TY - JOUR
T1 - Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes
AU - Forlenza, Gregory P.
AU - Pinhas-Hamiel, Orit
AU - Liljenquist, David R.
AU - Shulman, Dorothy I.
AU - Bailey, Timothy S.
AU - Bode, Bruce W.
AU - Wood, Michael A.
AU - Buckingham, Bruce A.
AU - Kaiserman, Kevin B.
AU - Shin, John
AU - Huang, Suiying
AU - Lee, Scott W.
AU - Kaufman, Francine R.
N1 - Publisher Copyright:
© Gregory P. Forlenza, et al., 2019; Published by Mary Ann Liebert, Inc. 2019.
PY - 2019/1
Y1 - 2019/1
N2 - 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 (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 ® 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.
AB - 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 (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 ® 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.
KW - Automated insulin delivery
KW - Closed-loop insulin delivery
KW - Glucose variability
KW - HbA1c
KW - Pediatric
KW - Type 1 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85059796120&partnerID=8YFLogxK
U2 - 10.1089/dia.2018.0264
DO - 10.1089/dia.2018.0264
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C2 - 30585770
AN - SCOPUS:85059796120
SN - 1520-9156
VL - 21
SP - 11
EP - 19
JO - Diabetes Technology and Therapeutics
JF - Diabetes Technology and Therapeutics
IS - 1
ER -
