Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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 treating mild hypoglycemia in insulin pump-treated people with type 1 diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center Copenhagen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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