Comparison of Day and Night Closed-loop With Faster-acting Insulin Aspart With Insulin Aspart

NCT03579615 | Completed

• 1 other identifier: R04695
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to determine whether automated closed-loop using faster-acting insulin aspart will improve glucose control and reduce the burden of hypoglycaemia over a 23-hour period compared to insulin aspart under conditions mimicking under-estimation of meal carbohydrate content or missed meal bolus. Faster-acting insulin aspart (FIASP) is a novel formulation of insulin aspart in which two additional excipients (L-arginine and Niacinamide) 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 closed-loop study has been performed to evaluate the benefit of faster-acting aspart over insulin aspart during closed-loop system use.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Time spent in the target glucose range

  Time spent in the target glucose range between 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on sensor glucose levels between the hours of 19:00 on day 1 and 18:00 hours on day 2 of the inpatient stay.

  23 hours

Secondary Outcomes (11)

• Time spent in the target glucose range within 4 hours of each meal

  4 hours

• Incremental area under the curve of sensor glucose level within 4 hours of each meal

  4 hours

• Time spent below target glucose

  23 hours

• Time spent above target glucose

  23 hours

• Average, coefficient of variation and standard deviation glucose levels

  23 hours

Study Arms (2)

FIASP + closed loop device

EXPERIMENTAL

Subjects randomised to FIASP and closed loop device will be invited to have blood samples taken at baseline, CGM training, competency assessment, and optimisation of treatment. This is followed by inpatient stay where patients will be using FIASP + closed loop intervention for 24 hours. Participants will be advised to change their usual insulin to the corresponding study visit insulin formulation, 24 hours prior to admission. (For example; if the participant is on insulin aspart, this will be changed to faster-acting aspart 24-hour prior to the admission for closed loop with faster-acting aspart and vice versa).

Device: FIASP + closed loop device

Insulin aspart (standard of care insulin) + closed loop device

ACTIVE COMPARATOR

Subjects randomised to insulin aspart (standard of care insulin) and closed loop device will be invited to have blood samples taken at baseline, CGM training, competency assessment, and optimisation of treatment. This is followed by inpatient stay where patients will be using insulin aspart (standard of care insulin) + closed loop intervention for 24 hours.Participants will be advised to change their usual insulin to the corresponding study visit insulin formulation, 24 hours prior to admission. (For example; if the participant is on insulin aspart, this will be changed to faster-acting aspart 24-hour prior to the admission for closed loop with faster-acting aspart and vice versa).

Device: Insulin aspart (standard of care insulin) + closed loop device

Interventions

FIASP + closed loop device DEVICE

Participants will be advised to change their usual insulin to the corresponding study visit insulin formulation, 24 hours prior to admission. (For example; if the participant is on insulin aspart, this will be changed to faster-acting aspart 24-hour prior to the admission for closed loop with faster-acting aspart and vice versa).

FIASP + closed loop device

Insulin aspart (standard of care insulin) + closed loop device DEVICE

Participants will be advised to maintain their usual insulin 24 hours prior to admission.

Insulin aspart (standard of care insulin) + closed loop device

Eligibility Criteria

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

You may qualify if:

• The subject is 18 years and older
• The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
• The subject will have been an insulin pump user for at least 3 months
• The subject is treated with any of the rapid acting insulin analogues
• The subject is willing to adhere to study procedures
• HbA1c ≥ 7.0% (53 mmol/mol) and ≤ 10 % (86mmol/mol) based on analysis from local laboratory or equivalent within 3 months prior to enrolment
• The subject is literate in English

You may not qualify if:

• \. 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. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, non-selective beta-blockers and MAO inhibitors etc.
• \. Known or suspected allergy against insulin 6. Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator 7. Total daily insulin dose \> 2 U/kg/day 8. Total daily insulin dose \< 10 U/day 9. Pregnancy, planned pregnancy, or breast feeding

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Manchester University Hospitals NHS Foundation Trust

Manchester, M13 WL, United Kingdom

Location

Related Publications (1)

• Thabit H, Mubita W, Rubio J, Karuppan M, Schofield J, Willinska ME, Hovorka R, Leelarathna L. Comparison of faster-acting aspart with insulin aspart under conditions mimicking underestimation or missed meal boluses in type 1 diabetes using closed-loop insulin delivery. Diabetes Obes Metab. 2023 Apr;25(4):1121-1124. doi: 10.1111/dom.14942. Epub 2022 Dec 27. No abstract available.

  PMID: 36514847 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: FIASP vs standard of care insulin
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: An open-label, single-centre, randomised, two-period, cross-over study

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: December 23, 2020
• Primary Completion: February 24, 2022
• Study Completion: August 1, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

GB (1)