Type 1 Diabetes Mellitus Clinical Trial
Official 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.
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.
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. ;
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 |
NCT02558491 -
Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
|
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 |