Specialised Dietary Fibre Intervention in Children with Type 1 Diabetes

Not Applicable

Recruiting

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

• Registration Number: ACTRN12621001527853
• Lead Sponsor: Queensland Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-10
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Children and adolescents aged 5 – 14 years (inclusive) with T1D that was diagnosed at least 3 months prior to entry into the study
- HbA1c less than or equal to 9% (75 mmol/mol) at the time of entry into the study
- BMI between 15th centile and 85th centile, inclusive
- The child/adolescent and their family are willing and able to follow the study protocol

Exclusion Criteria

- Concomitant disease or treatment that may, in the judgement of the investigators, impact on glycaemic control, insulin requirements or other outcome measures
- Hypoglycaemia unawareness
- History or symptoms of malabsorption or gastrointestinal disease, including coeliac disease
- Known liver or renal disease
- On a restricted or special diet that would impact their ability to take the supplement e.g. intermittent fasting or ketogenic diet
- Use of medication other than insulin that affects glucose homeostasis
- Antibiotic usage within the six weeks prior to entry into the study or anticipated usage during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified