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.
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 study enrollment, participants will complete two consecutive 2-week periods - a 'usual care' period and 'dasiglucagon' period. During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension. During the 'dasiglucagon' period, participants will use pen-administered low-dose dasiglucagon to treat or prevent episodes of hypoglycemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Abdominal s.c. administration using a multi-dose reusable pen injector
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark
Difference in percentage of time in range between the two study periods
Sensor glucose level ≥ 3.9 mmol/l and ≤ 10.0 mmol/l
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in percentage of time in hypoglycemia between the two study periods
Sensor glucose level \< 3.9 mmol/l
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in percentage of time in hyperglycemia between the two study periods
Sensor glucose level \> 10 mmol/l
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in coefficient of variation (%) between the two study periods
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference between successful cases (%) of hypoglycemia treatment between the two study periods
Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level \> 3.9 mmol/l 30 minutes post-treatment
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in successful cases (%) of hypoglycemia treatment without subsequent hyperglycemia [sensor glucose level > 10 mmol/l during the first two hours post-treatment] between the two study periods
Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level \> 3.9 mmol/l 30 minutes post-treatment AND sensor glucose level ≤ 10 mmol/l during the first two hours post-treatment
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Difference in successful cases (%) of hypoglycemia prevention between the two study periods
Initial sensor glucose level \> 3.9 mmol/l AND sensor glucose level \< 3.9 for ≤ 15 consecutive minutes during the first two hours post-treatment
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in time from hypoglycemia treatment to euglycemia between the two study periods
Minutes from initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l to sensor glucose level ≥ 3.9 mmol/l
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration
Time frame: 2-week 'dasiglucagon' period
Difference between the average daily carbohydrate intake between the two study periods
Registered on the insulin pump
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference between the average total daily insulin dose between the two study periods
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in the number and intensity of episodes with nausea, headache, stomach-ache, palpitations and injection site pain between the two study periods
Intensity: mild/moderate/severe
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire
Scoring likely OR very likely on a four-point Likert scale
Time frame: At the end-of-study visit (estimated week 6)
Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies
Time frame: Measured 4 weeks after the 'dasiglucagon' period