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Fully closed-loop glucose control compared to insulin pump therapy with continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glycemic control: a single-centre, randomized, crossover study

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posted on 2023-08-24, 20:11 authored by Charlotte K Boughton, Sara Hartnell, Rama Lakshman, Munachiso Nwokolo, Malgorzata E Wilinska, Julia Ware, Janet M Allen, Mark L Evans, Roman Hovorka

Objective

We evaluated the safety and efficacy of fully closed-loop with ultra-rapid insulin Lispro in adults with type 1 diabetes and sub-optimal glycemic control compared with insulin pump therapy with continuous glucose monitoring (CGM).

Research Design and Methods

In a single-centre, randomized, crossover study, 26 adults with type 1 diabetes using insulin pump therapy with sub-optimal glycemic control (mean±SD, age 41±12 years, HbA1c 9.2±1.1%[77±12mmol/mol]) underwent two 8-week periods of unrestricted living comparing fully closed-loop with ultra-rapid insulin Lispro to insulin pump therapy with CGM in random order. Trial registration:NCT04977908.

Results

In an intention-to-treat analysis, the proportion of time glucose was in range (3.9 to 10.0mmol/L; primary endpoint) was higher during closed-loop than during pump with CGM (mean±SD 50.0±9.6% vs. 36.2±12.2%; mean difference 13.2 percentage points [95%CI 9.5 to 16.9]; P<0.001). Time with glucose above >10.0mmol/L and mean glucose were lower during closed-loop than during pump with CGM (mean±SD time >10.0mmol/L: 49.0±9.9% vs. 62.9±12.6%; mean difference -13.3 percentage points [95%CI -17.2 to -9.5], P<0.001; mean glucose 10.7±1.1mmol/L vs 12.0±1.6mmol/L; mean difference -1.2mmol/L [95%CI -1.8 to -0.7], P<0.001). The proportion of time with glucose <3.9mmol/L was similar between periods (median[IQR] closed-loop 0.88% [0.51-1.55] vs. pump with CGM 0.64% [0.28-1.10]; P=0.102). Total daily insulin requirements did not differ (median[IQR] closed-loop 51.9units/day [35.7-91.2] vs. pump with CGM 50.7units/day [34.0-70.0]; P=0.704). No severe hypoglycaemia or ketoacidosis occurred.

Conclusions

Fully closed-loop insulin delivery with CamAPS HX improved glucose control compared to insulin pump therapy with CGM in adults with type 1 diabetes and sub-optimal glycemic control.


Funding

Supported by National Institute for Health Research Cambridge Biomedical Research Centre. The views expressed are those of the author(s) and not necessarily those of the NIHR, the Department of Health and Social Care, or other funders.

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