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Multinational Home Use of Closed-Loop Control Is Safe and Effective
Stacey M Anderson1, Dan Raghinaru2, Jordan E Pinsker3
1University of Virginia, Charlottesville, VA.
Diabetes Care
|May 22, 2016
Summary
A wearable artificial pancreas system (Diabetes Assistant) effectively controlled glucose in type 1 diabetes patients. Both overnight and 24/7 closed-loop control reduced hypoglycemia and improved time in target range at home.
Area of Science:
- Endocrinology
- Biomedical Engineering
- Diabetes Technology
Background:
- Type 1 diabetes management requires continuous glucose monitoring and insulin delivery.
- Artificial pancreas systems aim to automate glucose control, reducing the burden on patients.
- Evaluating home-based closed-loop control systems is crucial for real-world efficacy.
Purpose of the Study:
- To assess the efficacy of a portable, wireless artificial pancreas (Diabetes Assistant) in type 1 diabetes patients.
- To compare overnight-only versus 24/7 closed-loop control (CLC) modes for glucose management at home.
- To evaluate safety and effectiveness of the Diabetes Assistant system.
Main Methods:
- A study involving 30 type 1 diabetes participants across six international clinical centers.
- Participants used sensor-augmented pump (SAP) therapy for 2 weeks, followed by 2 weeks of overnight-only CLC and 2 weeks of 24/7 CLC at home.
- Glucose control metrics during CLC were compared against the baseline SAP period.
Main Results:
- Overnight-only CLC significantly reduced hypoglycemia (1.1% vs. 3.0% time <70 mg/dL) and increased time in target range (75% vs. 61%) compared to SAP.
- 24/7 CLC also demonstrated significant improvements: reduced hypoglycemia (1.7% vs. 4.1%) and increased time in target range (73% vs. 65%).
- Both CLC modes improved glucose variability, with 24/7 CLC offering additional daytime hypoglycemia protection over overnight-only CLC.
Conclusions:
- The smartphone-based Diabetes Assistant (DiAs) system is safe and effective for home glucose control in type 1 diabetes.
- Both overnight-only and 24/7 CLC modes significantly improve glycemic control, reducing hypoglycemia and increasing time in range.
- 24/7 CLC provides enhanced glycemic control and hypoglycemia prevention compared to overnight-only CLC.
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