Background
The objective of this study was to evaluate the glycemic outcomes in children and adolescents with Type 1 Diabetes (T1D) previously treated with Multiple Daily Injections (MDI) using a structured initiation protocol for the Advanced Hybrid Closed Loop (AHCL) Minimed 780G insulin pump system.
Methods
In this prospective open label single-arm, single-center, clinical investigation, we recruited children and adolescents (aged 7–17 years) with T1D on MDI therapy and HbA1c below 12.5%. All participants followed a 10-day structured initiation protocol which included 4 steps: step 1: AHCL system assessment; step 2: AHCL system training; step 3: Sensor augmented pump therapy (SAP) for 3 days; step 4: AHCL system use for 12 weeks, successfully completing the training from MDI to AHCL in 10 days. The primary outcome of the study was the change in the time spent in the target in range (TIR) of 70–180 mg/dl and HbA1c from baseline (MDI + CGM, 1 week) to study phase (AHCL, 12 weeks). The paired student t-test was used for statistical analysis and a value < 0.05 was considered statistically significant.
Results
Thirty-four participants were recruited and all completed the 12 weeks study. TIR increased from 42.1 ± 18.7% at baseline to 78.8 ± 6.1% in the study phase (p < 0.001). HbA1c decreased from 8.6 ± 1.7% (70 ± 18.6 mmol/mol) at baseline, to 6.5 ± 0.7% (48 ± 7.7 mmol/mol) at the end of the study (p = 0.001). No episodes of severe hypoglycemia or DKA were reported.
Conclusion
Children and adolescents with T1D on MDI therapy who initiated the AHCL system following a 10-days structured protocol achieved the internationally recommended goals of glycemic control with TIR > 70% and a HbA1c of < 7%.
OBJECTIVE
We aimed to compare glucose control in adolescents with type 1 diabetes (T1D) using the MiniMed 780G system who used simplified meal announcement with those who used precise carbohydrate counting.
RESEARCH DESIGN AND METHODS
This randomized controlled trial included 34 participants (age 12–18 years) with T1D who were on multiple daily injections or insulin pump and were scheduled to start using the MiniMed 780G system at Sidra Medicine in Qatar. After a 7-day run-in period, participants were randomly assigned to the fix group (simplified meal announcement by preset of three personalized fixed carbohydrate amounts) or the flex group (precise carbohydrate counting) and followed for 12 weeks. Between-group difference in time in range (TIR) was the primary end point. Secondary end points included HbA1c and other glycometrics.
RESULTS
During the 12-week study phase, TIR was 73.5 ± 6.7% in the fix and 80.3 ± 7.4% in the flex group, with a between-group difference of 6.8% in favor of flex (P = 0.043). Time >250 mg/dL was better in the flex group (P = 0.012), whereas HbA1c (P = 0.168), time below range (P = 0.283), and time between 180 and 250 mg/dL (P = 0.114) did not differ.
CONCLUSIONS
Adolescents using the MiniMed 780G system with a preset of three personalized fixed carbohydrate amounts can reach international targets of glycemic control. Therefore, it may be a valuable alternative to precise carbohydrate counting in users who are challenged by precise carbohydrate counting. Because carbohydrate counting further improves outcomes, these skills remain important for MiniMed 780G users.
The advanced hybrid closed loop system MiniMed 780G can be an effective tool to improve glycemic control and decrease the health burden in a young male with type 1 diabetes and short stature.
<p> </p>
<p><strong>Objective</strong>. We aimed to compare glucose control in adolescents with Type 1 Diabetes (T1D) on MiniMed 780G system that used simplified meal announcement to those that used precise carbohydrate counting. </p>
<p><strong>Research Design and Methods.</strong> This randomized controlled trial included 34 participants (12-18 years) with T1D that were on multiple daily injections or insulin pump and were scheduled to start using MiniMed 780G system at Sidra Medicine, Qatar. After a 7-day run-in period, participants were randomly assigned to the Fix group (simplified meal announcement by preset of 3 personalized fixed carbohydrate amounts) or the Flex group (precise carbohydrate counting) and followed for 12 weeks. Between-group difference in time in range (TIR) was the primary endpoint. Secondary endpoints included HbA1c and other glycometrics.</p>
<p><strong>Results</strong>. During the 12-week study phase, TIR was 73.5±6.7% in the Fix and 80.3±7.4% in the Flex group, with a between-group difference of 6.8% in favor of Flex (p=0.043). Time above 250 mg/dl was better in the Flex group (p=0.012), whereas HbA1c (p=0.168), time below range (p=0.283) and time between 180-250 mg/dL (p=0.114) did not differ. </p>
<p><strong>Conclusion. </strong>Adolescents on the MiniMed 780G system using a preset of 3 personalized fixed carbohydrate amounts can reach international targets of glycemic control. Therefore, it may be a valuable alternative to precise carbohydrate counting in users who are challenged by precise carbohydrate counting. Because carbohydrate counting further improves outcomes, these skills remain important for MiniMed 780G users. </p>
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