Assessing efficacy and safety of Automated Insulin Delivery utilizing open source technology in children and adults with Type 1 Diabetes
- Conditions
- Type 1 DiabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12620000034932
- Lead Sponsor
- niversity of Otago
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1. Type 1 diabetes as per the American Diabetes Association classification for > 1 years prior to the Baseline Visit
2. Aged 7 - 70 years inclusive stratified into two groups (7 - 15 years inclusive and 16 - 70 years years inclusive) at Baseline
3. Currently on insulin pump therapy for > 6 months prior to the Baseline Visit
4. Mean HbA1c < 10.5% (91 mmol/mol) within 6 months prior to the Baseline Visit (minimum of one test)
5. Willing and able to adhere to the study protocol
6. Have daily access to a Wi-Fi network
1. If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary
2. Alcohol or drug dependence
3. Severe visual impairment that would impair use of the device
4. Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study
5. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study
6. Allergic or intolerant to NovoRapid® insulin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome, mean percentage of time spent in target glucose range (3.9 to 10.0 mmol/L) will be collected from days 155 – 168 (last 2 weeks of the RCT phase), and will be calculated for each participant by dividing the number of CGM measures within range by the total number of CGM measures recorded.<br>[The randomised clinical trial phase is 6-months duration, with the primary outcome measured at the end of this phase (day 155-168)]
- Secondary Outcome Measures
Name Time Method