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

  • STATUS
    Recruiting
  • days left to enroll
    49
  • participants needed
    22
  • sponsor
    Manchester University NHS Foundation Trust
Updated on 30 January 2021

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.

Description

This is an open-label, single-centre, two-period, randomised, cross over study. The study involves a screening visit to assess participant eligibility and two 24 hour in-patient stays at the clinical research facility during which day and night glucose levels will be controlled by the closed-loop system with either faster-acting insulin aspart or insulin aspart.

Up to 22 adults with type 1 diabetes and treated with continuous subcutaneous insulin infusion will be recruited, aiming for 16 completed participants. Recruitment will take place at Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, UK. Participants will attend the Manchester Clinical Research Facility (MCRF), Manchester, on two occasions. In random order, they will undergo two closed-loop study days using either faster-acting insulin aspart or insulin aspart. During the study days, the closed-loop control algorithm will automatically modulate d insulin infusion rate based on real-time subcutaneous glucose sensor measurements. Participants will receive standardised meals with half usual meal bolus for the evening meal and no meal bolus for lunch time meal during each study day.

Details
Condition Insulin dependent diabetes mellitus, Diabetes Mellitus, Type 1, type 1 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus
Treatment FIASP + closed loop device, Insulin aspart (standard of care insulin) + closed loop device
Clinical Study IdentifierNCT03579615
SponsorManchester University NHS Foundation Trust
Last Modified on30 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: iddm or type 1 diabetes or type 1 diabetes mellitus or diabetes type 1 or diabetes mellitus type 1 or type i diabetes mellitus or insulin-dependent di...?
Do you have any of these conditions: type i diabetes mellitus or Diabetes Mellitus, Type 1 or insulin-dependent diabetes or Insulin dependent diabetes mellitus or type 1 diabetes or diabe...?
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

Exclusion Criteria

\. 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. 5. 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
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