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Dexcom Hybrid Closed Loop Insulin Pump Study in Type 1 Diabetes

NCT05059860 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Tandem Control IQ Hybrid Closed Loop Insulin Delivery System

The Tandem Control IQ hybrid closed loop insulin delivery system is made up of an externally worn Tandem insulin pump which communicates wirelessly to the Dexcom G6 CGM worn as a patch on the skin. The CGM measures glucose levels transmitting them into the computer within the pump. The computer then calculates how much insulin is required then dose delivery completes the cycle. The Control-IQ™ advanced technology adjusts insulin delivery to avoid glycaemic excursions, while still allowing the user to manually bolus at mealtimes.

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • NHS Lothian

    lead OTHER_GOV

Principal Investigators

  • John McKnight · NHS Lothian

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-09
Primary Completion
2025-05-23
Completion
2025-05-23

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05059860 on ClinicalTrials.gov