DiaCon Dual-Hormone Closed-Loop Glucose Control
Primary Purpose
Type 1 Diabetes
Status
Withdrawn
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
DiaCon dual-hormone closed-loop glucose control algorithm
DiaCon single-hormone closed-loop glucose control algorithm
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- T1D ≥ 2 years
- Insulin pump therapy with rapid-acting analog insulin ≥ 1 year
- HbA1c ≤ 8.5% (69 mmol/mol)
- Ability and willingness to comply with all protocol procedures
Exclusion Criteria:
- Pregnancy or nursing
- Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
- Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l)
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation
- History of coronary artery disease or congestive heart failure
- Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia
- Allergy to glucagon or lactose
- Pheochromocytoma
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Single-hormone closed-loop control
Dual-hormone closed-loop control
Arm Description
Closed-loop glucose control by use of insulin only by use of DiaCon single-hormone closed-loop glucose control algorithm
Closed-loop glucose control by use of insulin and glucagon by use of DiaCon dual-hormone closed-loop glucose control algorithm
Outcomes
Primary Outcome Measures
Percentage of time with glucose values < 3.9 mmol/l as measured by Continuous Glucose Monitoring and Yellow Spring Instruments
Number of CHO interventions to treat hypoglycemia
Secondary Outcome Measures
Full Information
NCT ID
NCT02379299
First Posted
February 27, 2015
Last Updated
August 8, 2017
Sponsor
Hvidovre University Hospital
Collaborators
Technical University of Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02379299
Brief Title
DiaCon Dual-Hormone Closed-Loop Glucose Control
Official Title
Dual-Hormone Closed-Loop Glucose Control in Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
July 22, 2017 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Technical University of Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The ultimate T1D treatment tool is a closed-loop glucose control system, i.e. a fully automated system for intensive insulin treatment. Such system will ease the burden of constant treatment decision-making and at the same time it has the potential to safely intensify insulin therapy such that more patients can reach treatment goals. Currently, no off-the-shelf closed-loop system exists but research efforts in this field have been intensified and resulted in great progress in recent years. Most closed-loop systems consist of an insulin pump, a CGM, and a control algorithm residing on a mobile computer that continuously (every 5-15 min) computes the optimal insulin dosage from the CGM values. For daytime blood glucose control, however, we believe that the system needs to be further advanced. Consequently, we have extended our single-hormone closed-loop system such that it now includes a second pump for glucagon delivery and correspondingly we have further developed our control algorithm to compute both insulin and glucagon dosages.
We hypothesize that we have developed a safe and effective dual-hormone closed-loop system for patients with type 1 diabetes and that this system is superior to single-hormone closed-loop therapy. The aims of this two-phase project are to 1) demonstrate proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-hormone closed-loop control
Arm Type
Active Comparator
Arm Description
Closed-loop glucose control by use of insulin only by use of DiaCon single-hormone closed-loop glucose control algorithm
Arm Title
Dual-hormone closed-loop control
Arm Type
Experimental
Arm Description
Closed-loop glucose control by use of insulin and glucagon by use of DiaCon dual-hormone closed-loop glucose control algorithm
Intervention Type
Device
Intervention Name(s)
DiaCon dual-hormone closed-loop glucose control algorithm
Intervention Description
Dual-hormone closed-loop glucose control
Intervention Type
Device
Intervention Name(s)
DiaCon single-hormone closed-loop glucose control algorithm
Intervention Description
Single-hormone closed-loop glucose control
Primary Outcome Measure Information:
Title
Percentage of time with glucose values < 3.9 mmol/l as measured by Continuous Glucose Monitoring and Yellow Spring Instruments
Time Frame
Every 5 minutes for 33 hours (total duration of each study arm)
Title
Number of CHO interventions to treat hypoglycemia
Time Frame
33 hours (total duration of each study arm)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
T1D ≥ 2 years
Insulin pump therapy with rapid-acting analog insulin ≥ 1 year
HbA1c ≤ 8.5% (69 mmol/mol)
Ability and willingness to comply with all protocol procedures
Exclusion Criteria:
Pregnancy or nursing
Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l)
Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation
History of coronary artery disease or congestive heart failure
Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia
Allergy to glucagon or lactose
Pheochromocytoma
Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe Schmidt, MD, PhD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
DiaCon Dual-Hormone Closed-Loop Glucose Control
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