Automated Fully Closed-Loop Insulin Delivery in Type 1 Diabetes With Ultra-Rapid Lispro (ACOLYTE Study)

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Dec 13, 2022

Keywords

ClinConnect Summary

The ACOLYTE Study is examining whether a new type of insulin called ultra-rapid acting lispro (Lyumjev) can help better control blood sugar levels in adults with type 1 diabetes compared to standard insulin lispro. This study is particularly interesting because it uses a fully automated system that adjusts insulin delivery based on real-time blood sugar readings. Participants will spend two separate days in a clinical facility, where they will receive controlled meals and have their glucose levels monitored to see how well each insulin type works under similar conditions.

To be eligible for this trial, participants must be at least 18 years old, have been diagnosed with type 1 diabetes for at least a year, and have been using an insulin pump for three months or longer. They should also have specific blood sugar levels (HbA1c) and be able to understand English. During the study, participants can expect to be closely monitored, and their safety will be a priority, with assessments for any low or high blood sugar episodes. This trial is currently recruiting participants at the Manchester Royal Infirmary and aims to include around 26 adults to complete the study.

Gender

ALL

Eligibility 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