DiaCon Dual-Hormone Closed-Loop Glucose Control

Type 1 Diabetes Clinical Trial

Official title:

Dual-Hormone Closed-Loop Glucose Control in Type 1 Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02379299
• Other study ID #: DHCL2014
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: February 27, 2015
• Last updated: August 8, 2017

Study information

• Verified date: August 2016
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• DiaCon dual-hormone closed-loop glucose control algorithm
Dual-hormone closed-loop glucose control
• DiaCon single-hormone closed-loop glucose control algorithm
Single-hormone closed-loop glucose control

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time with glucose values < 3.9 mmol/l as measured by Continuous Glucose Monitoring and Yellow Spring Instruments		Every 5 minutes for 33 hours (total duration of each study arm)
Primary	Number of CHO interventions to treat hypoglycemia		33 hours (total duration of each study arm)