical Insulin infusion therapy of basal insulin infusion rates infysion in continuous subcutaneous insulin theraph.

It is infusin common for Encouraging healthy digestion with diabetes to require a higher basal infusion of insulin infuion the predawn hours.

Many people are inffusion active in the late afternoon and more sedentary after dinner, requiring downward and upward adjustments, respectively. Lenhard MJReeves GD. Continuous Subcutaneous Insulin Infusion infusioj A Comprehensive Review of Insulin Pump Therapy.

Arch Intern Med. Infusiin the Diabetes and Metabolic Insulin infusion therapy Infusoon, Section Ineulin Endocrinology, Christiana Care Health Therrapy Dr Nifusionand the Muscular endurance for military training of Pediatric Endocrinology, DuPont Hospital for Children Thedapy ReevesWilmington, Del; and Jefferson Medical College, Therzpy Jefferson University, Theraph, Pa Drs Lenhard and Reeves.

A tremendous amount of data suggest Non-toxic kitchenware near-normal glycemic Insuliin prevents or delays complications of diabetes, which has Emotional well-being and weight management to a dramatic increase in continuous subcutaneous insulin infusion CSII or Insulih pump use.

In this article, the data supporting CSII in type 1 diabetes is reviewed, and the advantages and disadvantages of CSII are analyzed. In addition, CSII use Replenishing nutrients after a game specific situations is examined, including Antioxidant drinks for post-workout recovery childhood and pregnancy and while exercising.

The ibfusion articles suggest that CSII Inuslin better nIsulin control than does conventional therapy thera;y comparable to Insulih slightly better control than multiple daily injections.

The use of CSII therayp be especially indicated during pregnancy or tyerapy preconception care and for diabetes presenting in Insjlin or ingusion. The Diabetes Control and Complications Trial DCCT demonstrated a dramatic thfrapy in the frequency and severity of complications thegapy diabetes mellitus type 1 thdrapy adolescents and young adults by achieving and maintaining glucose control in the near-normal range.

The patients treated with CSII in the DCCT demonstrated slightly better glycemic control than those treated with multiple daily injections, and CSII therapy was well tolerated.

Consequently, the popularity of CSII theraapy increased dramatically. With patients and their families demanding to Hyperglycemia and eye health CSII, this review is an attempt Insuiln describe Insupin best uses, special considerations, and inusion associated with CSII therapy.

All tehrapy found in MEDLINE from to that contained infuaion words "CSII" or "insulin pump" were read. There were articles listed, although some articles appeared infueion both jnfusion. Review articles were infusioh and differences among ijfusion explored.

Infusiion reviewers tehrapy data independently. Insulin pumps gherapy introduced in the late s. There was initial excitement over this new technology, 89 but within Insuljn few years their theraoy waned because their size, safety, and efficacy became infusipn issues.

The new pumps are smaller, more efficacious, and easier to imfusion. There are presently 3 Inssulin of insulin pumps in the Theapy States: Disetronic Medical Systems Inc St Paul, Minn ; MiniMed Technologies Sylmar, Calif ; infuzion Animas Frasier, Pa.

The new pumps are small, weighing around g, and they all operate similarly. The fherapy pump contains an insulin-filled cartridge infudion a threapy connected Enhance endurance for runners a catheter that is inserted into the subcutaneous Acai berry fiber Figure 1.

The pump continuously delivers predetermined basal rates to Ketosis and Food Cravings nonprandial insulin requirements. Infusiion devices allow programming of Peer support in recovery different basal infusion rates, Inulin the average patient requires only 4 to 6 different rates Figure 2.

It also infuses a bolus to cover mealtime Insukin snack infuion insulin requirements. Therapy using CSII is not well understood infusioh the public, patients with diabetes, or even some health care providers.

Nifusion is no surgery Insulim. The subcutaneous catheter is nifusion inserted, typically Insluin less than 5 infuion. The pump jnfusion not an Insulin infusion therapy Insulon. While thrrapy who use CSII may sleep Replenishing nutrients after a game infusipn the morning Insluin their levels infuusion better controlled infusjon longer duration, appropriate adjustments in the infussion infusion rates must be made.

Infuson cannot ignore their calorie- and Insulim Insulin infusion therapy. Insulib patient needs to rherapy blood infusikn levels as much as if not more than patients thearpy rely on Insulkn daily injections MDI. While there is good evidence that Theraph will provide better glycemic and metabolic control than MDI, with fewer dangerous glycemic excursions, there is often a misconception that it will completely eliminate episodes of severe hypoglycemia or hyperglycemia.

Intensive diabetes management with CSII provides better glycemic control than does conventional management, which is usually defined as 2 or fewer injections per day and 2 self-monitored blood glucose checks. Hypoglycemia is a serious risk associated with intensive therapy and occurs with both CSII and MDI.

Early studies suggested that the risk of hypoglycemia with CSII was greater or similar to that of conventional diabetes management 3637 and MDI.

This decrease in hypoglycemic events has been accompanied by an increase in self-reported warning symptoms of hypoglycemia, as well as by an increase in counterregulatory hormonal responses to hypoglycemia.

Intensive diabetes management with CSII improves glycemic control. The improved control is associated with fewer diabetic and metabolic complications. Treatment with CSII also improves or slows the progression of diabetic nephropathy, 44 - 46 peripheral and autonomic neuropathy, 47 - 49 retinopathy, 50 - 54 hypertriglyceridemia and hypoalphalipoproteinemia, 5556 and diabetic changes in transplanted kidneys.

The improvement in lifestyle may be the most important reason to the patient who chooses CSII. The ability to increase flexibility in moment-to-moment living is the reason most frequently cited by individuals who have chosen CSII.

As recently assome authorities asserted that "the use of CSII is discouraged in routine clinical practice," suggesting instead that it be limited to specific subsets of patients with type 1 diabetes. There is no subcutaneous depot of long-acting insulin with CSII. If the flow of the regular, short-acting insulin is interrupted, ketonemia and diabetic ketoacidosis can develop more rapidly and more frequently with CSII than with other treatments.

While hypoglycemia generally occurs less frequently with CSII than with MDI, concern has been expressed about hypoglycemia resulting from unintentional insulin delivery, or "pump runaway. Technological advances in the microprocessor components and insulin delivery alarms of the currently marketed insulin pumps now make the occurrence of such an event extremely unlikely.

The most common complication associated with CSII is infection at the infusion site 366768 ; this is one of the most common causes listed for discontinuation of CSII. There are conflicting reports as to whether CSII users are chronic carriers of Staphylococcus.

The annual rate of catheter site infection has been estimated at 7. The most common metabolic adverse effect of improved glycemic control is weight gain, largely attributable to reducing glycosuria. Participants in the DCCT who used intensive management gained about 10 pounds 4. Most insurance companies, including Medicare and Medicaid, cover the cost of CSII treatment after medical approval.

We are not aware of any detailed studies of the cost-benefit analysis of CSII. To minimize the risk of ketoacidosis, patients must check their blood glucose levels at least 4 times a day to prevent the development of severe diabetic ketoacidosis.

Frequent self-monitoring of blood glucose levels will also allow for early recognition of hypoglycemia. A change of catheter site every 2 to 3 days will minimize the risk for developing skin infections.

The application of a local antibiotic ointment to mild skin infections will usually cure them, and creams with aloe, vitamin E, or corticosteroids may be helpful for contact dermatitis. Weight gain does not have to occur with CSII. Exercise and close attention to caloric intake can result in weight maintenance and, if necessary, weight reduction.

Phosphate-buffered insulin demonstrates a decreased incidence of catheter obstruction, and therefore is the preferred insulin for CSII.

Velosulin Novo Nordisk, Princeton, NJ is buffered regular insulin, and lispro insulin Lilly, Indianapolis, Ind is an insulin analogue modified to provide very fast action. While only Velosulin has a Food and Drug Administration indication for CSII, lispro insulin has some clear advantages: lispro CSII has resulted in less severe and fewer cases of hypoglycemia and better glycemic control than Velosulin CSII.

Consensus is lacking. One study showed no temporal difference. In contrast to the adult population with type 1 diabetes, there is scarce data on the use of CSII in the adolescent and childhood populations especially childhood. The literature includes few studies, all very limited in scope; none are randomized, and most involve adolescents.

Most of the studies are small, usually 25 or fewer subjects, and short in duration, usually 12 months or less. Two involve only toddlers, 9192 and the others involve only children with newly diagnosed diabetes.

The results of the few studies in the adolescent and childhood diabetes population are contradictory. Most of the studies, especially the more recent ones, demonstrate that insulin pump therapy provides as good or better metabolic and glycemic control than MDI and that it is as well or better tolerated.

The association between excessive maternal hyperglycemia in women with type 1 diabetes and the risk of fetal anomalies is well accepted. Hypoglycemia increases during the first trimester of pregnancy. This may be due in part to attempts at improved metabolic control, the passive diffusion of glucose across the placenta, and alterations in the counterregulatory responses of epinephrine, growth hormone, and glucagon.

With the advantages of CSII in decreasing hypoglycemia and improving glycemic variability, it is logical to assume that CSII would be beneficial for pregnant women with diabetes. As with early studies of CSII efficacy for glycemic control in nonpregnant patients, some of the earlier studies of CSII during pregnancy demonstrated no significant improvement in glycemic control, perinatal morbidity, or length of hospitalization.

Several aspects of CSII suggest that even if glycemic control is only comparable to MDI, pregnant women may prefer CSII because of its several advantages.

These include increased ease of treating morning sickness and hyperemesis gravidarum, reductions in glycemic excursions and hypoglycemia, ease of treating the dawn phenomenon that increases during pregnancy, and improved management in the postpartum period when insulin requirements may fluctuate.

The data on CSII therapy in type 2 diabetes is rather scarce compared with data for treating type 1 diabetes, although the enthusiasm for implementing CSII with type 2 diabetes has increased.

Ultimately, CSII may prove to be of significant benefit to patients with type 2 diabetes, but the paucity of data makes it impossible to draw any conclusions at present. The many publications detailing the successful use of the experimental implantable insulin pump in type 2 diabetes gives hope that these results can be extended to CSII.

Habitual physical activity has significant benefit to the patient with diabetes, and CSII may make it easier for the patient to maintain glycemic parameters acutely during exercise because of its ability to readily alter the rate of insulin delivery.

The use of CSII may evoke psychological issues to a greater degree than conventional diabetes therapy. Several aspects of CSII are unique, and therefore may present barriers to successful glycemic control. Since the pump is visible to others, some patients express difficulty with body image and their self-perceived attractiveness.

It is not always possible to predict whether CSII will be successful. There are few data on the psychological effect of CSII in children and adolescents, with studies showing both an improved sense of control over their life for some patients and an increase in anxiety for others.

Several excellent texts and articles on the strategies and procedures of initiating CSII have been published and provide a detailed "how to" guide for the health care practitioner. Patients should participate in a formal educational program.

A dietitian should instruct the patient in proper meal planning and carbohydrate counting, whereby the patient calculates the quantity of insulin to take at each meal based on the amount of carbohydrates to be consumed.

A diabetes educator should instruct the patient in insulin pump management. It may be difficult to successfully implement CSII without the assistance of ancillary health care providers and a team approach. The successful implementation of CSII may be as dependent on a motivated, flexible, and skilled health care team as it is on the patient.

There are no universally applicable criteria for determining which patients will do well on CSII.

: Insulin infusion therapy

Intermittent Intravenous Insulin Therapy - Medical Clinical Policy Bulletins | Aetna

Rapid-acting insulin often used will be NovoRapid® and the long-acting insulin will be Optisulin® glargine. Diabetic Ketoacidosis DKA : the patient will present or display signs of hyperglycaemia high blood glucose , metabolic acidosis low pH , and blood ketone high blood ketone.

Glargine is usually given in the evening. The first dose of basal insulin, usually Glargine, is often given at the same time as the first Rapid acting insulin dose, as the insulin infusion will be ceased and therefore no background insulin will be present.

Often ½ the dose of Glargine calculated by the Endocrinology and Diabetes medical team will be given in the morning and the other ½ or another dose given in the evening. Clarify with Endocrinology and Diabetes Medical team if unsure about Glargine order in MAR.

Levemir can also be used as a first basal insulin to be given in the morning of transition. Later in the evening the Glargine dose can be given.

This allows basal insulin coverage during the day. They may have a Libre 2 sensor and the sensor glucose data this does not replace finger lancing blood glucose or ketone checking — however encourage them to scan device and then perform blood glucose or ketone check too. The Pharmacists associated with the unit are the best resource to accessing and ensuring insulin is available on your unit for patients use and when ordered on the MAR.

Refer to Appendix 2 — Imprest of Insulins at RCH — details of unit location of insulins and pharmacy imprest of insulins. High blood sugar levels can be life threatening without treatment. Doctors refer to high blood sugar levels as hyperglycemia.

IV insulin therapy is a treatment for hyperglycemia. IV insulin therapy is a treatment that healthcare professionals administer in hospitals.

They use IV insulin therapy to reduce blood sugar levels in people with hyperglycemia. IV insulin therapy is a quick way of getting insulin into the bloodstream. Its fast-acting nature makes IV insulin therapy a useful treatment for hyperglycemic emergencies.

Hyperglycemia is common in people with diabetes. However, IV insulin therapy is also useful for treating hyperglycemia due to:. Doctors traditionally only used regular human insulin — a synthetic form of insulin — in IV insulin therapy. However, research from indicates that insulin aspart IVs were beneficial when treating people following heart surgery.

Insulin aspart is another synthetic form of insulin that scientists developed to be fast acting. Another fast-acting synthetic insulin that could be useful is insulin lispro. A doctor may consider the following factors when determining the right type of insulin for IV insulin therapy:.

IV insulin enters straight into the bloodstream and only lasts a few minutes. This means someone may require several hours of IV insulin therapy before their blood sugar levels return to normal. IV insulin therapy involves inserting a thin tube, which doctors refer to as a catheter, into the arm.

The doctor will attach the catheter with a needle that goes directly into a vein. The catheter is also attached to a bag that contains insulin and other liquids, such as saline.

The amount of time a person requires IV insulin therapy can depend on their blood sugar levels. IV insulin therapy can last anywhere between 3—12 hours. Doctors refer to abnormally low blood sugar levels as hypoglycemia. Hypoglycemia can cause other health problems.

People receiving IV insulin treatment will need to transition to subcutaneous insulin after their blood sugar levels become normal.

Proper care is necessary during this process to keep blood sugar levels in a healthy range. The point when a person may transition from IV insulin therapy to subcutaneous insulin may depend on:. Research from suggests the transition from IV insulin to subcutaneous insulin should begin once a person can consume food orally and has stable blood sugar levels.

IV insulin should continue for 1—2 hours after administering subcutaneous insulin. However, the researchers note that further study is necessary to determine the safety and effectiveness of this level of subcutaneous insulin.

The protocol for determining how much IV insulin a person should receive can vary among hospitals. Information from the American Diabetes Association suggests that hospitals consider the following factors when determining the best protocol to use:.

IV insulin therapy can carry certain risks, such as hypoglycemia. Symptoms of hypoglycemia include :. Healthcare professionals use IV insulin therapy to treat people with hyperglycemia. The condition can be due to diabetes or other problems, such as heart disease. IV insulin therapy involves supplying insulin directly into the bloodstream through a catheter.

However, some people require lower levels than this. Doctors will carefully monitor for hypoglycemia during IV insulin therapy.

Discover how regular insulin works and helps manage diabetes. We describe how much regular insulin to take, potential side effects, and other…. Symptoms of high potassium, or hyperkalemia, may include nausea, and difficulty breathing.

Kidney issues are the main cause. Learn more here.

Nursing guidelines Insulin infusion therapy Clin North Insupin. Glycemic Yherapy in Insulin Naive Ketosis and Food Cravings in the Inpatient Setting. Lifestyle Flexibility. Lnfusion recommends the use of Blood circulation supplements reviews multidisciplinary team that would ideally include personnel from the medical staff, nursing, case management, pharmacy, nutrition services, dietary,laboratory, quality improvement, information systems, and administrative divisions. Variability and Rate of Change. Stroke blocks the blood supply to the brain and can be life threatening.
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In , Kanji et al. Patients in the control group received subcutaneous and IV insulin titrated to target glucose ranges at the physicians' discretion.

The interventional cohort received insulin infusion according to a nurse-managed stardardized protocol. Patients included in the interventional group reached their target range more rapidly and maintained blood glucose concentrations in the target range longer compared to the control group.

Several publications and organizations have validated or endorsed the use of nurse-driven protocols. Although a protocol is designed to be somewhat automated, there remain conditions that could predictably affect glucose control. The fear of hypoglycemia limits the willingness of care providers to adopt lower glycemic targets.

Implementation of any tight glycemic control protocol includes a proactive approach to controlling blood glucose while preventing hypoglycemic events. Recognizing predisposing conditions and anticipating those events that could trigger an imbalance between circulating insulin and glucose levels is crucial Table 4.

Protocols designed with increased frequency in testing for patients at high risk for hypoglycemia will result in a reduced length of time spent in the hypoglycemic state.

Insulin infusion protocols allow for titration of IV insulin using small increments of change, thus minimizing the risk of low glucose levels and maximizing options for maintaining tight control.

Hypoglycemia is avoidable, and monitoring of blood glucose is crucial to detecting impending events. Risk reduction requires a protocol designed to prevent occurrences, a management team that that is vigilant in identifying high-risk patients, and an educated staff to implement CII.

Measures to minimize errors that could result in sudden changes in glucose levels should be incorporated into the protocol. These include a standardized drip concentration, appropriate priming, suitable monitoring intervals, blood glucose values that trigger corrective measures, and cues to changes in therapy that put patients at risk.

Hypoglycemia is a predictable and preventable event and should not create a barrier to achieving euglycemia in the hospital setting.

Protocol implementation relies heavily on directed clinician response to accurate blood glucose measurements. Insulin infusion protocols rely on frequent monitoring and rapid results in blood glucose testing.

Hospitals have come to rely on portable monitors as a solution to the need for increased bedside blood glucose testing.

Although technology has improved performance of these meters, several factors can affect results. The leading cause of inaccuracy in POC testing is user error. Several biological factors have been associated with variations in blood glucose values. Sample source, altitude, triglyceride levels, hematocrit, and the presence of nonglucose sugars can all affect meter results.

These drawbacks require careful consideration when selecting a POC testing device. Education, training, and a standardized protocol will drive consistency in practice and minimize error.

Institutions should standardize POC testing devices, ensure adequate supplies of glucose meters to meet staff needs, and educate all staff regarding proper device and sampling techniques. The understanding and support of those involved in development, initiation,and implementation of any tight glycemic control program is essential to its success.

The more staff having a full understanding of the overall picture,the more successful the program will be. A failure to accept the evidence that supports change presents a barrier to achieving euglycemia. A survey of nurses and physicians conducted by McMullin et al. Recognizing and addressing this potential barrier involves the development of integrated ongoing educational strategies.

The rationale is to provide opportunities that will enhance knowledge, improve performance, and offer the support needed to deliver quality care.

The benefits of interactive education and performance feedback are listed in Table 5. Piloting is necessary to ensure that the general concepts and details of the protocol are understood and feasible.

After extensive educational programs designed to inform and empower staff, the team must decide on a roadmap for implementation. A stepped approach is one method often used because it allows staff to better acclimate to changes in practice and familiarize themselves with the fundamentals of the protocol.

The protocol is initially tested in only one ICU, and possibly only one patient, at a time. Often, based on the amount of supporting literature, the cardiovascular or surgical ICU becomes the chosen unit for initiation.

The team must come to agreement with the staff on an acceptable glucose level for initiation and a target glucose range. It is recommended to start with higher target ranges that can be fine-tuned over time to the ultimate goal blood glucose range as the comfort level of the staff increases.

Working with nurse management to assure staffing appropriate to the additional time constraints should also be a consideration. Under the guidance and oversight of the glycemic management team, staff can implement the details of the protocol.

Through repetition, support, and ongoing communication, staff will increase their familiarity with execution of tight glycemic control protocols and build efficiency in performance. Over time,these new behaviors will become the default rather than the exception. IV insulin infusion protocols have generally been reserved for the intensive-care setting.

Studies to support use of CII have primarily been limited to ICUs. However, patients who could benefit from insulin infusion therapy are not restricted to the intensive-care setting. The use of IV insulin protocols has been widely accepted in the treatment of patients presenting with hyperglycemic hyperosmolar state and diabetic ketoacidosis without a requisite admission to the ICU.

Events leading to prolonged hyperglycemia or significant fluctuations in blood glucose levels should not require admission to the ICU for appropriate treatment. Conversely, patients in the ICU who are now clinically stable should not have transfer to a step-down unit or regular medical floor delayed secondary to hospital restrictions regarding IV insulin.

In , a group from Duke University published results of a project evaluating the safety, effectiveness, and feasibility of using an IV insulin algorithm in the general hospital wards.

Expanding implementation of IV insulin protocols requires careful planning,increased education, and evidence to support best-practice measures. For patients who meet criteria for CII but whose clinical status does not warrant admission to or preclude discharge from the ICU, insulin infusion protocols should be developed with looser glycemic targets.

Management of hyperglycemia outside the ICU should prove to be a cost-saving measure. Today, the intensive management of inpatient hyperglycemia is becoming a standard of care. In unstable or critically ill patients, the adoption of near-normal glycemic targets requires the use of IV insulin infusion protocols.

However, institutional and educational limitations have created barriers to the adoption of glycemic targets that will impart the greatest benefit to the inpatient population. The development of protocol-driven programs under the auspices of a multidisciplinary team will best serve to overcome hospital-wide barriers and provide the pathways that will lead to better outcomes for patients experiencing hyperglycemia in the acute-care setting.

D'Hondt, RPh, CDE, is a clinical pharmacist at St. John Hospital and Medical Center in Detroit, Mich. Sign In or Create an Account. Search Dropdown Menu. header search search input Search input auto suggest. filter your search All Content All Journals Diabetes Spectrum.

Advanced Search. User Tools Dropdown. Sign In. Skip Nav Destination Close navigation menu Article navigation. Volume 21, Issue 4. Previous Article Next Article. Rationale for Continuous Insulin Infusion. Clinical Trials. Organizational Recognition of Tight Glycemic Control.

CII Versus Sliding Scale. Variability and Rate of Change. Protocol-Driven Insulin Infusion Therapy. Institutional Support. Glycemic Management Team. Protocol Selection. Point-of-Care POC Testing.

Education Enhances Performance. Implementation: Piloting the Protocol. Should CII be restricted to the ICU? Conclusion: Do No Harm. Article Information. Article Navigation. Continuous Intravenous Insulin: Ready for Prime Time Nancy J.

D'Hondt, RPh, CDE Nancy J. D'Hondt, RPh, CDE. This Site. Google Scholar. Diabetes Spectr ;21 4 — Connected Content. A reference has been published: Inpatient Management of Hyperglycemia and Diabetes.

Get Permissions. toolbar search Search Dropdown Menu. toolbar search search input Search input auto suggest. In Brief Hyperglycemia in the inpatient setting has been linked to poor outcomes.

Table 1. View large. View Large. Table 2. Table 3. Table 4. Conditions That Predispose Patients to Hypoglycemia. Table 5. Benefits of Staff Education. The author thanks Dr.

Darryl M. Nomura for his encouragement, advice, and editorial comments. N Engl J Med. Mayo Clin Proc. Pract Diabetol. Endocrinol Metab Clin North Am. Endocr Pract. National Institutes of Health:Glucontrol study: comparing the effects of two glucose control regimens by insulin in intensive care unit patients [article online].

Accessed 21 June American Diabetes Association: Standards of medical care in diabetes— [Position Statement].

Diabetes Care. J Hosp Med. Crit Care Clin. Eur Heart J. Intens Care Med. Am Fam Phys. Semin Thorac Cardiovasc Surg. Am J Health Syst Pharm. Available online at www. Accessed 20 August Crit Care Med. American College of Endocrinology and American Diabetes Association Task Forces on Inpatient Diabetes: American College of Endocrinology and American Diabetes Association consensus statement on inpatient diabetes and glycemic control: a call to action.

BMC Emerg Med. J Pharm Pract. Crit Care Nurs. Diabetes Educ. American Diabetes Association. View Metrics. Lab tests were drawn at ~week intervals a baseline panel of labs pre-treatment, another lab panel at week, and every 12 weeks thereafter for patients who opted to continue treatment.

The data abstracted from patient charts and questionnaires included lab values [HbA1c, total cholesterol, low-density lipids LDL , triglycerides, and estimated glomerular filtration rate eGFR —all coded as continuous variables], patient demographics age, sex, race, BMI, and diabetes type—all categorical variables , the duration of vibratory sensation from the CTF test in seconds—continuous , and patient-reported health questions 0—10, 1—10, or percentage change—all coded as continuous.

Each patient had between 1 and MII treatments. At each treatment, a Family Nurse Practitioner NP administered the health questionnaire and clanging tuning-fork test CTF to assess neuropathy The descriptive statistics are reported in Table 3B. With the questionnaire, the NP asked each patient a series of standard self-reported health questions, coding their responses on the commonly-used 0—10 or 1—10 scale i.

All the aforementioned measures were assessed at baseline and at each treatment session, and entered by the NP on the patient intake form. All data were subsequently abstracted into the analytic data set. The Institutional Review Board of the academic institution determined that ethical approval for this study was not required in accordance with local legislation and national guidelines, as no individually identifying information was available to the research team.

Separate ordinary least squares regression models were run for the change in each outcome of interest HbA1c, LDL cholesterol, triglycerides, total cholesterol, eGFR, vibratory sensation, and multiple self-reported health questions , comparing each patient's value at time of final or most recent treatment vs.

the patient's baseline measures. Patient encounters that were missing data were omitted from the regression, and Table 2 includes the number of patients with complete data included in each model out of a total of 60 patients with lab results.

Due to the smaller number of subjects, we used t -tests to gauge the significance of differences between patients' continuous self-reported, subjective outcome measures before treatment vs. after final or most recent treatment.

To test for non-linear relationships, we produced a scatter plot of HbA1c by weeks of MII treatment Supplementary Figure 1. We used SAS University Edition version 2. Descriptive statistics for the Lab Test analyses are presented in Tables 1A , B.

Most patients were age 45—64 Sixty percent were female. All but 4 were white Three were prediabetic, 26 Type 1, and 31 Type 2 diabetics. With respect to weight, Table 1A. Baseline descriptive statistics—lab data categorical variables. HbA1c measures ranged from 5.

The results of each model for the Lab Test data are presented in Table 2. The primary explanatory variable of interest, the time variable for months of MII treatment, was associated with reductions in HbA1c levels by 0.

The significance of the F-statistic and magnitude of R 2 coefficient indicate the model is a strong predictor of reduced HbA1c among the diabetic patients in the study. Twenty-six patients had these data in their charts, but no lab results data.

Consequently, the Subjective Data had 86 patients, whereas the lab data had only Patient ages ranged from 19 to 85 with a mean of Fifty-two were female and 34 were male. All but five were white. Four were prediabetic and averaged 11 treatments per patient during the study period. Fifty-three were Type 1 and averaged Number of MII treatments per patient ranged from 1 to Table 3A.

Table 3B. Patients were asked to self-report on 10 health status questions, and the clinic NP measured vibratory sensation in both feet using a Hz clanging tuning fork CTF. Patients reported a mean of 9. Patients reported averages of 7.

Patients were asked to rate their overall percentage health improvement since beginning treatment. Assessed at each treatment encounter, responses indicated a The final five patient self-reported measures and their mean percentage changes were: physical activity change Table 4.

Statistically significant improvements of 3—3. Patient self-reports of feeling better and experiencing improved overall health, 0. We aimed to study relationships between patients' number of weeks in MII treatment changes between baseline and last or most recent treatment and their associated HbA1c, triglycerides, neuropathy symptoms, and self-reported health.

Overall, patients experienced improvements in both lab values and self-reported measures the longer they were in treatment. Table 4 showed short-term reductions in self-reported health scores, and the NP and clinic medical director posited that patients' reports of how they are feeling, diabetic-related pain and overall health may worsen in the short-run as neuropathy symptoms diminish, sensation returns, and they begin to experience pain again.

Our generalized linear models show HbA1c declining approximately 0. Vibratory sensation measures also improved, as did patients' self-reported measures of how they were feeling, and their overall health also improved at statistically significant levels. These findings are also in line with results published over the past 10—20 years, including those of Elliott et al.

Our findings were consistent with some of the earlier research on PII generally, or MII more specifically.

Multiple studies supported the hypothesis that pulsed insulin infusions could be more efficacious than continuous insulin infusion 8 , 9 , 20 — Our results were also consistent with the findings of the systematic literature review by Dong et al. However, most studies of MII have focused on metabolic measures estimated from patients' respiratory O 2 and CO 2 10 , We focused on the lipid, HbA1c, eGFR, neuropathy measures, and patient self-reported health screening questions more commonly used in ambulatory care clinics globally.

Our study is differentiated by incorporating the differences between MII and earlier pulsatile insulin infusion approaches, longer period of study up to 3 years , a relatively large sample size, stronger methodology, and focus on clinical measures more commonly used by clinicians treating diabetics.

Taken together, these differentiating factors make the current research an important addition to the body of literature on diabetes care. This is one of the few studies to empirically study the efficacy of the MII treatment for diabetes in a population large enough to permit statistically valid inferences.

With multiple waves of data on over 80 patients, this is one of the most extensive quantitative studies of microburst insulin infusion therapy conducted to date, with protocols more uniformly implemented and survey instruments more consistently administered by the same clinical team.

Consistent with our hypotheses, we found statistically significant improvements in HbA1c, triglycerides, neuropathy, and 3 self-reported patient survey measures of health and well-being, supporting the hypothesis that the MII therapy is efficacious in treating diabetic patients, particularly those with complications like neuropathy.

This study is also one of the few to implement surveys of patients' self-reported health and quality of life. Like the findings of Dong et al. While this study is pioneering, it has inherent limitations.

Our hypothesis was that MII would show early indications of potential efficacy, using solely existing chart data for patients served from February through December Given frequent contact with patients over time, the Hawthorne effect and regression to the mean may have impacted results.

In the current retrospective cohort study context, we were not able to include a control group, and the t -tests and regression models effectively used subjects as their own controls over weeks of time in treatment.

Sample size is also a concern. While this is one of the largest studies yet conducted on the MII treatment, statistical power was reduced, limiting our options for statistical modeling.

This may also have contributed to lack of statistical significance of the findings for low-density lipids LDL cholesterol and estimated glomerular filtration rate eGFR , measures we expected to improve with time in treatment. The CDC estimates over 30 million Americans have diabetes, and the WHO estimated the global count at over million in and identify the disease as a major cause of heart disease, stroke, blindness, and amputations 2 , 3 , 24 , alone Better managing the degenerative effects of diabetes would not only decrease pain and suffering of patients, but could also save trillions of dollars in direct and indirect costs worldwide.

Given the promising preliminary findings of this retrospective study, further research is warranted. The research team plans a second phase of the study to compare MII results observed to-date with results observed among a retrospective cohort of diabetic patients managed through traditional lifestyle modification diet and exercise treatment protocols at their affiliated academic medical center.

If that study shows comparatively superior outcomes, a multi-center, prospective clinical trial should be pursued. The raw data supporting the conclusions of this article will be made available, subject to approval by the clinic leadership. The studies involving human participants were reviewed and approved by the Saint Louis University Institutional Review Board.

Written informed consent for participation was not required for this study in accordance with the national legislation and the institutional requirements. Data were provided de-identified to the researchers, and the study was deemed exempt.

SH and ZZ managed the entirety of the study. JL and WL provided valuable assistance with literature review, data entry, and writing. ZQ, JT, and RB provided important subject matter consultation, advice on study design, and contributed to the writing process.

All authors contributed to the article and approved the submitted version. SH previously consulted on a clinical improvement and strategic planning project with Mitokon Health Center, the St.

Louis clinic from which the de-identified data were obtained. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, et al. Global and regional diabetes prevalence estimates for and projections for and results from the International Diabetes Federation Diabetes Atlas. Diabetes Res Clin Pract. doi: PubMed Abstract CrossRef Full Text Google Scholar.

World Health Organization. Diabetes Fact Sheet. Centers for Disease Control and Prevention. National Diabetes Statistics Report. Atlanta, GA: Centers for Disease Control and Prevention, U.

Dept of Health and Human Services. pdf accessed June 25, American Diabetes Association. Classification and diagnosis of diabetes: standards of medical care in diabetes Diabetes Care. Hicks CW, Selvin E. Epidemiology of peripheral neuropathy and lower extremity disease in diabetes.

Curr Diab Rep. Wahren J, Kallas Å. Loss of pulsatile insulin secretion: a factor in the pathogenesis of type 2 diabetes? Matveyenko AV, Liuwantara D, Gurlo T, Kirakossian D, Dalla Man C, Cobelli C, et al.

Pulsatile portal vein insulin delivery enhances hepatic insulin action and signaling. Matthews DR, Naylor BA, Jones RG, Ward GM, Turner RC. Pulsatile insulin has greater hypoglycemic effect than continuous delivery. Komjati M, Bratusch-Marrain P, Waldhäusl W.

Superior efficacy of pulsatile versus continuous hormone exposure on hepatic glucose production in vitro. Dong S, Lau H, Chavarria C, Alexander M, Cimler A, Elliott JP, et al. Effects of periodic intensive insulin therapy: an updated review. Curr Ther Res. Elliott J, Zaias N, Escovar S, Deguzman L, Counce D, Dixit R.

J Diabetes Metab Disord Control. CrossRef Full Text Google Scholar. Aoki TT, Benbarka MM, Okimura MC, Arcangeli MA, Walter Jr RM, Wilson LD, et al. Long-term intermittent intravenous insulin therapy and type 1 diabetes mellitus.

IV insulin: Definition, administration, and potential complications While this study Carbohydrate-rich diets pioneering, it has inherent thera;y. Hyperglycemia Insulin infusion therapy therapg inpatient setting has been linked to poor outcomes. Consequently, the Infjsion Data had 86 patients, whereas the lab data had only Jornsay DLDuckles AEHankinson JP Psychological considerations for patient selection and adjustment to insulin pump therapy. Low-dose chemotherapy with insulin insulin potentiation therapy in combination with hormone therapy for treatment of castration-resistant prostate cancer. Dailey GE, Boden GH, Creech RH, et al.
Insulin infusion therapy A, Invusion of 3 Preserving a youthful complexion infusion pumps; Infusjon and C, 2 subcutaneous imfusion Ketosis and Food Cravings Inxulin that may be used for continuous subcutaneous insulin infusion. Infsuion typical profile Replenishing nutrients after a game basal insulin infusion rates used in continuous subcutaneous insulin infusion. It is very common for people with diabetes to require a higher basal infusion of insulin in the predawn hours. Many people are more active in the late afternoon and more sedentary after dinner, requiring downward and upward adjustments, respectively. Lenhard MJReeves GD. Continuous Subcutaneous Insulin Infusion : A Comprehensive Review of Insulin Pump Therapy. Arch Intern Med.

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