NCT05653050Completed
Closing the Loop in People with Type 1 Diabetes
An Open-label, Multi-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of Closed-loop Glucose Control Compared to Standard Insulin Pump Therapy Combined with Continuous Glucose Monitoring in Adolescents with Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 6 Dec 2024
Brief summary (registry, in English)
The main objective of this study is to determine whether home use of fully closed-loop glucose control applying age-approved ultra-rapid insulin (Phase 2) is superior to standard insulin pump therapy with continuous glucose monitoring (CGM) in adolescents with type 1 diabetes on insulin pump therapy with sub-optimal glycaemic control (HbA1c ≥ 7.5% \[Phase 2\]). This is an open-label, multi-centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using age-approved ultra-rapid insulin or by participants' usual insulin pump therapy with continuous glucose monitoring in random order. A total of up to 30 adolescents (aiming for 24 completed participants) with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods. Participants will receive appropriate training in the safe use of the closed-loop devices. Participants will have access to the study team during the home study phase with 24/7 telephone support. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM over the 8 week period. Secondary outcomes are HbA1c, time spent with glucose levels above and below target as recorded by CGM, and other CGM-based metrics in addition to insulin requirements. Safety evaluation comprises severe hypoglycaemic episodes, diabetic ketoacidosis (DKA) events and other adverse and serious adverse events.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 9 Nov 2022
- Start date
- 20 Feb 2023
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- University of Cambridge
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05653050
What you commit to
- Study type: Interventional
- Participants enrolled: 26
- From 20 Feb 2023 to the primary completion date, 30 Sept 2024
- 4 sites 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 physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- Known or suspected allergy against insulin
- Severe visual impairment
- Severe hearing impairment
Other
- Total daily insulin dose more than or equal to 2 IU/kg/day
- Use of a closed-loop system within the past 30 days
- Participant is pregnant or breast feeding or planning pregnancy within next 12 months
- Lack of reliable telephone facility for contact
- Participant not proficient in English
Who the study is looking for
- The participant has type 1 diabetes as defined by WHO for at least 1 year
- The participant is aged 13 to 19 years (inclusive) (Phase 2)
- The participant will have been on an insulin pump for at least 3 months with good knowledge of insulin self-adjustment
- The participant is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro, ultra-rapid Lispro insulin or Insulin Glulisine) 6. HbA1c ≥7.5% (58mmol/mol) based on analysis from local laboratory 7. The participant is willing to wear closed-loop devices 8. The participant is willing to follow study specific instructions 9. Female participants of child bearing age must have a negative urine-HCG pregnancy test at screening and should be using effective contraception if sexually active.
Age in the registry: 13 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Manchester Royal Infirmary Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Norfolk and Norwich University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
Related publications
- Lived experience of fully closed-loop insulin delivery in adolescents with type 1 diabetes and HbA1c above target.Diabetes Res Clin Pract · 2026 · PMID 41478508
This page is information, not medical advice. Discuss any trial with your doctor.