DAN06
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.
Sponsor study identifier
interventional
38
1 country
2
Study Start
September 1, 2019
Actual (reported)Primary Completion
August 20, 2021
Actual (reported)Study Completion
August 20, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 20, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 16, 2019
Actual (reported)July 19, 2019
Actual (reported)September 1, 2019
Actual (reported)August 20, 2021
Actual (reported)August 20, 2021
Actual (reported)December 6, 2024
Actual (reported)Proportion of Time Spent in the Target Sensor Glucose Range During the 16 Week Intervention Period (%)
Proportion of 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
HbA1c at the End of the 16 Week Intervention Period (mmol/Mol)
16 weeks
Proportion of Time Spent Below Target Glucose (3.9mmol/l) (70mg/dl) Based on CGM During the 16 Week Intervention Period (%)
16 weeks
Proportion of Time Spent Above Target Glucose (10.0 mmol/l) (180 mg/dl) Based on CGM During the 16 Week Intervention Period (%)
16 weeks
Average (mmol/L) of CGM Glucose Levels During the 16 Week Intervention Period
16 weeks
Proportion of Time With Glucose Levels < 3.5 mmol/l (63mg/dl) Based on CGM During the 16 Week Intervention Period (%)
16 weeks
The Proportion of Time of Use of the Closed-loop System at Home During the 16 Week Intervention Period (%)
16 weeks
Cardiac Arrythmia Analysis
5-7 days
Sleep Quality Assessment
14 days
The day and night hybrid closed-loop system (CamAPS FX) will consist of: * Dana RS insulin pump (Sooil) * G6 real-time CGM sensor (Dexcom) * An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Hybrid closed-loop system
Sensor augmented pump therapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Schneider-Utaka AK, Hanes S, Boughton CK, Hartnell S, Thabit H, Mubita WM, Draxlbauer K, Poettler T, Hayes J, Wilinska ME, Mader JK, Narendran P, Leelarathna L, Evans ML, Hovorka R, Hood KK. Patient-reported outcomes for older adults on CamAPS FX closed loop system. Diabet Med. 2023 Sep;40(9):e15126. doi: 10.1111/dme.15126. Epub 2023 May 23.
Boughton CK, Hartnell S, Thabit H, Mubita WM, Draxlbauer K, Poettler T, Wilinska ME, Hood KK, Mader JK, Narendran P, Leelarathna L, Evans ML, Hovorka R. Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study. Lancet Healthy Longev. 2022 Mar;3(3):e135-e142. doi: 10.1016/S2666-7568(22)00005-8. Epub 2022 Mar 7.
Roman Hovorka, PhD
University of Cambridge
38 participants (actual enrollment reported by the registry).
First Submitted
July 16, 2019
First Posted
July 19, 2019
Study Start
September 1, 2019
Closing the Loop in People with Type 1 Diabetes
Contact the study team to confirm eligibility.
Primary Completion
August 20, 2021
Actual (reported)Study Completion
August 20, 2021
Actual (reported)Last Updated
December 6, 2024
Results First Posted
December 6, 2024
Record last verified: 2024-12
Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication. To gain access, data requestors will need to sign a data access agreement. Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.
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Source: ClinicalTrials.gov.
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