The Steno 780G Study

Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets: A Randomised Controlled Trial - The Steno 780G Study

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Minimed 780G insulin pump

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Gentofte, Denmark, 2820
    • Steno Diabetes Center Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 780G-780G; Participants will use MiniMed 780G system for 14 weeks + 14 weeks	Device: 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.
Placebo Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep)):	From baseline to week 14
Difference in standard deviation	difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep)):	From baseline to week 14
Difference in coefficient of variation	difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep)):	From baseline to week 14
Percentage of time with glucose values < 3.9 mmol/l (TBR level 1).	difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep)):	From baseline to week 14
Percentage of time with glucose values < 3.0 mmol/l (TBR level 2).	difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep)):	From baseline to week 14
Percentage of time with glucose values > 10.0 mmol/l (TAR level 1).	difference in change in the given variable between treatment groups from baseline to	From baseline to week 14
Percentage of time with glucose values > 13.9 mmol/l (TAR level 2).	difference in change in the given variable between treatment groups from baseline to Week 14 assessed by 2 weeks of CGM data (each of the endpoints will be calculated for the following 3-time intervals: 6 AM - 12 AM (wake), and 12 AM - 6 AM (sleep), 12 AM - 12AM (wake + sleep))	From baseline to week 14
Glucose management indicator (an estimate of the laboratory HbA1c value).	From insulin pump data downloads	From baseline to week 14
HbA1c		From baseline to week 14
Body weight		From baseline to week 14
Total daily insulin dose	Total daily insulin dose assessed by 2-week insulin pump data downloads	From baseline to week 14
Total daily carbohydrate intake	Total daily carbohydrate intake assessed by 2-week insulin pump data downloads.	From baseline to week 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of daily carbohydrate entries in the insulin pump assessed by 2-week insulin pump data downloads	assessed by 2-week insulin pump data downloads	From baseline to week 14
Hypoglycaemia awareness status.	Assesed by GOLD and Pedersen-Bjerggaard scale, low scores means aware, high scores means unawareness	From baseline to week 14
Diabetes Treatment Satisfaction Questionnaire scores	Assessed by Diabetes Treatment Satisfaction Questionnaire. Scores from -36 to 36, high scores means higher satisfaction	From baseline to week 14
Hypoglycaemia Fear Survey scores	Assessed by Hypoglycemia Fear Survey questionnaire. Scores from 0 to 52, higher scores indicate worse outcome	From baseline to week 14
Diabetes Distress Scale scores	Assessed by Diabetes Distress Scale questionnaire. DDS consists of 17 items on a 6-point scale. A score of ≥3 indicates a high diabetes distress and a score lower than 3 and ≥2 indicates a moderate diabetes distress.	From baseline to week 14
Pittsburgh Sleep Quality Index scores	Assessed by PTQI questionnaire	From baseline to week 14
Sleep efficiency (%) assessed by Actigraph GT3x	assessed by Actigraph GT3x	From baseline to week 14
Physical activity level (sedentary, light, moderate-to-vigorous) assessed by Actigraph GT3x	assessed by Actigraph GT3x	From baseline to week 14
Difference in number of severe hypoglycaemia events (cognitive impairment requiring external assistance for recovery).	Assessed by questionnaire	From baseline to week 14

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: Steno 780G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No