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. 2019 Jan;21(1):11-19.
doi: 10.1089/dia.2018.0264. Epub 2018 Dec 26.

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

Gregory P Forlenza  1 , Orit Pinhas-Hamiel  2 , David R Liljenquist  3 , Dorothy I Shulman  4 , Timothy S Bailey  5 , Bruce W Bode  6 , Michael A Wood  7 , Bruce A Buckingham  8 , Kevin B Kaiserman  9 , John Shin  10 , Suiying Huang  10 , Scott W Lee  10 , Francine R Kaufman  10
Affiliations

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

Gregory P Forlenza et al. Diabetes Technol Ther. 2019 Jan.

Abstract

Objective: To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ 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 (HbA1c), 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® 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), HbA1c 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 HbA1c levels and increased time in target glucose range, compared with baseline.

Trial registration: ClinicalTrials.gov NCT02660827.

Keywords: Automated insulin delivery; Closed-loop insulin delivery; Glucose variability.; HbA; Pediatric; Type 1 diabetes.

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Conflict of interest statement

G.P.F, O.P-H., D.R.L., D.I.S., T.S.B., B.W.B., M.A.W., B.A.B., and K.B.K. managed the study conducted at their individual investigational centers, contributed to the analysis and interpretation of results, and reviewed and edited the article. All of the principal investigators received research support and compensation from Medtronic to conduct the study. S.H., J.S., S.W.L., and F.R.K., employees of Medtronic, developed the study design, managed data analyses, and/or reviewed and edited the article. G.P.F., the guarantor of the work, had full access to all of the study data and, as such, takes responsibility for the integrity of the data and the accuracy of the data analysis.

Figures

<b>FIG. 1.</b>
FIG. 1.
Study schedule. The run-in phase involved four visits and was 2 weeks in duration. The study phase involved six visits, including a 6-day/5-night hotel period, and was 3 months in duration. During the hotel study period, participants underwent one 24-h FST with i-STAT venous blood reference measurement. FST, frequent sample testing; PLGM, predictive low glucose management.
<b>FIG. 2.</b>
FIG. 2.
Disposition of study participants.
<b>FIG. 3.</b>
FIG. 3.
Sensor glucose profile during the run-in and study phases. The median and 10th, 25th, 75th, and 90th percentile ranges of sensor glucose values (mg/dL on the left axis and mmol/L on the right axis) throughout the 24-h period are shown for the run-in (R) phase (gray band and dashed lines) and study (S) phase (pink band and solid lines).
See this image and copyright information in PMC

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