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The Steno 780G Study

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ClinicalTrials.gov Identifier: NCT04914910
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Merete Bechmann Christensen, Steno Diabetes Center Copenhagen

Tracking Information
First Submitted Date  ICMJE May 31, 2021
First Posted Date  ICMJE June 7, 2021
Last Update Posted Date June 10, 2021
Estimated Study Start Date  ICMJE June 2021
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2021)
Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 [ Time Frame: 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)).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2021)
  • 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 ]
  • Difference in mean glucose [ Time Frame: From baseline to week 14 ]
    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 [ Time Frame: From baseline to week 14 ]
    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 [ Time Frame: From baseline to week 14 ]
    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). [ Time Frame: From baseline to week 14 ]
    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). [ Time Frame: From baseline to week 14 ]
    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). [ Time Frame: From baseline to week 14 ]
    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). [ Time Frame: From baseline to week 14 ]
    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). [ Time Frame: From baseline to week 14 ]
    From insulin pump data downloads
  • HbA1c [ Time Frame: From baseline to week 14 ]
  • Body weight [ Time Frame: From baseline to week 14 ]
  • Total daily insulin dose [ Time Frame: From baseline to week 14 ]
    Total daily insulin dose assessed by 2-week insulin pump data downloads
  • Total daily carbohydrate intake [ Time Frame: From baseline to week 14 ]
    Total daily carbohydrate intake assessed by 2-week insulin pump data downloads.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2021)
  • Number of daily carbohydrate entries in the insulin pump assessed by 2-week insulin pump data downloads [ Time Frame: From baseline to week 14 ]
    assessed by 2-week insulin pump data downloads
  • Hypoglycaemia awareness status. [ Time Frame: From baseline to week 14 ]
    Assesed by GOLD and Pedersen-Bjerggaard scale, low scores means aware, high scores means unawareness
  • Diabetes Treatment Satisfaction Questionnaire scores [ Time Frame: From baseline to week 14 ]
    Assessed by Diabetes Treatment Satisfaction Questionnaire. Scores from -36 to 36, high scores means higher satisfaction
  • Hypoglycaemia Fear Survey scores [ Time Frame: From baseline to week 14 ]
    Assessed by Hypoglycemia Fear Survey questionnaire. Scores from 0 to 52, higher scores indicate worse outcome
  • Diabetes Distress Scale scores [ Time Frame: From baseline to week 14 ]
    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.
  • Pittsburgh Sleep Quality Index scores [ Time Frame: From baseline to week 14 ]
    Assessed by PTQI questionnaire
  • Sleep efficiency (%) assessed by Actigraph GT3x [ Time Frame: From baseline to week 14 ]
    assessed by Actigraph GT3x
  • Physical activity level (sedentary, light, moderate-to-vigorous) assessed by Actigraph GT3x [ Time Frame: From baseline to week 14 ]
    assessed by Actigraph GT3x
  • Difference in number of severe hypoglycaemia events (cognitive impairment requiring external assistance for recovery). [ Time Frame: From baseline to week 14 ]
    Assessed by questionnaire
Original Other Pre-specified Outcome Measures
 (submitted: May 31, 2021)
  • Number of daily carbohydrate entries in the insulin pump assessed by 2-week insulin pump data downloads [ Time Frame: From baseline to week 14 ]
    assessed by 2-week insulin pump data downloads
  • Hypoglycaemia awareness status. [ Time Frame: From baseline to week 14 ]
    Assesed by GOLD and Pedersen-Bjerggaard scale
  • Diabetes Treatment Satisfaction Questionnaire scores [ Time Frame: From baseline to week 14 ]
    Assessed by DTSQ questionnaire
  • Hypoglycaemia Fear Survey scores [ Time Frame: From baseline to week 14 ]
    Assessed by HFS questionnaire
  • Diabetes Distress Scale scores [ Time Frame: From baseline to week 14 ]
    Assessed by DDS questionnaire
  • Pittsburgh Sleep Quality Index scores [ Time Frame: From baseline to week 14 ]
    Assessed by PTQI questionnaire
  • Sleep efficiency (%) assessed by Actigraph GT3x [ Time Frame: From baseline to week 14 ]
    assessed by Actigraph GT3x
  • Physical activity level (sedentary, light, moderate-to-vigorous) assessed by Actigraph GT3x [ Time Frame: From baseline to week 14 ]
    assessed by Actigraph GT3x
  • Difference in number of severe hypoglycaemia events (cognitive impairment requiring external assistance for recovery). [ Time Frame: From baseline to week 14 ]
    Assessed by questionnaire
 
Descriptive Information
Brief Title  ICMJE The Steno 780G Study
Official Title  ICMJE Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets: A Randomised Controlled Trial - The Steno 780G Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 780G-780G
    Participants will use MiniMed 780G system for 14 weeks + 14 weeks
    Intervention: Device: Minimed 780G insulin pump
  • 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.
    Intervention: Device: Minimed 780G insulin pump
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Merete B Christensen +4523811264 merete.bechmann.christensen@regionh.dk
Contact: Kirsten Noergaard +4527131011 kirsten.noergaard@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04914910
Other Study ID Numbers  ICMJE Steno 780G
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Merete Bechmann Christensen, Steno Diabetes Center Copenhagen
Study Sponsor  ICMJE Steno Diabetes Center Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Steno Diabetes Center Copenhagen
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP