Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial
Primary result · TIR (3.9-10.0 mmol/l) by CGMResult — go to the resultMean difference 2.4 %-points 95% CI −0.7 to 5.5Authors' conclusion
Use of low-dose dasiglucagon to prevent and treat non-severe hypoglycaemia during free-living conditions was safe, fast and efficacious while significantly reducing the total daily carbohydrate intake and yielding high treatment satisfaction.
Study context
- Population
- Adults with insulin pump-treated T1D (HbA1c ≤70 mmol/mol [8.5%]), free-living conditionscompleted
- Participants
- 24 adults
- Comparison
- Pen-administered low-dose dasiglucagon (dasiglucagon intervention (DASI)) vs usual care for non-severe hypoglycaemia
Methodological detailsPhase II, open-label, two-period crossover, 2 week periods
- Phase II
- Open-label
- Two-period crossover
- 2 week periods
Primary result
TIR (3.9-10.0 mmol/l) by CGM
Mean difference
2.4 %-points
95% CI −0.7 to 5.5
DASIvs Usual care
mean difference 2.4 %-points (95% CI −0.7 to 5.5)
As reported in the abstract
Further findings
| Outcome | Mean difference (%-points) (95% CI) | |
|---|---|---|
| TBR (<3.9 mmol/l) | −0.5 (−1.2 to 0.2) | |
| −1.5−1−0.500.5Difference, %-points (linear scale) |
Recovery rate (time from hypoglycaemia treatment to euglycaemia)
- Faster recovery in DASI period
- 44% (11, 87)
Total daily carbohydrate intake
- Reduction in DASI period
- 11% (−18, −3)
Likely to include dasiglucagon in future routine hypoglycaemia management
- Participants likely to include dasiglucagon
- 96% (p<0.0001)
Safety
Safety and tolerability
- Dasiglucagon use was safe and well tolerated; mild nausea most frequent adverse effect
Original publication
Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial. Diabetologia. Published 11 April 2023. doi:10.
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