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Diabetes Technol Ther. 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.

Author information

1
1 Barbara Davis Center for Childhood Diabetes, Aurora, Colorado.
2
2 Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Tel Aviv, Israel.
3
3 Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho.
4
4 USF Diabetes Center, Morsani College of Medicine, University of South Florida, Tampa, Florida.
5
5 AMCR Institute, Escondido, California.
6
6 Atlanta Diabetes Associates, Atlanta, Georgia.
7
7 University of Michigan Medical School, Ann Arbor, Michigan.
8
8 Department of Pediatric Endocrinology, Stanford University, Stanford, California.
9
9 SoCal Diabetes, Torrance, California.
10
10 Medtronic, Northridge, California.

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

PMID:
30585770
PMCID:
PMC6350071
DOI:
10.1089/dia.2018.0264
[Indexed for MEDLINE]
Free PMC Article

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