Status:
COMPLETED
The Steno 780G Study
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Treatment with insulin pumps and sensor-based glucose monitoring has proven superior to other treatment methods in type 1 diabetes. Still, the majority of people treated with insulin pumps and glucose...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Type 1 diabetes ≥2 years.
- HbA1c \>=58 mmol/mol
- Insulin pump treatment ≥12 months
- CGM or isCGM use ≥6 months
- Novorapid use ≥1 week
- Carbohydrate counting and use of the insulin pump bolus calculator for most snacks and meals.
- Carbohydrate intake \>80 grams per day (assessed by review of intake recorded in the insulin pump during the 2 weeks prior to the screening visit)
Exclusion
- Breast-feeding, pregnancy or planning to become pregnant.
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start.
- Use of hybrid closed-loop systems
- Daily use of paracetamol (acetaminophen)
- Alcohol or drug abuse.
- Severe cardiac disease or retinopathy contraindicating HbA1c \<53 mmol/mol.
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the person unsuitable for study participation.
- Lack of compliance with key study procedures at the discretion of the investigator.
- Unacceptable adverse events at the discretion of the investigator.
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04914910
Start Date
June 8 2021
End Date
March 29 2023
Last Update
September 21 2023
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, 2820