DiaCon Dual-Hormone Closed-Loop Glucose Control

NCT ID: NCT02379299

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single-hormone closed-loop control

Closed-loop glucose control by use of insulin only by use of DiaCon single-hormone closed-loop glucose control algorithm

Group Type: ACTIVE_COMPARATOR

DiaCon single-hormone closed-loop glucose control algorithm

Intervention Type: DEVICE

Single-hormone closed-loop glucose control

Dual-hormone closed-loop control

Closed-loop glucose control by use of insulin and glucagon by use of DiaCon dual-hormone closed-loop glucose control algorithm

Group Type: EXPERIMENTAL

DiaCon dual-hormone closed-loop glucose control algorithm

Intervention Type: DEVICE

Dual-hormone closed-loop glucose control

Interventions

DiaCon dual-hormone closed-loop glucose control algorithm

Dual-hormone closed-loop glucose control

Intervention Type: DEVICE

DiaCon single-hormone closed-loop glucose control algorithm

Single-hormone closed-loop glucose control

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Denmark

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Signe Schmidt

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Signe Schmidt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Hvidovre University Hospital

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

DHCL2014

Identifier Type: -

Identifier Source: org_study_id