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Completed

NCT Number: NCT04914910

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 7, 2021
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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