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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04025762
Other study ID # DAN06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date August 20, 2021

Study information

Verified date September 2021
Source University of Cambridge
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 between the algorithm device and the insulin pump, the pump is set to deliver pre-programmed basal insulin rates after about 30 to 60 minutes.The main objective of this 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. This is an open-label, multi-centre, randomised, crossover design study, involving a 4-6 week run-in period, followed by two 4 months study periods during which glucose levels will be controlled either by an automated closed-loop system or by sensor-augmented pump therapy in random order. A total of up to 42 adults (aiming for 36 completed subjects) aged 60 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 6 weeks of the first intervention period will be replaced. Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L (70 and 180mg/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 arrhythmia and objective sleep quality assessment will also be evaluated in this study.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date August 20, 2021
Est. primary completion date August 20, 2021
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. Age 60 years and above 2. Type 1 diabetes as defined by WHO for at least 1 year or confirmed C-peptide negative 3. On insulin pump for at least 3 months with good knowledge of insulin self-adjustment 4. Treated with one of the U-100 rapid acting insulin analogues only (insulin Aspart, Lispro, Faster insulin Aspart but not Glulisine) 5. Willing to perform regular capillary blood glucose monitoring 6. HbA1c = 10% (86 mmol/mmol) based on analysis from central laboratory or equivalent 7. Literate in English 8. 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 9. Willing to wear closed-loop system at home and at work place 10. Willing to follow study specific instructions 11. Willing to upload pump and CGM data at regular intervals 12. Has access to WiFi Exclusion Criteria: 1. Non-type 1 diabetes mellitus 2. Use of a closed-loop system within the last 30 days 3. Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results 4. 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 5. Untreated coeliac disease, adrenal insufficiency or hypothyroidism 6. Known or suspected allergy against insulin 7. More than one episodes of severe hypoglycaemia as defined by American Diabetes Association in preceding 6 months 8. Random C-peptide > 200pmol/l with concomitant plasma glucose >4 mmol/l (72 mg/dl) 9. Lack of reliable telephone facility for contact 10. Total daily insulin dose >/= 2 IU/kg/day 11. Total daily insulin dose < 15 IU/day 12. Severe visual impairment 13. Severe hearing impairment 14. Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement 15. 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) 16. Subject is currently abusing illicit drugs 17. Subject is currently abusing prescription drugs 18. Subject is currently abusing alcohol 19. Subject has elective surgery planned that requires general anaesthesia during the course of the study 20. Subject is a shift worker with working hours between 10pm and 8am 21. Subject has a sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening 22. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation 23. Subject diagnosed with current eating disorder such as anorexia or bulimia 24. 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 25. Subject not proficient in English (UK), or German (Austria) Additional exclusion criteria specific for Austria 1. Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). 2. Positive alcohol breath test. 3. 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.

Study Design


Intervention

Device:
Hybrid closed-loop system (CamAPS FX)
Hybrid closed-loop system
Sensor augmented pump therapy
Sensor augmented pump therapy

Locations

Country Name City State
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge
United Kingdom Manchester Royal Infirmary Manchester

Sponsors (4)

Lead Sponsor Collaborator
University of Cambridge Manchester University NHS Foundation Trust, Medical University of Graz, University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Utility evaluation The frequency and duration of use of the closed-loop system at home. 16 weeks
Other Human Factor assessment Cognitive, emotional, and behavioural characteristics of participating subjects and family members and their response to the closed-loop system and clinical trial will be assessed using validated surveys and focus groups 30 minutes
Other Cardiac arrythmia analysis Holter monitor data at the fourth month in the two treatment groups 5-7 days
Other Sleep quality assessment Sleep quality assessment using data collected by Actiwatch 14 days
Primary Time spent in the target sensor glucose range Time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on continuous glucose monitoring (CGM) 16 weeks
Secondary HbA1c at the end of treatment period 16 weeks
Secondary Time spent below target glucose (3.9mmol/l) (70mg/dl) based on CGM 16 weeks
Secondary Time spent above target glucose (10.0 mmol/l) (180 mg/dl) based on CGM 16 weeks
Secondary Average, standard deviation, and coefficient of variation of CGM glucose levels 16 weeks
Secondary Time with glucose levels < 3.5 mmol/l (63mg/dl) and < 3.0 mmol/l (54mg/dl) based on CGM 16 weeks
Secondary Time with glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300mg/dl) 16 weeks
Secondary Total, basal and bolus insulin dose 16 weeks
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