Back to resultsThe Steno 780G Study
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Minimed 780G insulin pump
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
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 ≥4 weeks
- 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.
Sites / Locations
- Steno Diabetes Center Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
780G-780G
Usual Care - 780G
Arm Description
Participants will use MiniMed 780G system for 14 weeks + 14 weeks
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.
Outcomes
Primary Outcome Measures
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)).
Secondary Outcome Measures
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))
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)):
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)):
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)):
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)):
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)):
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
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))
Glucose management indicator (an estimate of the laboratory HbA1c value).
From insulin pump data downloads
HbA1c
Body weight
Total daily insulin dose
Total daily insulin dose assessed by 2-week insulin pump data downloads
Total daily carbohydrate intake
Total daily carbohydrate intake assessed by 2-week insulin pump data downloads.
Full Information
NCT ID
NCT04914910
First Posted
May 31, 2021
Last Updated
September 19, 2023
Sponsor
Steno Diabetes Center Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT04914910
Brief Title
The Steno 780G Study
Official Title
Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets: A Randomised Controlled Trial - The Steno 780G Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
March 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steno Diabetes Center Copenhagen
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
780G-780G
Arm Type
Experimental
Arm Description
Participants will use MiniMed 780G system for 14 weeks + 14 weeks
Arm Title
Usual Care - 780G
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Minimed 780G insulin pump
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14
Description
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)).
Time Frame
From baseline to week 14
Secondary Outcome Measure Information:
Title
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))
Time Frame
From baseline to week 14
Title
Difference in mean glucose
Description
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)):
Time Frame
From baseline to week 14
Title
Difference in standard deviation
Description
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)):
Time Frame
From baseline to week 14
Title
Difference in coefficient of variation
Description
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)):
Time Frame
From baseline to week 14
Title
Percentage of time with glucose values < 3.9 mmol/l (TBR level 1).
Description
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)):
Time Frame
From baseline to week 14
Title
Percentage of time with glucose values < 3.0 mmol/l (TBR level 2).
Description
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)):
Time Frame
From baseline to week 14
Title
Percentage of time with glucose values > 10.0 mmol/l (TAR level 1).
Description
difference in change in the given variable between treatment groups from baseline to
Time Frame
From baseline to week 14
Title
Percentage of time with glucose values > 13.9 mmol/l (TAR level 2).
Description
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))
Time Frame
From baseline to week 14
Title
Glucose management indicator (an estimate of the laboratory HbA1c value).
Description
From insulin pump data downloads
Time Frame
From baseline to week 14
Title
HbA1c
Time Frame
From baseline to week 14
Title
Body weight
Time Frame
From baseline to week 14
Title
Total daily insulin dose
Description
Total daily insulin dose assessed by 2-week insulin pump data downloads
Time Frame
From baseline to week 14
Title
Total daily carbohydrate intake
Description
Total daily carbohydrate intake assessed by 2-week insulin pump data downloads.
Time Frame
From baseline to week 14
Other Pre-specified Outcome Measures:
Title
Number of daily carbohydrate entries in the insulin pump assessed by 2-week insulin pump data downloads
Description
assessed by 2-week insulin pump data downloads
Time Frame
From baseline to week 14
Title
Hypoglycaemia awareness status.
Description
Assesed by GOLD and Pedersen-Bjerggaard scale, low scores means aware, high scores means unawareness
Time Frame
From baseline to week 14
Title
Diabetes Treatment Satisfaction Questionnaire scores
Description
Assessed by Diabetes Treatment Satisfaction Questionnaire. Scores from -36 to 36, high scores means higher satisfaction
Time Frame
From baseline to week 14
Title
Hypoglycaemia Fear Survey scores
Description
Assessed by Hypoglycemia Fear Survey questionnaire. Scores from 0 to 52, higher scores indicate worse outcome
Time Frame
From baseline to week 14
Title
Diabetes Distress Scale scores
Description
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.
Time Frame
From baseline to week 14
Title
Pittsburgh Sleep Quality Index scores
Description
Assessed by PTQI questionnaire
Time Frame
From baseline to week 14
Title
Sleep efficiency (%) assessed by Actigraph GT3x
Description
assessed by Actigraph GT3x
Time Frame
From baseline to week 14
Title
Physical activity level (sedentary, light, moderate-to-vigorous) assessed by Actigraph GT3x
Description
assessed by Actigraph GT3x
Time Frame
From baseline to week 14
Title
Difference in number of severe hypoglycaemia events (cognitive impairment requiring external assistance for recovery).
Description
Assessed by questionnaire
Time Frame
From baseline to week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Steno Diabetes Center Copenhagen
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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The Steno 780G Study
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