The Steno 780G Study

Steno Diabetes Centers

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Minimed 780G insulin pump

Study type: Interventional

Funder types: Other

Identifiers

NCT04914910

Steno 780G

Details and patient eligibility

About

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 sensors still does not meet the recommended sensor-based glycaemic targets. Automated insulin delivery systems, also known as closed-loop systems, have shown to improve TIR, TAR, and TBR compared with insulin pump and CGM systems that cannot automatically dose insulin.

The primary objective of the Steno 780G study is to test the effects of the MiniMed 780G system in persons with T1D treated with insulin pump and CGM/isCGM who are not meeting glycaemic targets.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

780G-780G

Experimental group

Description:

Participants will use MiniMed 780G system for 14 weeks + 14 weeks

Treatment:

Device: Minimed 780G insulin pump

Usual Care - 780G

Placebo Comparator group

Description:

Participants will continue with their usual insulin pump for 14 weeks. After completion of the first 14-week periode, they switch to 780G for another 14 weeks.

Treatment:

Device: Minimed 780G insulin pump