The Steno 780G Study

Launched by STENO DIABETES CENTER COPENHAGEN · May 31, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.