The Steno 780G Study

NCT04914910 | Completed

• 1 other identifier: Steno 780G
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14

  Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 assessed by 2 weeks of CGM data (12 AM-12 AM (wake + sleep)).

  From baseline to week 14

Secondary Outcomes (13)

• Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 assessed by 2-week CGM data (6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep))

  From baseline to week 14

• Difference in mean glucose

  From baseline to week 14

• Difference in standard deviation

  From baseline to week 14

• Difference in coefficient of variation

  From baseline to week 14

• Percentage of time with glucose values < 3.9 mmol/l (TBR level 1).

  From baseline to week 14

Other Outcomes (9)

• Number of daily carbohydrate entries in the insulin pump assessed by 2-week insulin pump data downloads

  From baseline to week 14

• Hypoglycaemia awareness status.

  From baseline to week 14

• Diabetes Treatment Satisfaction Questionnaire scores

  From baseline to week 14

Study Arms (2)

780G-780G

EXPERIMENTAL

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

Device: Minimed 780G insulin pump

Usual Care - 780G

PLACEBO COMPARATOR

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.

Device: Minimed 780G insulin pump

Interventions

Minimed 780G insulin pump 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.

780G-780G; Usual Care - 780G

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 7, 2021
• Study Start: June 8, 2021
• Primary Completion: December 15, 2022
• Study Completion: March 29, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)