| 1 |
NCT00944619 |
Completed |
Closing the Loop in Adults With Type 1 Diabetes - Alcohol Consumption |
|
- Device: Closed loop
- Device: Conventional insulin pump delivery
|
Interventional |
Not Applicable |
- University of Cambridge
- Cambridge University Hospitals NHS Foundation Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of plasma glucose values in target (3.9-8.0 mmol/L)
- Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
- Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
- (and 8 more...)
|
12 |
All |
18 Years to 65 Years (Adult) |
NCT00944619 |
09/H0306/44 |
ANGELA02 |
September 2009 |
December 2009 |
December 2009 |
July 23, 2009 |
May 12, 2010 |
|
- Addenbrooke's Hospital
Cambridge, United Kingdom
|
| 2 |
NCT00910767 |
Completed |
Closing the Loop in Adults With Type 1 Diabetes |
|
- Device: Conventional insulin pump delivery
- Device: Closed loop
|
Interventional |
Not Applicable |
- University of Cambridge
- Cambridge University Hospitals NHS Foundation Trust
- Diabetes UK
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of plasma glucose values in target (3.9 - 8.0 mmol/L)
- Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
- Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
- (and 8 more...)
|
12 |
All |
18 Years to 65 Years (Adult) |
NCT00910767 |
08/H0308/297 |
ANGELA01 |
February 2009 |
July 2009 |
July 2009 |
June 1, 2009 |
September 17, 2009 |
|
- Addenbrooke's Hospital
Cambridge, United Kingdom
|
| 3 |
NCT01666028 |
Completed |
Short Term Closed-loop Glucose Control in Adults With Type 1 Diabetes |
|
- Device: FlorenceD or similar closed loop glucose control system
- Device: CSII with real-time CGM
|
Interventional |
Phase 2 |
- University of Cambridge
- Cambridge University Hospitals NHS Foundation Trust
- Profil Institut für Stoffwechselforschung GmbH
- Medical University of Graz
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM) adjusted for sensor error.
- Time spent above and below the target glucose (3.9 to 10.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM)
- Average and standard deviation glucose levels based on continuous subcutaneous glucose monitoring
- (and 5 more...)
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT01666028 |
AP@home02 |
AP@home02 |
November 2012 |
November 2013 |
November 2013 |
August 16, 2012 |
December 2, 2014 |
|
- Medical University of Graz
Graz, Austria - Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany - Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
|
| 4 |
NCT02129868 |
Completed |
Automated Closed-loop in Children and Adolescents With Type 1 Diabetes |
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Glucose Metabolism Disorders
- (and 2 more...)
|
- Device: Closed-loop (Android Closed-Loop platform)
|
Interventional |
Not Applicable |
- University of Cambridge
- Cambridge University Hospitals NHS Foundation Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time spent with plasma glucose concentration in the target glucose range from 3.9 to 8.0 mmol/l.
- Time spent with plasma glucose concentration below the target range (<3.9mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
- Time spent with plasma glucose concentration above the target range (>8mmol/L) between 21:30 on Day 1 and 07:30 on Day 2 (10 hours).
- (and 5 more...)
|
13 |
All |
6 Years to 18 Years (Child, Adult) |
NCT02129868 |
APCam09 |
APCam09 |
April 2014 |
April 2015 |
April 2015 |
May 2, 2014 |
March 3, 2017 |
|
- University of Cambridge
Cambridge, United Kingdom
|
| 5 |
NCT01961622 |
Completed |
Closing the Loop in Adults With Sub-optimally Controlled Type 1 Diabetes Under Free Living Conditions |
|
- Device: Florence D2A or similar closed loop glucose control system
- Device: CSII with real-time CGM
|
Interventional |
Not Applicable |
- University of Cambridge
- Profil Institut für Stoffwechselforschung GmbH
- Medical University of Graz
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring
- HbA1c
- Insulin dose
- (and 5 more...)
|
33 |
All |
18 Years and older (Adult, Senior) |
NCT01961622 |
AP@home04 |
AP@home04 |
April 2014 |
May 2015 |
May 2015 |
October 11, 2013 |
June 8, 2015 |
|
- Medical University of Graz
Graz, Austria - Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany - University of Cambridge
Cambridge, United Kingdom
|
| 6 |
NCT01778348 |
Completed |
Closing the Loop in Children and Adolescents With Type 1 Diabetes in the Home Setting |
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Glucose Metabolism Disorders
- (and 2 more...)
|
- Device: Overnight closed-loop
- Device: Real-time CGM alone
|
Interventional |
Phase 2 |
- University of Cambridge
- Cambridge University Hospitals NHS Foundation Trust
- University College London Hospitals
- The Leeds Teaching Hospitals NHS Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time spent overnight in the target glucose range (3.9 to 8.0 mmol/l), as assessed by adjusted continuous subcutaneous glucose monitoring (CGM)
- The proportion of nights when glucose levels drop below 3.5 mmol/l for 20 minutes or longer, as recorded by CGM
- Time spent above and below the target glucose (3.9 to 8.0 mmol/l) based on CGM.
- (and 10 more...)
|
29 |
All |
6 Years to 18 Years (Child, Adult) |
NCT01778348 |
APCam08 |
APCam08 |
December 2013 |
March 2015 |
May 2015 |
January 29, 2013 |
March 3, 2017 |
|
- University of Cambridge
Cambridge, United Kingdom - Leeds Teaching Hospitals
Leeds, United Kingdom - University College London Hospital
London, United Kingdom
|
| 7 |
NCT01873066 |
Completed |
Closing the Loop 24/7 in Adolescents With Type 1 Diabetes |
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Glucose Metabolism Disorders
- Endocrine System Diseases
|
- Device: Closed-loop system
- Device: real-time CGM
|
Interventional |
Not Applicable |
- University of Cambridge
- Cambridge University Hospitals NHS Foundation Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The proportion of time spent in the target glucose range from 3.9 to 10.0 mmol/l based on CGM
- The proportion of time spent above and below the target glucose (3.9 to 10.0 mmol/l) based on CGM.
- The proportion of time with glucose levels < 3.5 mmol/l and <2.8 mmol/l based on CGM
- The proportion of time with glucose levels in significant hyperglycaemia, as based on CGM (glucose levels > 16.7 mmol/l)
|
24 |
All |
10 Years to 18 Years (Child, Adult) |
NCT01873066 |
DAN04 |
DAN04 |
August 28, 2014 |
July 31, 2015 |
January 1, 2016 |
June 7, 2013 |
March 3, 2017 |
|
- University of Cambridge
Cambridge, United Kingdom
|
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