NCT02985866

The International Diabetes Closed Loop (iDCL) Trial: Protocol 1

Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.

Detailed description

The protocol is a 3-month parallel group multi-center randomized trial designed to compare Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP). Approximately 126 subjects will be entered into the randomized trial at approximately seven clinical sites in the United States, such that at least 110 subjects complete the randomized trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of randomizing 126 subjects. In order to have a broad range of glycemic control among the subjects, a study goal will be to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c \< 7.5%.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Artificial Pancreas	Use of CTR at home for 3 months
OTHER	Sensor Augmented Therapy	Use of personal pump with study CGM \& glucometer at home for 3 months

Timeline

• Start date: 2017-10-27
• Primary completion: 2018-09-04
• Completion: 2018-09-04
• First posted: 2016-12-07
• Last updated: 2022-12-05
• Results posted: 2022-12-05

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study