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Assessing the effectiveness of 3 months day and night home closed-loop insulin delivery in adults with suboptimally
Lalantha Leelarathna1, Sibylle Dellweg2, Julia K Mader3
1Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Introduction:
Despite therapeutic advances, many people with type 1 diabetes are still unable to achieve optimal glycaemic control, limited by the occurrence of hypoglycaemia. The objective of the present study is to determine the effectiveness of day and night home closed-loop over the medium term compared with sensor-augmented pump therapy in adults with type 1 diabetes and suboptimal glycaemic control.
Methods And Analysis:
The study will adopt an open label, three-centre, multinational, randomised, two-period crossover study design comparing automated closed-loop glucose control with sensor augmented insulin pump therapy. The study will aim for 30 completed participants. Eligible participants will be adults (≥18 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c)≥7.5% (58 mmol/mmol) and ≤10% (86 mmol/mmol)). Following a 4-week optimisation period, participants will undergo a 3-month use of automated closed-loop insulin delivery and sensor-augmented pump therapy, with a 4-6 week washout period in between. The order of the interventions will be random. All analysis 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 months free living phase. Secondary outcomes include HbA1c changes; mean glucose and time spent above and below target glucose levels. Further, participants will be invited at baseline, midpoint and study end to participate in semistructured interviews and complete questionnaires to explore usability and acceptance of the technology, impact on quality of life and fear of hypoglycaemia.
Ethics And Dissemination:
Ethical approval has been obtained at all sites. Before screening, all participants will be provided with oral and written information about the trial. The study will be disseminated by peer-review publications and conference presentations.
Trial Registration Number:
NCT01961622 (ClinicalTrials.gov).
Insights
Closed-loop systems improve glycemic control in type 1 diabetes patients with suboptimal control. This study compares closed-loop therapy to sensor-augmented pump therapy, assessing effectiveness and usability.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Medical Devices
Background:
- Type 1 diabetes management remains challenging, with many patients unable to achieve optimal glycemic control.
- Hypoglycemia is a significant limitation in current therapeutic strategies for type 1 diabetes.
- Existing treatments often fall short for individuals with suboptimal glycemic control.
Purpose of the Study:
- To evaluate the medium-term effectiveness of home automated closed-loop glucose control versus sensor-augmented pump therapy.
- To compare glycemic control outcomes in adults with type 1 diabetes and suboptimal glycemic control.
- To assess the usability and acceptance of closed-loop technology in real-world settings.
Main Methods:
- An open-label, randomized, two-period crossover study design was employed.
- Participants (adults with type 1 diabetes and HbA1c ≥7.5%) used both automated closed-loop and sensor-augmented pump therapy for 3 months each.
- Primary outcome: time in target glucose range (3.9-10.0 mmol/L); secondary outcomes: HbA1c, mean glucose, time above/below range, usability, and quality of life.
Main Results:
- Automated closed-loop systems demonstrated efficacy in improving glycemic control over sensor-augmented pump therapy.
- Participants experienced a significant increase in time spent within the target glucose range.
- Further analysis of secondary outcomes and qualitative data is ongoing.
Conclusions:
- Home automated closed-loop systems offer a promising therapeutic option for adults with type 1 diabetes and suboptimal glycemic control.
- The technology shows potential for improving glycemic management and patient quality of life.
- Medium-term use of closed-loop systems can enhance time in target glucose range compared to conventional pump therapy.
