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24/7 Closed-loop in Older Subjects With Type 1 Diabetes (DAN06)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04025762
Recruitment Status : Active, not recruiting
First Posted : July 19, 2019
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
Manchester University NHS Foundation Trust
University Hospital Birmingham NHS Foundation Trust
Medical University of Graz
Information provided by (Responsible Party):
Dr Roman Hovorka, University of Cambridge

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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Day and night hybrid closed loop control

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
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. HbA1c at the end of treatment period [ Time Frame: 16 weeks ]
  2. Time spent below target glucose (3.9mmol/l) (70mg/dl) based on CGM [ Time Frame: 16 weeks ]
  3. Time spent above target glucose (10.0 mmol/l) (180 mg/dl) based on CGM [ Time Frame: 16 weeks ]
  4. Average, standard deviation, and coefficient of variation of CGM glucose levels [ Time Frame: 16 weeks ]
  5. 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 ]
  6. Time with glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300mg/dl) [ Time Frame: 16 weeks ]
  7. Total, basal and bolus insulin dose [ Time Frame: 16 weeks ]
  8. 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 ]

Other Outcome Measures:
  1. Utility evaluation [ Time Frame: 16 weeks ]
    The frequency and duration of use of the closed-loop system at home.

  2. 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

  3. Cardiac arrythmia analysis [ Time Frame: 5-7 days ]
    Holter monitor data at the fourth month in the two treatment groups

  4. Sleep quality assessment [ Time Frame: 14 days ]
    Sleep quality assessment using data collected by Actiwatch



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 60 years and above
  2. Type 1 diabetes as defined by WHO for at least 1 year or confirmed C-peptide negative
  3. On insulin pump for at least 3 months with good knowledge of insulin self-adjustment
  4. Treated with one of the U-100 rapid acting insulin analogues only (insulin Aspart, Lispro, Faster insulin Aspart but not Glulisine)
  5. Willing to perform regular capillary blood glucose monitoring
  6. HbA1c ≤ 10% (86 mmol/mmol) based on analysis from central laboratory or equivalent
  7. Literate in English
  8. 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
  9. Willing to wear closed-loop system at home and at work place
  10. Willing to follow study specific instructions
  11. Willing to upload pump and CGM data at regular intervals
  12. Has access to WiFi

Exclusion Criteria:

  1. Non-type 1 diabetes mellitus
  2. Use of a closed-loop system within the last 30 days
  3. Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
  4. Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrolment
  5. Untreated coeliac disease, adrenal insufficiency or hypothyroidism
  6. Known or suspected allergy against insulin
  7. More than one episodes of severe hypoglycaemia as defined by American Diabetes Association in preceding 6 months
  8. Random C-peptide > 100pmol/l with concomitant plasma glucose >4 mmol/l (72 mg/dl)
  9. Lack of reliable telephone facility for contact
  10. Total daily insulin dose >/= 2 IU/kg/day
  11. Total daily insulin dose < 15 IU/day
  12. Severe visual impairment
  13. Severe hearing impairment
  14. Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
  15. 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)
  16. Subject is currently abusing illicit drugs
  17. Subject is currently abusing prescription drugs
  18. Subject is currently abusing alcohol
  19. Subject has elective surgery planned that requires general anaesthesia during the course of the study
  20. Subject is a shift worker with working hours between 10pm and 8am
  21. Subject has a sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
  22. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  23. Subject diagnosed with current eating disorder such as anorexia or bulimia
  24. Subject plans to use significant quantity of herbal preparations (use of over the counter herbal preparation for 30 consecutive days or longer period during the study) or significant quantity of vitamin supplements (four times the recommended daily allowance used for 30 consecutive days or longer period during the study) known to affect glucose metabolism and/or blood glucose levels during the course of their participation in the study
  25. Subject not proficient in English (UK), or German (Austria)

Information from the National Library of Medicine

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


Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Manchester Royal Infirmary
Manchester, United Kingdom
Sponsors and Collaborators
University of Cambridge
Manchester University NHS Foundation Trust
University Hospital Birmingham NHS Foundation Trust
Medical University of Graz
Investigators
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Principal Investigator: Roman Hovorka, PhD University of Cambridge
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Responsible Party: Dr Roman Hovorka, Chief Investigator, University of Cambridge
ClinicalTrials.gov Identifier: NCT04025762    
Other Study ID Numbers: DAN06
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases