Specialised Fibre Supplement in Type 1 Diabetes

Not Applicable

Completed

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

• Registration Number: ACTRN12618001391268
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-20
• Study Completion: 2019-05-31
• Last Update Posted: 27 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

•18 to 45 years, males and females
•Clinical diagnosis of T1D for at least 6 months
•HbA1c less than or equal to 8.5%
•Willing and able to follow study protocol
•stable disease management

Exclusion Criteria

Current or planned pregnancy or lactation during the study
•Use of diabetes medications other than insulin that affect glucose homeostasis
•Hypoglycaemia unawareness
•Concomitant disease or treatment that may, in the judgment of the investigators, impact on glycaemic control, insulin requirements or other outcome measures
•History or symptoms of gastrointestinal disease or malabsorption, including coeliac disease
•Any known condition that could be associated with poor compliance (e.g. drug/alcohol abuse)
•Weight below 50kg and above 120kg (to ensure full dose between 0.33- 0.80g/kg/day)
•Known liver or renal disease
•Use of senor-augmented insulin therapy (i.e. Medtronic 640G pump with low glucose suspend)
•Unwillingness to maintain their normal stable diet during the study and/or following a restrictive diet that would impact their ability to take the supplement (e.g. intermittent fasting).
•Recent antibiotic usage (previous 6 weeks) or anticipated antibiotic usage during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified