Status:
COMPLETED
24/7 Closed-loop in Older Subjects With Type 1 Diabetes
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Manchester University NHS Foundation Trust
University Hospital Birmingham NHS Foundation Trust
Conditions:
Type 1 Diabetes Mellitus
Hypoglycemia
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The main objective of this open-label, multi-centre, randomised, crossover design study is to determine whether automated day and night closed-loop insulin delivery for 16 weeks under free living cond...
Detailed Description
No study thus far has specifically evaluated use of closed-loop insulin delivery in older adults with type 1 diabetes. During our previous closed-loop studies, if there is a communication failure betw...
Eligibility Criteria
Inclusion
- Age 60 years and above
- Type 1 diabetes as defined by WHO for at least 1 year or confirmed C-peptide negative
- On insulin pump for at least 3 months with good knowledge of insulin self-adjustment
- Treated with one of the U-100 rapid acting insulin analogues only (insulin Aspart, Lispro, Faster insulin Aspart but not Glulisine)
- Willing to perform regular capillary blood glucose monitoring
- HbA1c ≤ 10% (86 mmol/mmol) based on analysis from central laboratory or equivalent
- Literate in English
- Having a care partner who is aware of the subject's location and is trained to administer intramuscular glucagon and able to seek emergency assistance
- Willing to wear closed-loop system at home and at work place
- Willing to follow study specific instructions
- Willing to upload pump and CGM data at regular intervals
- Has access to WiFi
Exclusion
- Non-type 1 diabetes mellitus
- Use of a closed-loop system within the last 30 days
- Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs) in the 3 months prior to enrolment or any use of SGLT2 inhibitors
- Untreated coeliac disease, adrenal insufficiency or hypothyroidism
- Known or suspected allergy against insulin
- More than one episodes of severe hypoglycaemia as defined by American Diabetes Association in preceding 6 months
- Random C-peptide \> 200pmol/l with concomitant plasma glucose \>4 mmol/l (72 mg/dl)
- Lack of reliable telephone facility for contact
- Total daily insulin dose \>/= 2 IU/kg/day
- Total daily insulin dose \< 15 IU/day
- Severe visual impairment
- Severe hearing impairment
- Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
- Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which could potentially be used for localisation of the glucose sensor)
- Subject is currently abusing illicit drugs
- Subject is currently abusing prescription drugs
- Subject is currently abusing alcohol
- Subject has elective surgery planned that requires general anaesthesia during the course of the study
- Subject is a shift worker with working hours between 10pm and 8am
- Subject has a sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
- Subject diagnosed with current eating disorder such as anorexia or bulimia
- Subject plans to use significant quantity of herbal preparations (use of over the counter herbal preparation for 30 consecutive days or longer period during the study) or significant quantity of vitamin supplements (four times the recommended daily allowance used for 30 consecutive days or longer period during the study) known to affect glucose metabolism and/or blood glucose levels during the course of their participation in the study
- Subject not proficient in English (UK), or German (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 :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04025762
Start Date
September 1 2019
End Date
August 20 2021
Last Update
December 6 2024
Active Locations (2)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
2
Manchester Royal Infirmary
Manchester, United Kingdom