10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes

Goran Petrovski, Fawziya Al Khalaf, Judith Campbell, Hannah Fisher, Fareeda Umer, Khalid Hussain, Goran Petrovski, Fawziya Al Khalaf, Judith Campbell, Hannah Fisher, Fareeda Umer, Khalid Hussain

Abstract

Aim: The aim of this study was to evaluate the 10-day initiation protocol for MiniMed 670G hybrid closed-loop (HCL) system in individuals with type 1 diabetes on multiple daily injection (MDI) in achieving desirable glycemic control.

Methods: An open-label single-arm, single-center, clinical investigation in children aged 7-18 years on MDI following a structured protocol: 2 days, HCL system assessment; 5 days, HCL system training (2-h sessions on 5 consecutive days with groups of 3-5 participants and families); 3 days, Manual Mode use of HCL system; 84 days, Auto Mode use of the HCL system, cumulating in 10 days from MDI to Auto Mode activation.

Results: A total of 30 children (age 10.24 ± 2.6 years) were enrolled in the study, and all completed the planned 84 days on Auto Mode. The participants used the sensor for a median of 92% of the time and spent a median of 89% in Auto Mode. The mean HbA1c decreased from 8.2 ± 1.4% (66 ± 15.3 mmol/mol) at baseline to 6.7 ± 0.5% (50 ± 5.5 mmol/mol) at the end of the study (p = 0.017). Time in range (70-180 mg/dL) increased from 46.9 ± 18.5% at baseline to 75.6 ± 6.9% in Auto Mode (p < 0.001). This was achieved while spending 2.8% of the time below 70 mg/dL and without any severe hypoglycemia or DKA.

Conclusion: Children and adolescents with type 1 diabetes on MDI therapy can successfully initiate the HCL system, using a concise structured 10-day protocol.

Keywords: Hybrid closed-loop system; Multiple daily injection; Protocol; Type 1 diabetes.

Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Time in ranges at baseline, during Manual Mode and Auto Mode periods. Values are shown as percentage spent in ranges during the interval. MDI multiple daily injections, CGM continuous glucose monitoring. Glucose values < 50 mg/dL are not shown on the graph: 0.3% in Manual Mode and Auto Mode period day 57–84, 0.4% in all other periods

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Source: PubMed

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