The Steno 780G Study

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914910
• Other study ID #: Steno 780G
• Status: Completed
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: March 29, 2023

Study information

• Verified date: September 2023
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 29, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Hypoglycaemia awareness status.	Assesed by GOLD and Pedersen-Bjerggaard scale, low scores means aware, high scores means unawareness	From baseline to week 14
Other	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
Other	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
Other	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
Other	Pittsburgh Sleep Quality Index scores	Assessed by PTQI questionnaire	From baseline to week 14
Other	Sleep efficiency (%) assessed by Actigraph GT3x	assessed by Actigraph GT3x	From baseline to week 14
Other	Physical activity level (sedentary, light, moderate-to-vigorous) assessed by Actigraph GT3x	assessed by Actigraph GT3x	From baseline to week 14
Other	Difference in number of severe hypoglycaemia events (cognitive impairment requiring external assistance for recovery).	Assessed by questionnaire	From baseline to week 14
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Glucose management indicator (an estimate of the laboratory HbA1c value).	From insulin pump data downloads	From baseline to week 14
Secondary	HbA1c		From baseline to week 14
Secondary	Body weight		From baseline to week 14
Secondary	Total daily insulin dose	Total daily insulin dose assessed by 2-week insulin pump data downloads	From baseline to week 14
Secondary	Total daily carbohydrate intake	Total daily carbohydrate intake assessed by 2-week insulin pump data downloads.	From baseline to week 14