Automated blood glucose control with insulin and glucagon in patients with type 1 diabetes

Phase 1

Conditions: Patients with type 1 diabetes
MedDRA version: 17.1Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependentSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2014-003261-20-DK

Lead Sponsor: Hvidovre University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Age = 18 years
-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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Percentage of time with glucose values < 3.9 mmol/l as measured by CGM and YSI<br>Number of CHO interventions to treat hypoglycemia<br><br>;Timepoint(s) of evaluation of this end point: Evaluation is performed after completion of the second study session, i.e. after two times 33-hours

Secondary Outcome Measures