Redefining Glucose thresholds for Hypo Treatment in Children with Type 1 Diabetes on Closed loop Therapy

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes; Metabolic and Endocrine - Diabetes; Public Health - Health service research

• Registration Number: ACTRN12624001025527
• Lead Sponsor: Perth Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-23
• Last Update Posted: 2024-09-02

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Diagnosis of Type 1 diabetes
2.6 to 18 years
3.Duration of diabetes of >12 months
4.On advanced closed loop therapy
4.1for at least 4 weeks and
4.2using the system optimally for >80% in last 2 weeks.

Exclusion Criteria

1.Impaired hypoglycaemia awareness. Self-reported Gold score greater than or equal to 4 (these patients need higher glucose targets). For young children (age 6 to 10 years or if the child is developmentally young to self-report), parent-reported response will be used.
2.Increased time spent in hypoglycaemia as documented on CGM (>2% of time spent <3.0 mmol/L and/or >6% of time spent <3.9 mmol/L) for last two weeks
3.Families not willing to try lower cut-off due to fear of hypoglycaemia.
4.Severe hypoglycaemia (coma, convulsion or altered consciousness requiring third party assistance) in last 12 months.
5.Any medical or psychological disease state of the child and/or caregiver that limits capacity to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time spent in hypoglycaemia <3.0 mmol/l[Continuous Glucose Monitoring (CGM) During the 10-week period (4 weeks intervention, 2 weeks washout, 4 weeks standard)]

Secondary Outcome Measures

Name	Time	Method
Time in range 3.9-10.0 mmol/l[Continuous Glucose Monitoring (CGM) During the 10-week period (4 weeks intervention, 2 weeks washout, 4 weeks standard)];Time spent in hyperglycaemia >10.0 mmol/l[Continuous Glucose Monitoring (CGM) During the 10-week period (4 weeks intervention, 2 weeks washout, 4 weeks standard)];Time spent in hyperglycaemia >13.9 mmol/l[Continuous Glucose Monitoring (CGM) During the 10-week period (4 weeks intervention, 2 weeks washout, 4 weeks standard)];Participant’s acceptability of revised hypoglycaemia cut-off[Open-ended questions in semi-structured interview (Telehealth), conducted by a clinical diabetes nurse educator who is qualified to undertake qualitative research. These interviews will take approximately 30 minutes, and will be audio-recorded for transcription. At the end of the 10 weeks of study participation]