Automated insulin delivery using ultra-rapid acting insulin for type 1 diabetes
An Open-label, Single-centre, Randomised, Two-period, Cross-over Study to Assess the Efficacy and Safety of Automated Closed-loop Glucose Control in Adults With Type 1 Diabetes Comparing Ultra-fast Acting Insulin Lispro With Insulin Lispro
This study is testing if a new type of fast-acting insulin can help adults with type 1 diabetes better manage their blood sugar levels compared to the standard insulin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust Government |
| Locations | 1 site (Manchester) |
| Trial ID | NCT05660941 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of fully closed-loop insulin delivery using ultra-rapid acting insulin lispro compared to standard insulin lispro in adults with type 1 diabetes. Participants will undergo two 12-hour inpatient stays where their glucose levels will be managed by a closed-loop system. The study will involve a randomized crossover design, allowing each participant to experience both treatment conditions. The goal is to determine if the new formulation of insulin can improve glucose control, especially in scenarios where meal boluses are missed.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with type 1 diabetes who are currently using an insulin pump.
Not a fit: Patients with non-type 1 diabetes or those with significant complications related to diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better glucose management for patients with type 1 diabetes, reducing the risk of complications.
How similar studies have performed: While this specific approach is novel, previous studies have shown promise in closed-loop insulin delivery systems for diabetes management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Aged 18 years or older 2. Type 1 diabetes, as defined by WHO, for at least 1 year or confirmed C-peptide negative 3. An insulin pump user for at least 3 months 4. Treated with any of the rapid acting insulin analogues (Insulin aspart, faster acting aspart, insulin lispro, ultra-rapid acting lispro or insulin glulisine) 5. Willing to adhere to study procedures 6. HbA1c ≥ 6.5% (48 mmol/mol) and ≤ 10 % (86mmol/mol) based on analysis from local laboratory or equivalent within 36 months of enrolment or estimated HbA1c (GMI) based on sensor glucose data 7. Literate in English Exclusion Criteria: 1. Non-type 1 diabetes mellitus including those secondary to chronic disease 2. Any other physical or psychological disease likely to interfere with the normal conduct of the study 3. Untreated celiac disease or hypothyroidism 4. Clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator 5. Total daily insulin dose equal or more than 2 U/kg/day 6. Total daily insulin dose \< 10 U/day 7. Pregnancy, planned pregnancy, or breast feeding
Where this trial is running
Manchester
- Manchester University NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Hood Thabit, MD PhD
- Email: hood.thabit@mft.nhs.uk
- Phone: 01612766706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.