Status:
COMPLETED
Closing the Loop in Adults With Type 1 Diabetes Under Free Living Conditions
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Manchester University NHS Foundation Trust
Insel Gruppe AG, University Hospital Bern
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of this study is to determine whether home use of day and night closed loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) is non-inferior to h...
Detailed Description
Purpose of clinical trial The purpose is to determine whether home use of day and night closed loop applying faster insulin aspart is not inferior to home use of closed loop applying standard insulin ...
Eligibility Criteria
Inclusion
- The subject has type 1 diabetes as defined by WHO
- The subject is 18 years of age or older
- The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting
- The subject is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro or Insulin Glulisine)
- HbA1c \<10% (86mmol/mol) for phase 3, based on analysis from central laboratory or equivalent
- The subject is willing to perform regular finger-prick blood glucose monitoring, with at least 2 measurements per day
- The subject is willing to wear closed-loop system at home and at work place
- The subject is willing to follow study specific instructions including the use of bolus calculator for all meals / snacks
- The subject is willing to upload pump and CGM data at regular intervals
- Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening.
Exclusion
- Non-type 1 diabetes mellitus
- Subjects who are living alone
- Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
- Known or suspected allergy against insulin or previous reaction to FiAsp
- Subjects with clinically significant nephropathy (eGFR \< 45ml/min), neuropathy or active retinopathy (defined as presence of maculopathy or more than background diabetic retinopathy changes) as judged by the investigator
- More than one episode of severe hypoglycaemia as defined by American Diabetes Association (42) in preceding 12 months (Severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions including episodes of hypoglycaemia severe enough to cause unconsciousness, seizures or attendance at hospital.)
- Total daily insulin dose \> 2 IU/kg/day
- Subject is pregnant or breast feeding or planning pregnancy within next 10 months
- Severe visual impairment
- Severe hearing impairment
- Lack of reliable telephone facility for contact
- Subject not proficient in English (UK), French (Switzerland) or German (Germany, Switzerland and Austria)
- Additional exclusion criteria specific for Austria
- Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol breath test.
- Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.
Key Trial Info
Start Date :
August 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04055480
Start Date
August 10 2019
End Date
August 30 2020
Last Update
September 2 2020
Active Locations (4)
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1
Medical University of Graz
Graz, Austria
2
Inselspital, Bern University Hospital
Bern, Switzerland
3
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
4
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom