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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

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Minimed 780G insulin pump Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.




Primary Outcome Measures :
  1. 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)).


Secondary Outcome Measures :
  1. 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 ]
  2. 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)):

  3. 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)):

  4. 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)):

  5. 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)):

  6. 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)):

  7. 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

  8. 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))

  9. Glucose management indicator (an estimate of the laboratory HbA1c value). [ Time Frame: From baseline to week 14 ]
    From insulin pump data downloads

  10. HbA1c [ Time Frame: From baseline to week 14 ]
  11. Body weight [ Time Frame: From baseline to week 14 ]
  12. Total daily insulin dose [ Time Frame: From baseline to week 14 ]
    Total daily insulin dose assessed by 2-week insulin pump data downloads

  13. Total daily carbohydrate intake [ Time Frame: From baseline to week 14 ]
    Total daily carbohydrate intake assessed by 2-week insulin pump data downloads.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. Pittsburgh Sleep Quality Index scores [ Time Frame: From baseline to week 14 ]
    Assessed by PTQI questionnaire

  7. Sleep efficiency (%) assessed by Actigraph GT3x [ Time Frame: From baseline to week 14 ]
    assessed by Actigraph GT3x

  8. Physical activity level (sedentary, light, moderate-to-vigorous) assessed by Actigraph GT3x [ Time Frame: From baseline to week 14 ]
    assessed by Actigraph GT3x

  9. Difference in number of severe hypoglycaemia events (cognitive impairment requiring external assistance for recovery). [ Time Frame: From baseline to week 14 ]
    Assessed by questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04914910


Contacts
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Contact: Merete B Christensen +4523811264 merete.bechmann.christensen@regionh.dk
Contact: Kirsten Noergaard +4527131011 kirsten.noergaard@regionh.dk

Locations
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Denmark
Steno Diabetes Center Copenhagen Recruiting
Gentofte, Denmark, 2820
Contact: Merete B Christensen    +4523811264    merete.bechmann.christensen@regionh.dk   
Contact: Kirsten Noergaard    +4527131011    kirsten.noergaard@regionh.dk   
Principal Investigator: Merete B. Christensen, MD         
Sub-Investigator: Karen Rytter, RD         
Sub-Investigator: Ajenthen Ranjan, MD         
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
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Responsible Party: Merete Bechmann Christensen, Principal Investigator, MD, PhD, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT04914910    
Other Study ID Numbers: Steno 780G
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs