The Co-Pilot trial: Closed loop in children and youth with type 1 diabetes and high-risk glycaemic control

Not Applicable

Active, not recruiting

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

• Registration Number: ACTRN12622001454763
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-14
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. Male or female aged 7 – 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. Minimum daily insulin requirement of greater than or equal to 8 units of insulin/day.
5. Willing and able to adhere to the study protocol.
6. Access to the internet and a computer system that meets requirements for uploading the study pump.

Exclusion Criteria

1.Previous use of closed loop technology prior to Baseline visit.
2.Previous significant adverse event at investigator discretion that precludes the participant safely using advanced diabetes technology/sensors e.g., unable to wear glucose sensors due to prior cutaneous adverse events.
3.Use of a medication indicative of moderate/severe diabetes complications (ACE inhibitors and statins are permitted).
4.Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
5.Current use of Metformin, SGLT-2 or GLP-1 medications.
6.History or current evidence of severe psychiatric disorder, uncontrolled seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), that in the opinion of the Investigator would limit study involvement or be a safety issue.
7.For diabetic retinopathy (DR) or other visual impairment, the following criteria apply:
A. or Minimal retinopathy (less than or equal to R1/M1) – no restriction on study entry. To follow established ISPAD screening guidelines as below.
B. If Grade 1 / Mild retinopathy (R2/M2) and HbA1c less than 10% (86mmol/mol) – no restriction to study entry.
C. If Grade 1 / Mild retinopathy (R2/M2) and HbA1c equal to or greater than 10% (86mmol/mol) – DR screening to be performed during the study pre-screening phase (not greater than 4 weeks prior to initiation of blinded CGM). If subject remains at Grade 1 / Mild retinopathy (R2/M2) and frequency of screening is equal to or more than 1 year (indicating less clinical concern), subject meets inclusion. If subject has progressed to Moderate (Grade 2) or Severe (Grade 3) DR, to be excluded as per below exclusion criteria.
D. Absolute exclusion: Any DR classed as Moderate (Grade 2) or Severe (Grade 3) non-proliferative retinopathy (known as equal to or more than R3/M3) is exclusive.
NB: ISPAD guidelines (2022) for who needs retinopathy screening to be followed while in study care. These are: Screening from age 11 years with 2-5years diabetes duration. Subsequent monitoring frequency 2-3 yearly (or as locally recommended/available).
E. History of severe visual impairment (which in the opinion of the Investigator would limit their successful involvement), is exclusive.
8.If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary.
9.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 glycated hemoglobin (HbA1C) from blood samples.[ At baseline, at 3 months post-RCT commencement (primary endpoint), and at 3, 6, and 9 months post-extension phase commencement. ]