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

NCT05660941 | Unknown

• 1 other identifier: B01661
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to determine whether fully closed-loop insulin delivery using ultra-rapid acting insulin lispro will improve glucose control compared to standard lispro under conditions mimicking missed meal bolus. Ultra-rapid acting lispro (Lyumjev) is a novel formulation of insulin lispro in which two additional excipients (citrate and trepostinil) have been added, resulting in accelerated initial absorption and more than double the glucose lowering effect in the first 30 minutes after subcutaneous administration using insulin pump. To date, no randomised controlled trial involving fully closed-loop in type 1 diabetes has been performed to evaluate the benefit of Lyumjev over standard lispro. This is an open-label, single-centre, two-period, randomised, crossover study. The study involves two 12-hour in-patient stays at the clinical research facility during which glucose levels will be controlled by the Cambridge closed-loop system with either Lyumjev or standard lispro. Up to 26 adults with type 1 diabetes treated with insulin pump will be recruited at Manchester Royal Infirmary, aiming for 19 completed participants. During the study days, closed-loop will automatically modulate insulin infusion rate based on real-time glucose sensor measurements. Participants will receive standardised meals with no meal bolus for the lunch time meal during each study day. Primary outcome is the time spent in sensor glucose range (3.9-10.0mmol/l) between 11:00 - 17:00 hrs. Secondary outcomes are the time spent with glucose levels above and below target, and other sensor-based metrics. Safety evaluation comprises assessment of the frequency of hypo and hyperglycaemic episodes.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes; Type 1; Closed Loop; Insulin

Outcome Measures

Primary Outcomes (1)

• Time in range

  The primary outcome is time spent in the target glucose range (3.9 to 10.0 mmol/l) based on sensor glucose levels, between the hours of 11:00 and 17:00 hours, during inpatient stay

  6 hours

Secondary Outcomes (6)

• Area under curve

  4 hours

• Time below target

  6 Hours

• Time above target

  6 Hours

• Mean glucose and glycaemic variability

  6 hours

• Insulin dose

  6 hours

Study Arms (2)

Ultrarapid-acting Lispro

EXPERIMENTAL

ultrarapid-acting lispro delivered by hybrid closed loop system.

Drug: Lispro

Insulin Lispro

ACTIVE COMPARATOR

Insulin lispro delivered by hybrid closed loop system.

Drug: Lispro

Interventions

Lispro DRUG

Ultra rapid Lispro

Also known as: Lyumjev

Ultrarapid-acting Lispro

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• Non-type 1 diabetes mellitus including those secondary to chronic disease
• Any other physical or psychological disease likely to interfere with the normal conduct of the study
• Untreated celiac disease or hypothyroidism
• Clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
• Total daily insulin dose equal or more than 2 U/kg/day
• Total daily insulin dose \< 10 U/day
• Pregnancy, planned pregnancy, or breast feeding

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Hood Thabit, MD PhD

CONTACT

01612766706; hood.thabit@mft.nhs.uk

Mohammed Nazir, BSc

CONTACT

01612766706; mohammed.nazir@mft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: July 21, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

GB (1)