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

Phase 1

• Conditions: Patients with type 1 diabetes; MedDRA version: 20.0Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependentSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-001631-31-DK
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-26
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

-Age = 18 years
-T1D = 2 years
-Insulin pump therapy = 1
-Currently using FiAsp® - insulin
-HbA1c = 8.5% (69 mmol/mol)

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
-Inability and willingness to comply with all protocol procedures, e.g. exercise, sleeping, blood sampling, and meal consumption
-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

Withdrawal criteria
-In case of pregnancy (or desire for pregnancy), female subjects are withdrawn
-Lack of compliance to any of the important study procedures in the discretion of the investigator
-Unacceptable adverse effects in the discretion of the investigator
-Withdrawal on participants request will be accepted at any time without further justification

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified