Dexcom Hybrid Closed Loop Insulin Pump Study in Type 1 Diabetes - Trial NCT05059860
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.
Study Focus
Tandem Control IQ Hybrid Closed Loop Insulin Delivery System
Observational
device
Sponsor & Location
NHS Lothian
Timeline & Enrollment
N/A
Oct 01, 2021
Nov 01, 2024
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
Data Source
ClinicalTrials.gov
NCT05059860
Device Trial