Advanced hybrid closed loop/artificial pancreas for youth with type 1 diabetes using conventional injection therapy and high-risk glycaemic control

Not Applicable

Completed

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

• Registration Number: ACTRN12621000556842
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-12
• Study Completion: 2023-12-31
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male or female aged 13 – 25 years inclusive.
2. Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1.
3. Current HbA1c level of greater than or equal to 8.5% (69mmol/mol).
4. Not on insulin pump therapy prior to trial.
5. Minimum daily insulin requirement of greater than or equal to 0.5 units of insulin/kg/day.
6. Willing and able to adhere to the study protocol.
7. Access to the internet and a computer system that meets requirements for uploading the study pump.

Exclusion Criteria

1. Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted).
2. Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
3. Current use of SGLT-2 or GLP-1 medications.
4. Use of Hydroxyurea.
5. History or current evidence of significant seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator.
6. History of severe visual impairment, in the opinion of the Investigator.
7. If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary.
8. Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic control as measured by percentage of time in range (3.9 – 10mmol/L), by way of CGM data analysis.[ Baseline, 16 weeks post baseline.]