Type 1 Diabetes Mellitus Clinical Trial
— DAN06Official title:
An Open-label, Multi-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of 16 Week Day and Night Automated Closed-loop Glucose Control Under Free Living Conditions Compared to Sensor Augmented Insulin Pump Therapy in Older Adults With Type 1 Diabetes.
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 |
Verified date | September 2021 |
Source | University of Cambridge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | |
United Kingdom | Manchester Royal Infirmary | Manchester |
Lead Sponsor | Collaborator |
---|---|
University of Cambridge | Manchester University NHS Foundation Trust, Medical University of Graz, University Hospital Birmingham NHS Foundation Trust |
United Kingdom,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04476472 -
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
|
N/A | |
Completed |
NCT03635437 -
Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes
|
Phase 1/Phase 2 | |
Completed |
NCT04909580 -
Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT00679042 -
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
|
Phase 3 | |
Completed |
NCT03293082 -
Preschool CGM Use and Glucose Variability in Type 1 Diabetes
|
N/A | |
Completed |
NCT04016662 -
Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)
|
Phase 4 | |
Completed |
NCT02527265 -
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
|
Phase 2 | |
Completed |
NCT03738865 -
G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
|
Phase 3 | |
Completed |
NCT03240432 -
Wireless Innovation for Seniors With Diabetes Mellitus
|
N/A | |
Completed |
NCT03168867 -
Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
|
N/A | |
Completed |
NCT03674281 -
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
|
N/A | |
Completed |
NCT03669770 -
Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
|
||
Recruiting |
NCT03682640 -
Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
|
Phase 2 | |
Recruiting |
NCT04096794 -
Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
|
||
Completed |
NCT02882737 -
The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
|
N/A | |
Recruiting |
NCT02745808 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Completed |
NCT02596204 -
Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
|
N/A | |
Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Withdrawn |
NCT02518022 -
How to be Safe With Alcoholic Drinks in Diabetes
|
N/A | |
Completed |
NCT02562313 -
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
|
Phase 1 |