Glycemic outcomes of children 2–6 years of age with type 1 diabetes during the pediatric MiniMed ™ 670G system trial

Abstract

Background Highly variable insulin sensitivity, susceptibility to hypoglycemia and inability to effectively communicate hypoglycemic symptoms pose significant challenges for young children with type 1 diabetes (T1D). Herein, outcomes during clinical MiniMed™ 670G system use were evaluated in children aged 2–6 years with T1D. Methods Participants (N = 46, aged 4.6 ± 1.4 years) at seven investigational centers used the MiniMed™ 670G system in Manual Mode during a two‐week run‐in period followed by Auto Mode during a three‐month study phase. Safety events, mean A1C, sensor glucose (SG), and percentage of time spent in (TIR, 70–180 mg/dl), below (TBR, <70 mg/dl) and above (TAR, >180 mg/dl) range were assessed for the run‐in and study phase and compared using a paired t‐test or Wilcoxon signed‐rank test. Results From run‐in to end of study (median 87.1% time in auto mode), mean A1C and SG changed from 8.0 ± 0.9% to 7.5 ± 0.6% (p < 0.001) and from 173 ± 24 to 161 ± 16 mg/dl (p < 0.001), respectively. Overall TIR increased from 55.7 ± 13.4% to 63.8 ± 9.4% (p < 0.001), while TBR and TAR decreased from 3.3 ± 2.5% to 3.2 ± 1.6% (p = 0.996) and 41.0 ± 14.7% to 33.0 ± 9.9% (p < 0.001), respectively. Overnight TBR remained unchanged and TAR was further improved 12:00 am–6:00 am. Throughout the study phase, there were no episodes of severe hypoglycemia or diabetic ketoacidosis (DKA) and no serious adverse device‐related events. Conclusions At‐home MiniMed™ 670G Auto Mode use by young children safely improved glycemic outcomes compared to two‐week open‐loop Manual Mode use. The improvements are similar to those observed in older children, adolescents and adults with T1D using the same system for the same duration of time.

In‐home use of a hybrid closed loop achieves time‐in‐range targets in preschoolers and school children: Results from a randomized, controlled, crossover trial

“…GMI, glucose management indicator; SG, sensor glucose; SAP, sensor-augmented pump; TBR, time below range; TIR, time in range (50%). That was comparable or even better than the results reported for multicentre US pivotal studies in preschoolers 19 and school children. 18 In school children, this represents a doubling of the percentage of users achieving the target.…”

“…The present study found a high rate of TIR target achievement using the MiniMed 670G system in preschoolers (88%) and school children (50%). That was comparable or even better than the results reported for multicentre US pivotal studies in preschoolers 19 and school children 18 . In school children, this represents a doubling of the percentage of users achieving the target.…”

“…In pivotal multicentre trials compared with SAP without basal rate modulation, in adults, the Medtronic Minimed 670G system gave a 7% increase to 74% TIR (70‐180 mg/dl), 16 in adolescents (aged 14‐21 years) an 11% increase to 67% TIR, 17 in school children a 16% increase to 65% TIR 18 and, recently, in preschoolers, a 14% increase to 64% TIR 19 . Despite clinically significant improvements of more than 5% compared with SAP, the recommended TIR target of more than 70% TIR was not achieved on average in these trials in the paediatric populations.…”

Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial

“…Exploration of AID systems in very young children has been sparse. The single system available for use in this age-group in both the U.S. and Europe resulted in mean ± SD HbA 1c 7.5 ± 0.6% (58 ± 6.6 mmol/mol) and increase in TIR to 63.8% (increase of 8.1%), while mean time with glucose level <70 mg/dL was unchanged at 3.2% (10). In a recent evaluation of the other system available in this age-group (Europe only), TIR was 71.6 ± 5.9%, while median time <70 mg/dL was 4.9% (11).…”

“…studies of AID systems have demonstrated improvement in glycemia without increased self-care burden (7)(8)(9); however, exploration of this technology in very young children has been sparse (10,11). It is critical to study new therapies that may allow more targeted glycemia in this age-group.…”