Clinical trial NCT02379299: DiaCon Dual-Hormone Closed-Loop Glucose Control
Official title: Dual-Hormone Closed-Loop Glucose Control in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Type 1 Diabetes
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
First posted: 2015-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of time with glucose values < 3.9 mmol/l as measured by Continuous Glucose Monitoring and Yellow Spring Instruments
timeFrame: Every 5 minutes for 33 hours (total duration of each study arm)
measure: Number of CHO interventions to treat hypoglycemia
timeFrame: 33 hours (total duration of each study arm)
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Signe Schmidt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: