NCT04266379

Efficacy of Closed-loop Insulin Therapy in Adults Prone to Hypoglycemia

A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor and Pump Therapy in the Management of Type 1 Diabetes Prone to Hypoglycemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a RCT of 3 month at home comparing closed-loop control (CLC) system vs sensor and pump therapy (S\&P), with a 3-month extension phase, in Type 1 diabetic patient prone to hypoglycemia. After a 2-week run-in phase with blinded CGM, patients who spent 5% or more time below 70mg/dL will be eligible to continue. They will will be randomly assigned 2:1 to the use of closed-loop control (CLC) using Tandem Control-IQ vs S\&P for 3 months, which is the timing of the primary outcome for the RCT. After 3 months, the S\&P group will use CLC for up to 3 months and the CLC group will continue using CLC for up to 3 additional months.

Detailed description

This study is randomized controlled trial of 3 month at home closed-loop control (CLC) system vs sensor and pump therapy (S\&P), with a 3-month extension phase. The objective is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system in patients with type 1 diabetes prone to hypoglycemia. The CLC system will consist of Tandem Control-IQ Automated Insulin Delivery System (AIDS), including Tandem X2 insulin pump with embedded Control-IQ algorithm and Dexcom G6 CGM After consent is signed, eligibility will be assessed. All participants will initiate a run-in phase of 2 weeks of blinded Dexcom G6 CGM wear and personal insulin pump. Prior to overall initiation of the RCT, the time spent with CGM below 70 mg/dl during the run-in phase will be assessed. Only patients showing % time with CGM \<70 mg/dl of 5% or above can be randomized. Included patients who cannot be randomized will be replaced. Subsequent participants who show randomization criteria during the run-in phase will be randomly assigned 2:1 to the use of closed-loop control (CLC) using Tandem Control-IQ vs S\&P for 3 months, which is the timing of the primary outcome for the RCT. After 3 months, the S\&P group will use CLC for up to 3 months and the CLC group will continue using CLC for up to 3 additional months.

Conditions

• Type 1 Diabetes Mellitus With Hypoglycemia

Interventions

Type	Name	Description
DEVICE	Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions	Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
DEVICE	Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring	Insulin delivered subcutaneously by a pump and manage by the patient with the help of a CGM sensor

Timeline

• Start date: 2020-05-13
• Primary completion: 2022-11-03
• Completion: 2023-02-03
• First posted: 2020-02-12
• Last updated: 2021-12-15

Locations

2 sites across 1 country: France

Regulatory

• FDA-regulated device study