Status:
COMPLETED
Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Technical University of Denmark
University of Copenhagen
Conditions:
Type 1 Diabetes
Hypoglycemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Despite recent pharmacological and technological advantages, hypoglycemia remains to be the key limiting factor in achieving optimal glycemic control in people with type 1 diabetes. State-of-the-art t...
Detailed Description
Rationale: We hypothesize that our newly developed dual-hormone insulin-glucagon closed-loop system (DCL) is safe, efficient and superior to our single-hormone insulin-only closed-loop system (SCL). T...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age ≥ 18 years
- T1D ≥ 2 years
- Insulin pump therapy ≥ 1
- Currently treated with FiAsp® - insulin
- HbA1c ≤ 8.5% (69 mmol/mol) 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- In case of pregnancy (or desire for pregnancy), female subjects are withdrawn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
- Patients who complete or withdraw from the study continue their usual quarterly follow-up visits at the diabetes clinic. Withdrawal does not affect their statutory patient rights.
Exclusion
Key Trial Info
Start Date :
July 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04053712
Start Date
July 16 2019
End Date
March 19 2021
Last Update
August 18 2022
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark