Randomised controlled trial investigating the safety and efficacy of an open source automated insulin delivery system without manual mealtime boluses, in people with type 1 diabetes

Not Applicable

Recruiting

• Conditions: Type 1 diabetes mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12622001400752
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-01
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Type 1 diabetes as per the American Diabetes Association classification for > 12 months prior to the screening visit
2. Aged 18 – 70 years inclusive
3. Willing and able to adhere to the study protocol

Exclusion Criteria

1. If female, is pregnant or plans to become pregnant while participating in the study. A positive pregnancy test at screening is exclusionary.
2. Use of non-insulin glucose lowering therapy within 3 months of study commencement.
3. Severe renal impairment (eGFR < 30 mL/min/1.73m2).
4. Any documented active or suspected malignancy, except appropriately treated basal cell or squamous cell carcinoma of the skin or any in situ” carcinoma.
5. Acute cardiovascular event (myocardial infarction, unstable angina, stroke) in the 3 months prior to study commencement.
6. Severe hypoglycaemia or diabetic ketoacidosis in the 3 months prior to study commencement.
7. Consumption of a very low carbohydrate diet, defined as carbohydrate intake <40g per day.
8. Inability to use insulin pump and mobile phone.
9. Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study.
10. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study.
11. Allergy to insulin NovoRapid®

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in range, defined as the percentage of the time that glucose (measured by the Dexcom G6 continuous glucose monitor) is between 3.9 and 10.0 mmol/L.[ Days 155-168, representing the final 14 days of the trial phase]