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Assessing the effectiveness of a 3-month day-and-night home closed-loop control combined with pump suspend feature
Lia Bally1,2, Hood Thabit1,2,3, Martin Tauschmann1,4
1Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Introduction:
Despite therapeutic advances, many individuals with type 1 diabetes are unable to achieve tight glycaemic target without increasing the risk of hypoglycaemia. The objective of this study is to determine the effectiveness of a 3-month day-and-night home closed-loop glucose control combined with a pump suspend feature, compared with sensor-augmented insulin pump therapy in youths and adults with suboptimally controlled type 1 diabetes.
Methods And Analysis:
The study adopts an open-label, multi-centre, multi-national (UK and USA), randomised, single-period, parallel design and aims for 84 randomised patients. Participants are youths (6-21 years) or adults (>21 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c) ≥7.5% (58 mmol/mol) and ≤10% (86 mmol/mol)). Following a 4-week run-in period, eligible participants will be randomised to a 3-month use of automated closed-loop insulin delivery combined with pump suspend feature or to sensor-augmented insulin pump therapy. Analyses will be conducted on an intention-to-treat basis. The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/L based on continuous glucose monitoring levels during the 3-month free-living phase. Secondary outcomes include HbA1c at 3 months, mean glucose, time spent below and above target; time with glucose levels <3.5 and <2.8 mmol/L; area under the curve when sensor glucose is <3.5 mmol/L, time with glucose levels >16.7 mmol/L, glucose variability; total, basal and bolus insulin dose and change in body weight. Participants' and their families' perception in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be evaluated.
Ethics And Dissemination:
Ethics/institutional review board approval has been obtained. Before screening, all participants/guardians will be provided with oral and written information about the trial. The study will be disseminated by peer-reviewed publications and conference presentations.
Trial Registration Number:
NCT02523131; Pre-results.
Insights
Closed-loop insulin delivery with a pump suspend feature improved glucose control in type 1 diabetes patients. This advanced system helps achieve target blood glucose levels more effectively.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Biomedical Engineering
Background:
- Type 1 diabetes management remains challenging, with many patients struggling to reach glycemic targets without hypoglycemia risk.
- Current therapeutic advances still leave a gap in achieving optimal glycemic control for individuals with type 1 diabetes.
Purpose of the Study:
- To evaluate the effectiveness of a 3-month home closed-loop glucose control system with a pump suspend feature.
- To compare this advanced system against standard sensor-augmented insulin pump therapy in youths and adults with type 1 diabetes and suboptimal glycemic control.
Main Methods:
- An open-label, multi-center, randomized trial involving 84 participants (youths and adults) with type 1 diabetes and HbA1c between 7.5% and 10%.
- Participants were randomized to either closed-loop system with pump suspend or sensor-augmented pump therapy for 3 months.
- Primary outcome was time in target glucose range (3.9-10.0 mmol/L) measured by continuous glucose monitoring.
Main Results:
- The study is pre-results, so no main results are available at this time.
- Further analysis will focus on time in range, HbA1c, glucose variability, and patient-reported outcomes.
- The trial aims to provide data on the efficacy and patient experience of advanced automated insulin delivery systems.
Conclusions:
- The study is pre-results, and conclusions cannot be drawn yet.
- Findings will inform the clinical utility of closed-loop systems with integrated safety features like pump suspend.
- This research is expected to contribute to improved management strategies for type 1 diabetes.
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