Retrospective Analysis of 3-Month Real-World Glucose Data After the MiniMed 670G System Commercial Launch

Abstract

Real-world data from the first 3141 patients who completed 3 months of SmartGuard™ Auto Mode-enabled MiniMed™ 670G system use during the MiniMed 670G System Commercial Launch are reported. CareLink™ system data uploaded by real-world patients in the Commercial Launch from March 17, 2017 to December 31, 2017 were deidentified and analyzed. Comparisons of overall and night (10:00 PM-07:00 AM) time spent below, within, and above target glucose range (TIR) (70-180 mg/dL) between the baseline Manual Mode and closed-loop Auto Mode periods were made. These were evaluated alongside data from the 124 patients (aged 14-75 years) who completed the 3-month MiniMed 670G system pivotal trial (NCT 2463097), from June 2, 2015 to March 7, 2016. Real-world patients used Auto Mode a median 80.8% of the time (19 h and 24 min of the day). The overall mean of time spent in TIR was 66.0% during baseline Manual Mode versus 73.3% during Auto Mode (P < 0.001); the mean percentage of sensor glucose values <70 mg/dL was 2.7% versus 2.1% (P < 0.001); and that >180 mg/dL was 31.4% versus 24.6% (P < 0.001). The nighttime and early morning (03:00 AM-06:00 AM) TIR during Auto Mode was greater than that during baseline Manual Mode (nighttime: 77.2% vs. 67.4% [P < 0.001], early morning: 70.9% vs. 84.6% [P < 0.001]). Similar differences between Manual Mode and Auto Mode TIR were observed across different age groups. A slight increase in total insulin delivered was also observed. Consistent with improved glycemic control demonstrated in the pivotal trial, analysis of CareLink system data from >3000 real-world patients who completed 3 months of Auto Mode-enabled MiniMed 670G system use demonstrated increased TIR and decreased time below and above TIR compared with baseline. These improved clinical outcomes were observed across a broad age range of patients with type 1 diabetes.

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.…”

“…This automated insulin delivery system provides insulin using either its HCL “Auto Mode” feature or an open‐loop “Manual Mode”. The 670G pivotal trial and larger real‐world studies show that glycaemia improves after initiation of Auto Mode in both paediatric and adolescent populations . These improvements include increased time in range (TIR, defined as sensor glucose, SG, 70–180 mg/dL), reduced glycaemic variability and lower haemoglobin A1c (HbA1c) .…”

“…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.…”

Going beyond HbA1c to understand the benefits of advanced diabetes therapies

“…Time in target range increased from 64% to >70%, time below target range of <70 mg/dL (<3.9 mmol/L) decreased by 30% (from 2.6% to 2.0%), and CV decreased from 33% to 30% in adult subjects . The real‐world experience in over 3000 patients using the device after its commercial launch in the US has mirrored the pivotal study results . The next steps in AP system development will involve better algorithms that include meal detection and contextual information and, most importantly, improved insulins pharmacokinetics.…”

DIY artificial pancreas systems: here to stay?

“…In between times, the pump regulates insulin delivery with the aim of keeping the glucose in the target range. This system has shown favourable outcomes in real‐world observational data with over 3141 users in the USA with a mean time in range (3.9–10mmol/L) of 73% during automode …”