ACTRN12624001025527Not yet recruitingUnknown
Redefining Glucose Thresholds for Hypoglycaemia Management in Children with Type 1 Diabetes on Closed Loop Therapy: A Cross-over Clinical Trial
Perth Children's Hospital0 sites40 target enrollmentStarted: August 23, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 6 Years to 18 Years (—)
- Sex
- All
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.
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