Assessment of closed loop technology in young children with Type 1 Diabetes Aged 2-7

Not Applicable

Withdrawn

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

• Registration Number: ACTRN12622000472774
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-25
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Type 1 diabetes (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus, diagnosed at least 1 year ago)
2.CSII therapy for at least 3 months
3.Age 2 to 7 years (inclusive)
4.Total daily insulin of greater or equal 8 units/day in last 2 weeks
5.Participant and parent willing to follow study instructions
6.Living in an area with internet and cellular coverage

Exclusion Criteria

1. Commenced CGM in the 3 months prior to screening visit
2. Using advanced hybrid closed loop system: Control IQ
3. Uncontrolled coeliac disease
4. Uncontrolled thyroid disease
5. Inability or unwillingness to meet protocol requirements
6. Unwilling to perform 3 to 4 finger stick blood glucose measurements daily
7. Use of Hydroxyurea medication
8. Poor vision (of primary caregiver) precluding the use of investigational technology

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of time spent in target glucose range (3.9 - 10 mmol/L) measured at 5-minutely intervals by a blinded CGM over 2 weeks starting at 13-15 weeks post randomisation. <br><br>[Baseline and at the last visit (13-15 weeks post randomisation) ]