Figure 1 depicts a high-level overview of the study design. The study was approved by the institutional review board at Sidra Medicine and the national ethics committee of the Ministry of Public Health in Qatar. Participants were consecutively recruited at regular clinic visits.

During this run-in period, participants used the MiniMed G system for real-time continuous glucose monitoring CGM without any insulin delivery by the MiniMed G pump participants on MDI therapy remained on manual injections, and participants already on insulin pump therapy continued to use their previous model for insulin injections , and these CGM data were used for baseline glycemic metrics.

Participants were randomly assigned to either the fix group or the flex group. A permuted block randomization scheme was used. Block size was fixed at 6. Neither the investigators nor the participants and parents were masked to the treatment allocation. In brief, participants started using the MiniMed G system in open loop for 3 days SAP period for the MiniMed G algorithm to establish personalized parameters required for system initiation.

The MiniMed G system was then initiated for all, and the participants used the meal management approach of their allocated group. Participants in the fix group could choose among a preset of three fixed carbohydrate amounts for each meal announcement.

These fixed amounts were personalized based on the 7-day diary; the carbohydrate amounts for a regular meal was set at 40—70 g, for a large meal at 60—90 g, and for a snack at 15—20 g. Fixed amounts for meals were rounded to tens and for snacks, to fives. During individual consultations, a registered dietitian instructed the participants in the fix group to choose the appropriate personalized preset i.

Participants in the flex group were instructed to use precise carbohydrate counting with increments of 1 g. No restriction in dietary intake or daily activities were advised during the study for both groups. Supplementary Table 1 shows the settings at MiniMed G system initiation, as well as the methods for calculating the fixed carbohydrate amounts.

Onsite follow-up visits were scheduled 2 and 12 weeks after initiating the MiniMed G system, and phone visits were scheduled after weeks 1, 4, and 8.

Meal announcement as well as the insulin-to-carbohydrate ratio ICR were reassessed after weeks 1 and 2 and adjusted per clinical judgment if needed in both groups.

Adherence to the correct meal announcement strategy was reviewed and corrected if needed at every visit in both groups. Clinical and technical support was available during the study.

Standard local hypoglycemia and hyperglycemia treatment guidelines were followed. Funds to cover devices were secured through medical insurance, self-funding, and donations made by the Qatar Diabetes Association for participants who could not afford the device.

There were no rejections because of funding constraints. Secondary outcomes were between-group differences in HbA 1c , other CGM-derived metrics for glycemic control including time above range, time below range [TBR], mean sensor glucose, SD, and coefficient of variation [CV] , metrics for meal announcement and insulin use including number of announced meals, announced grams of carbohydrates, the insulin total daily dose [TDD], and a breakdown of the delivered insulin in autobasal, autocorrection, and manual bolus , metrics for system settings including ICR, use of optimal settings, and sensor use , and safety.

An overview of the primary and secondary end points is shown in Tables 2 and 3. As a secondary analysis, within-group changes in metrics for glycemic control were evaluated separately for the fix and the flex group.

This analysis was done for the entire week study period and for the different study periods i. HbA 1c was collected by a point-of-care DCA Vantage Analyzer Siemens Healthineers, Erlangen, Germany. Insulin and CGM data were collected from CareLink therapy management software.

The study hypothesis was that the flex group is expected to show better glycemic control compared with the fix group.

In addition, we wanted to learn whether the fix group still reaches international targets for glycemic control. On the basis of the hypothesis as well as an α of 0. To allow for dropouts, we planned to enroll All analyses were performed for the entire study population.

Between-group differences were analyzed using paired Student t test or paired Wilcoxon test in case of nonnormality. Within-group differences were analyzed using ANOVA.

A two-sided α-level of 0. Statistical analyses were performed using Statistica 12 StatSoft, Tulsa, OK. All participants completed the week follow-up and were included in the analyses.

The enrollment scheme is shown in Fig. Table 2 shows the glycemic control during the study. HbA 1c decreased from 8.

Data are mean ± SD. Study indicates 12 weeks of MiniMed G system use. CGM data at baseline were collected using the Guardian 4 sensor with the MiniMed G system for a 1-week period of training no insulin delivery with pump.

Fix group averages over the last 4 weeks were TIR during different study periods. Data are percentage of TIR during the interval. Baseline data were collected using the Guardian 4 sensor with the MiniMed G system for a 1-week period of training.

AHCL, advanced hybrid closed loop. Table 3 shows insulin delivery and carbohydrate announcement during the study. The TDD increased by 0. Basal insulin as a percentage of TDD decreased by 9.

At the end of the study, the amount of insulin delivered by autocorrection was almost twice as high in the fix group compared with the flex group The manual bolus amount was lower in the fix group than in the flex group The total daily announced carbohydrates did not differ between the groups at study end ± 66 vs.

In addition, participants in the fix group announced fewer meals per day compared with the flex group 3. There was no difference in the carbohydrate amounts that individuals announced for snack, regular meal, and large meal at the beginning versus the end of the study.

Table 3 shows system use at baseline and during the study. The number of exits per patient per week did not differ between the groups and was 0. The number of finger pricks i. Infusion sets and reservoirs were changed approximately every 2—3 days.

No serious adverse events or episodes of severe hypoglycemia or hyperglycemia with ketosis were reported in both groups. Skin irritations related to sensor use occurred in two participants in the fix group and three participants in the flex group.

Two participants from the fix group had mild respiratory tract infections. All reported adverse events were resolved without sequelae. Figure 2 shows the TIR during the different study periods from baseline to using the MiniMed G system. Time above range decreased over time.

The ICR in the fix group was adjusted during the study phase from In the flex group, adjustments were from All participants used one ICR over a h period, and no further changes were made after the 2nd week of MiniMed G usage. In this study, we investigated glycemic control in adolescents using the MiniMed G system with a relatively simple mode of meal announcement, including a preset of three different personalized fixed-carbohydrate amounts fix group compared with MiniMed G users who performed precise carbohydrate counting flex group.

The key finding of this study is that glycemic control as achieved in the flex group was superior to that achieved in the fix group. Took me awhile to find a mix that I like drinking while training - this one has a light flavour that is very enjoyable!

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Here it is:. This method assumes little breakdown and absorption of fibers and sugar alcohols present in food and, therefore, should not be included in carb counts.

In terms of breakdown and absorption, fibers especially soluble and sugar alcohols are a mixed bag, consequently affecting blood sugar. Therefore, the diabetes carb count method was created See below. Tip: If you have diabetes and use net carbs to dose your insulin, consider talking with your doctor or diabetes educator about using the diabetes carb count method.

This carb counting method is considered most accurate for those who take insulin and require exact estimated grams of absorbed carbs. Diabetes self-management classes usually teach this method.

However, it is still an estimate. If you use an insulin-to-carb ratio to dispense rapid-acting insulin at meals or if you were recently diagnosed and educated , you most likely use this updated carb count formula:.

To illustrate this diabetes carb calculation using the above formula, check out figures from the Nutrition Facts label for a snack bar by Atkins and an example of how this formula is used. The Advantage Caramel Peanut Butter Nougat bar contains the following:. Suppose fiber or sugar alcohol content is less than five grams per serving.

In that case, the adjustment will make little difference in the carb count, so you can simply use "total carbohydrates" instead. Logging what you eat and paying attention to the carb content of foods are critical to understanding how different food and lifestyle factors affect your blood sugar and weight.