Clinical trial NCT04914910: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14
timeFrame: From baseline to week 14
Secondary outcomes:
measure: 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))
timeFrame: From baseline to week 14
measure: Difference in mean glucose
timeFrame: From baseline to week 14
measure: Difference in standard deviation
timeFrame: From baseline to week 14
measure: Difference in coefficient of variation
timeFrame: From baseline to week 14
measure: Percentage of time with glucose values < 3.9 mmol/l (TBR level 1).
timeFrame: From baseline to week 14
measure: Percentage of time with glucose values < 3.0 mmol/l (TBR level 2).
timeFrame: From baseline to week 14
measure: Percentage of time with glucose values > 10.0 mmol/l (TAR level 1).
timeFrame: From baseline to week 14
measure: Percentage of time with glucose values > 13.9 mmol/l (TAR level 2).
timeFrame: From baseline to week 14
measure: Glucose management indicator (an estimate of the laboratory HbA1c value).
timeFrame: From baseline to week 14
measure: HbA1c
timeFrame: From baseline to week 14
measure: Body weight
timeFrame: From baseline to week 14
measure: Total daily insulin dose
timeFrame: From baseline to week 14
measure: Total daily carbohydrate intake
timeFrame: From baseline to week 14
Other outcomes:
measure: Number of daily carbohydrate entries in the insulin pump assessed by 2-week insulin pump data downloads
timeFrame: From baseline to week 14
measure: Hypoglycaemia awareness status.
timeFrame: From baseline to week 14
measure: Diabetes Treatment Satisfaction Questionnaire scores
timeFrame: From baseline to week 14
measure: Hypoglycaemia Fear Survey scores
timeFrame: From baseline to week 14
measure: Diabetes Distress Scale scores
timeFrame: From baseline to week 14
measure: Pittsburgh Sleep Quality Index scores
timeFrame: From baseline to week 14
measure: Sleep efficiency (%) assessed by Actigraph GT3x
timeFrame: From baseline to week 14
measure: Physical activity level (sedentary, light, moderate-to-vigorous) assessed by Actigraph GT3x
timeFrame: From baseline to week 14
measure: Difference in number of severe hypoglycaemia events (cognitive impairment requiring external assistance for recovery).
timeFrame: From baseline to week 14
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
References: