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NCT05059860Completed

Dexcom Hybrid Closed Loop Insulin Pump Study in Type 1 Diabetes

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

Source: ClinicalTrials.gov · Last updated 18 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
30 (actual)
First submitted
8 Sept 2021
Start date
Jun 2023
Primary completion date
May 2025
Lead sponsor
NHS Lothian
NCT number
NCT05059860

What you commit to

  • Study type: Observational
  • Participants enrolled: 30
  • From Jun 2023 to the primary completion date, May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any disorder which, in the investigators' opinion might jeopardise the patient's safety or compliance with the protocol

Lab values

  • Severe renal impairment (eGFR \<30ml/min)

Other

  • Pregnant or planning pregnancy
  • Life expectancy less than one year
  • Weight \<25kg
  • Patients prescribed hydroxycarbamide

Who the study is looking for

  • Clinical diagnosis of Type 1 diabetes
  • Established on the Tandem pump for at least 1 month, using novorapid or humalog insulin
  • HbA1c 40-90 mmol/mol inclusive within the previous 30 days or taken at screening
  • Total daily dose of insulin 10-100 units
  • Willing to attend study visits and complete all study assessments
  • Able to give informed consent

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Professor John McKnight
Coordinator of this site? Confirm its status
EdinburghUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.