24/7 Closed-loop in Older Subjects With Type 1 Diabetes (NCT04025762) | Clinical Trial Compass
CompletedNot Applicable
24/7 Closed-loop in Older Subjects With Type 1 Diabetes
United Kingdom38 participantsStarted 2019-09-01
Plain-language 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 conditions is safer and more efficacious compared to sensor augmented insulin pump therapy in older adults with type 1 diabetes. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L (70 and 180 mg/dl) as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of human factor assessments, cardiac arrhythmias and objective sleep quality assessment will also be evaluated in this study.
Who can participate
Age range60 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Non-type 1 diabetes mellitus
✕. Use of a closed-loop system within the last 30 days
What they're measuring
1
Proportion of Time Spent in the Target Sensor Glucose Range During the 16 Week Intervention Period (%)
✕. 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)