Abstract
Background: The MiniMed™ 780G system includes an advanced hybrid closed loop (AHCL) algorithm that provides both automated basal and correction bolus insulin delivery. The preliminary performance of the system in real-world settings was evaluated.Methods: Data uploaded from August 2020 to March 2021 by individuals living in Belgium, Finland, Italy, the Netherlands, Qatar, South Africa, Sweden, Switzerland, and the United Kingdom were aggregated and retrospectively analyzed to determine the mean glucose management indicator (GMI), percentage of time spent within (TIR), below (TBR), and above (TAR) glycemic ranges, system use, and insulin consumption in users having ≥10 days of sensor glucose (SG) data after initiating AHCL. The impact of initiating AHCL was evaluated in a subgroup of users also having ≥10 days of SG data, before AHCL initiation.Results: Users (N = 4120) were observed for a mean of 54 ± 32 days. During this time, they spent a mean of 94.1% ± 11.4% of the time in AHCL and achieved a mean GMI of 6.8% ± 0.3%, TIR of 76.2% ± 9.1%, TBR <70 of 2.5% ± 2.1%, and TAR >180 of 21.3% ± 9.4%, after initiating AHCL. There were 77.3% and 79.0% of users who achieved a TIR >70% and a GMI of <7.0%, respectively. Users for whom comparison with pre-AHCL was possible (N = 812) reduced their GMI by 0.4% ± 0.4% (P = 0.005) and increased their TIR by 12.1% ± 10.5% (P < 0.0001), post-AHCL initiation. More users achieved the glycemic treatment goals of GMI <7.0% (37.6% vs. 75.2%, P < 0.0001) and TIR >70% (34.6% vs. 74.9%, P < 0.0001) when compared with pre-AHCL initiation.Conclusion: Most MiniMed 780G system users achieved TIR >70% and GMI <7%, while minimizing hypoglycemia, in a real-world condition.
Highlights
Data uploaded from August 2020 to March 2021 by individuals living in Belgium, Finland, Italy, the Netherlands, Qatar, South Africa, Sweden, Switzerland and the United Kingdom were aggregated and retrospectively analyzed to determine the mean Glucose Management Indicator (GMI), percentage of time spent within (TIR), below (TBR) and above (TAR) glycemic ranges, system use and insulin consumption in users having ≥10 days of sensor glucose (SG) data after initiating Advanced Hybrid Closed Loop (AHCL)
The paradigm shift in the treatment of type 1 diabetes mellitus (T1DM) from regimens based on extrapolation of historical data to algorithm-controlled insulin delivery systems based on real-time continuous glucose monitoring (CGM) has changed the clinical landscape by providing new therapeutic targets, as well as a leap in the proportion of people with T1DM safely achieving these goals
The mean sensor glucose (SG) levels and glucose management indicator (GMI) were assessed, as well as the sensor use, percentage of time spent in AHCL, number of self-monitored blood glucose (SMBG) measurements, insulin delivery patterns and the system settings
Summary
Results: Users (N=4120) were observed for a mean of 54±32 days During this time, they spent a mean of 94.1±11.4% of the time in AHCL and achieved a mean GMI of 6.8±0.3%, TIR of 76.2±9.1%, TBR180 of 21.3±9.4%, after initiating AHCL. More users achieved the glycemic treatment goals of GMI
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