NCT05059860

Dexcom Hybrid Closed Loop Insulin Pump Study in Type 1 Diabetes

Name: Clinical Trial NCT05059860
Creator: NHS Lothian
Keywords: Type 1 Diabetes Mellitus, Tandem Control IQ Hybrid Closed Loop Insulin Delivery System, device, clinical trial

An Evaluation of the Tandem IQ Insulin Pump and DEXCOM G6 Continuous Blood Glucose Monitoring Hybrid Closed Loop Insulin Delivery System (Control-IQ) on Patient Wellbeing and Diabetes Control in Adults With Type 1 Diabetes

NHS Lothian·ClinicalTrials.gov·device·Device trialNot yet recruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Type 1 Diabetes Mellitus
Drug/Device/Intervention: Tandem Control IQ Hybrid Closed Loop Insulin Delivery System
Study type: Observational
Intervention type: device

Sponsor & location

Primary sponsor: NHS Lothian

Timeline & enrollment

Phase: N/A
Start date: Oct 01, 2021
End date: Nov 01, 2024
Enrollment: 30 participants

Primary outcome

HbA1c,Severe hypoglycaemia,Time in range,Time in hypoglycaemia,Time Control IQ system not in use

Summary

Treatment of Type 1 diabetes requires daily insulin therapy given by either multiple daily injections or by continuous infusion via a pump. The insulin dose is calculated taking into consideration blood glucose levels, food intake and activity levels, aiming to avoid high and low readings.  The Tandem t:slim X2™ insulin pump has recently become available in NHS Scotland and can link with the Dexcom G6 continuous glucose monitoring (CGM) system.  The Tandem Control IQ hybrid closed loop system is made up of the Tandem insulin pump communicating wirelessly with the Dexcom G6 CGM. The algorithm within the pump then automatically controls the background (basal) insulin infusion rate. Manually delivered bolus insulin is still required for meals. This system is designed to finely tune insulin delivery and increase the amount of time that glucose is in the target range, reducing hypoglycaemia and hyperglycaemia.  Insulin pumps are funded by NHS Scotland, but the Dexcom G6 continuous glucose monitoring system is not, so this hybrid closed loop system is not currently routinely available in NHS Scotland.  The purpose of this study is to gain experience of this system and investigate how effective and acceptable the hybrid closed loop system is for people in Scotland. Participants will be provided with the Dexcom G6 CGM device to link to their current pump to create the hybrid closed loop system for the duration of the study.  30 people with Type 1 diabetes who have been using the Tandem pump for at least one month will be invited to participate.  The study will include a screening visit, a 30 day run-in period, 52 week treatment period and 12 week follow-up period. Diabetes control will be measured using HbA1c and downloaded information from the hybrid closed loop system. Participants will also complete questionnaires and a reflective diary.

ICD-10 classifications

Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05059860
Type: Device Trial

About this record

Access comprehensive clinical trial information for NCT05059860 through Pure Global AI's free database. This phase not specified trial is sponsored by NHS Lothian and is currently Not yet recruiting. The study focuses on Type 1 Diabetes Mellitus. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.