24/7 Closed-loop in Older Subjects With Type 1 Diabetes (DAN06)
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|ClinicalTrials.gov Identifier: NCT04025762|
Recruitment Status : Active, not recruiting
First Posted : July 19, 2019
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Hypoglycemia Arrythmia||Device: Hybrid closed-loop system (CamAPS FX) Device: Sensor augmented pump therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||An open-label, multi-centre randomised, two-period crossover study comparing day and night automated closed-loop glucose control with sensor-augmented pump therapy.|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Day and night hybrid closed loop control
The day and night hybrid closed-loop system (CamAPS FX) will consist of:
Device: Hybrid closed-loop system (CamAPS FX)
Hybrid closed-loop system
Active Comparator: Sensor augmented pump therapy
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Device: Sensor augmented pump therapy
Sensor augmented pump therapy
- Time spent in the target sensor glucose range [ Time Frame: 16 weeks ]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)
- HbA1c at the end of treatment period [ Time Frame: 16 weeks ]
- Time spent below target glucose (3.9mmol/l) (70mg/dl) based on CGM [ Time Frame: 16 weeks ]
- Time spent above target glucose (10.0 mmol/l) (180 mg/dl) based on CGM [ Time Frame: 16 weeks ]
- Average, standard deviation, and coefficient of variation of CGM glucose levels [ Time Frame: 16 weeks ]
- Time with glucose levels < 3.5 mmol/l (63mg/dl), < 3.0 mmol/l (54mg/dl), and <2.8 mmol/l (50mg/dl) based on CGM [ Time Frame: 16 weeks ]
- Time with glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300mg/dl) [ Time Frame: 16 weeks ]
- Total, basal and bolus insulin dose [ Time Frame: 16 weeks ]
- Area under the curve (AUC) of glucose below 3.5 mmol/l (63mg/dl) and below 3.0 mmol/l (54mg/dl) [ Time Frame: 16 weeks ]
- Utility evaluation [ Time Frame: 16 weeks ]The frequency and duration of use of the closed-loop system at home.
- Human Factor assessment [ Time Frame: 30 minutes ]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
- Cardiac arrythmia analysis [ Time Frame: 5-7 days ]Holter monitor data at the fourth month in the two treatment groups
- Sleep quality assessment [ Time Frame: 14 days ]Sleep quality assessment using data collected by Actiwatch
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025762
|Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, United Kingdom, CB2 0QQ|
|Manchester Royal Infirmary|
|Manchester, United Kingdom|
|Principal Investigator:||Roman Hovorka, PhD||University of Cambridge|