24/7 Closed-loop in Older Subjects With Type 1 Diabetes
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.
1 other identifier
interventional
38
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2021
CompletedResults Posted
Study results publicly available
December 6, 2024
CompletedDecember 6, 2024
December 1, 2024
2 years
July 16, 2019
February 16, 2023
December 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Other Outcomes (3)
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
Study Arms (2)
Day and night hybrid closed loop control
EXPERIMENTALThe 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
Sensor augmented pump therapy
ACTIVE COMPARATORThe comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)
Interventions
Hybrid closed-loop system
Eligibility Criteria
You may qualify if:
- Age 60 years and above
- Type 1 diabetes as defined by WHO for at least 1 year or confirmed C-peptide negative
- On insulin pump for at least 3 months with good knowledge of insulin self-adjustment
- Treated with one of the U-100 rapid acting insulin analogues only (insulin Aspart, Lispro, Faster insulin Aspart but not Glulisine)
- Willing to perform regular capillary blood glucose monitoring
- HbA1c ≤ 10% (86 mmol/mmol) based on analysis from central laboratory or equivalent
- Literate in English
- 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
- Willing to wear closed-loop system at home and at work place
- Willing to follow study specific instructions
- Willing to upload pump and CGM data at regular intervals
- Has access to WiFi
You may not qualify if:
- Non-type 1 diabetes mellitus
- Use of a closed-loop system within the last 30 days
- Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- 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
- Untreated coeliac disease, adrenal insufficiency or hypothyroidism
- Known or suspected allergy against insulin
- More than one episodes of severe hypoglycaemia as defined by American Diabetes Association in preceding 6 months
- Random C-peptide \> 200pmol/l with concomitant plasma glucose \>4 mmol/l (72 mg/dl)
- Lack of reliable telephone facility for contact
- Total daily insulin dose \>/= 2 IU/kg/day
- Total daily insulin dose \< 15 IU/day
- Severe visual impairment
- Severe hearing impairment
- Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
- 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)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cambridgelead
- Manchester University NHS Foundation Trustcollaborator
- University Hospital Birmingham NHS Foundation Trustcollaborator
- Medical University of Grazcollaborator
Study Sites (2)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Related Publications (2)
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.
PMID: 37171467DERIVEDBoughton 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.
PMID: 35359882DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Charlotte Boughton
- Organization
- University of Cambridge
Study Officials
- PRINCIPAL INVESTIGATOR
Roman Hovorka, PhD
University of Cambridge
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator
Study Record Dates
First Submitted
July 16, 2019
First Posted
July 19, 2019
Study Start
September 1, 2019
Primary Completion
August 20, 2021
Study Completion
August 20, 2021
Last Updated
December 6, 2024
Results First Posted
December 6, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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.