Safety Evaluation of the MiniMed 670G System in Children 7–13 Years of Age with Type 1 Diabetes

Abstract

Objective: To evaluate the safety of in-home use of the MiniMedÔ 670G system with SmartGuardÔ technology in children with type 1 diabetes (T1D). Methods: Participants (N = 105, ages 7-13 years, mean age 10.8-1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week baseline run-in phase in Manual Mode followed by a 3-month study phase with Auto Mode enabled. Sensor glucose (SG), glycated hemoglobin (HbA 1c), percentage of SG values across glucose ranges, and SG variability, during the run-in and study phases were compared. Participants underwent frequent sample testing with i-STAT Ò venous reference measurement during a hotel period (6 days/5 nights) to evaluate the system's continuous glucose monitoring performance. Results: Auto Mode was used a median of 81% of the time. From baseline to end of study, overall SG dropped by 6.9-17.2 mg/dL (P < 0.001), HbA 1c decreased from 7.9%-0.8% to 7.5%-0.6% (P < 0.001), percentage of time in target glucose range (70-180 mg/dL) increased from 56.2%-11.4% to 65.0%-7.7% (P < 0.001), and the SG coefficient of variation decreased from 39.6%-5.4% to 38.5%-3.8% (P = 0.009). The percentage of SG values within target glucose range was 68.2%-9.1% and that of i-STAT reference values was 65.6%-17.7%. The percentage of values within 20%/20 of the i-STAT reference was 85.2%. There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the study phase. Conclusion: In-home use of MiniMed 670G system Auto Mode for 3 months by children with T1D, similar to MiniMed 670G system use by adolescents and adults with T1D, was safe and associated with reduced HbA 1c levels and increased time in target glucose range, compared with baseline.

Increased proportion of time in hybrid closed‐loop “Auto Mode” is associated with improved glycaemic control for adolescent and young patients with adult type 1 diabetes using the MiniMed 670G insulin pump

“…Likewise, each 8.6‐h increase in Auto Mode time per day was associated with 5% more TIR. These findings are consistent with previous 670G trials that demonstrated improvements in glycaemia, including increased TIR and reduction in HbA1c . The ability of automated insulin delivery to improve glycaemia may particularly benefit adolescents and young adults, who have mostly struggled with meeting therapeutic targets.…”

“…In conclusion, whereas the MiniMed 670G system has demonstrated the potential to improve glycaemic outcomes, our findings suggest that these improvements are diminished when time spent in HCL is limited by frequent Auto Mode exits. In our clinical practice and other recently published cohorts, time spent in Auto Mode is substantially lower than in previously published trials . Future automated insulin delivery systems that reduce the burden of staying in the closed‐loop mode have the potential to enhance glycaemic control substantially in the paediatric and adolescent T1DM population.…”

“…trials that demonstrated improvements in glycaemia, including increased TIR 1-4 and reduction in HbA1c. 1,3,4 The ability of automated insulin delivery to improve glycaemia may particularly benefit adolescents and young adults, who have mostly struggled with meeting therapeutic targets. In the T1DM Exchange Registry cohort, only 17% of 6 These data suggest increasing Auto Mode time has the potential to aid in reducing the risk of long-term diabetes complications.…”

“…In our clinical practice and other recently published cohorts, 7 time spent in Auto Mode is substantially lower than in previously published trials. 1,3,4 Future automated insulin delivery systems that reduce the burden of staying in the closed-loop mode have the potential to enhance glycaemic control substantially in the paediatric and adolescent T1DM population.…”

“…70-180 mg/dL), [1][2][3][4] reduced glycaemic variability 3,4 and lower haemoglobin A1c (HbA1c). 1,3,4 However, in our paediatric practice, the proportion of time that patients spend in Auto Mode varies considerably. Patients report the 670G system frequently exits from Auto Mode to Manual Mode for several reasons including sustained hyperglycaemia, not providing sensor calibrations at the appropriate time and inconsistent sensor readings.…”