Status:
COMPLETED
Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Type 1 Diabetes
Hypoglycemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose dasiglucagon administered via a multi-dose reusable pen injector in preventing and treati...
Detailed Description
A randomized, open-label, two-arm, two-week crossover study will be conducted to assess the study objectives. The study will enroll 24 participants with insulin pump-treated type 1 diabetes. Upon stud...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- T1D ≥ 2 years
- Use of insulin pump therapy (without sensor-augmented insulin suspension/adjustment functionality) ≥ 6 months
- Use of CGM (real-time or intermittently scanned) ≥ 3 months and ≥ 70% during the previous 14 days
- HbA1c ≤ 70 mmol/l (8.5%)
- Performs aerobic exercise on a regular basis (≥ 2 times per week; self-reported) and desires to exercise per American Diabetes Association guidelines (150 minutes per week) during the study.
- Use of carbohydrate counting and bolus calculator (self-reported)
- Sensor glucose level \< 3.9 mmol/l on ≥ 4/14 previous days assessed by CGM data
Exclusion
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
- Known or suspected allergies to glucagon or related products
- History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients
- Patients with pheochromocytoma or insulinoma
- Hypoglycemia unawareness
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Inability to understand the individual information and to give informed consent
- Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
- Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04764968
Start Date
April 27 2021
End Date
January 28 2022
Last Update
September 7 2022
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, 2820