The Steno 780G Study

NCT ID: NCT04914910

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2023-03-29

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 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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

780G-780G

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

Group Type: EXPERIMENTAL

Minimed 780G insulin pump

Intervention Type: DEVICE

This will be a 14-week, open-label, randomised, parallel-group, controlled trial comparing the efficacy of an AHCL system (MiniMed 780G, Medtronic Diabetes, Northridge, CA) with usual care (i.e., a person's usual insulin pump and CGM/isCGM system). After the 14-week trial period, the control group switches to treatment with the MiniMed 780G system. The intervention group continues with the MiniMed 780G system. Both groups are monitored for another 14 weeks.

Usual Care - 780G

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.

Group Type: PLACEBO_COMPARATOR

Minimed 780G insulin pump

Intervention Type: DEVICE

This will be a 14-week, open-label, randomised, parallel-group, controlled trial comparing the efficacy of an AHCL system (MiniMed 780G, Medtronic Diabetes, Northridge, CA) with usual care (i.e., a person's usual insulin pump and CGM/isCGM system). After the 14-week trial period, the control group switches to treatment with the MiniMed 780G system. The intervention group continues with the MiniMed 780G system. Both groups are monitored for another 14 weeks.

Interventions

Minimed 780G insulin pump

This will be a 14-week, open-label, randomised, parallel-group, controlled trial comparing the efficacy of an AHCL system (MiniMed 780G, Medtronic Diabetes, Northridge, CA) with usual care (i.e., a person's usual insulin pump and CGM/isCGM system). After the 14-week trial period, the control group switches to treatment with the MiniMed 780G system. The intervention group continues with the MiniMed 780G system. Both groups are monitored for another 14 weeks.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Merete Bechmann Christensen

Principal Investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Steno Diabetes Center Copenhagen

Gentofte Municipality, , Denmark

Countries

Denmark

Other Identifiers

Steno 780G

Identifier Type: -

Identifier Source: org_study_id