Testing a new blood glucose management software tool for people with type 2 diabetes mellitus

Not Applicable

• Conditions: Type 2 Diabetes Mellitus; Obesity; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12624000275561
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-18
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Aged >=18 years
•Type 2 diabetes with an HbA1c 65-90 mmol/mol on any hypoglycaemic therapeutic regimen other than insulin.
oIf the individual has a high baseline time-in-range, the potential improvements will be difficult to detect at smaller sample sizes, which necessitates selecting for those who have the greatest potential for benefit. Participants with an HbA1c >90 mmol/mol should have additional therapy initiated and will therefore be ineligible for this trial.
•Speaks and reads English
oDue to scope limitations, the application has only been developed in English
•Owns an iOS device capable of running iOS 16 and above
oThese are the technical specifications required to use the application
•Able to consume dairy milk and gluten

Exclusion Criteria

•Type 1 diabetes or forms of diabetes other than type 2.
•Changes to diabetes-related medications or dosing in the last three months
•Insulin or intention to initiate insulin therapy during the trial
oAlthough this application may have future benefit to people living with diabetes who require insulin therapy, the use of insulin will make it difficult to assess the isolated effect of dietary change on glycaemic management.
•Intention to change dosage of anti-hyperglycaemic agents or initiate continuous glucose monitoring during the trial
•Pregnancy
•Participation in another trial requiring a prescriptive nutritional intake.
oAs this study is examining the effect of changing nutritional intake informed by the application, the participant must be able to change their intake at will, which would contradict the trial requiring prescriptive nutritional intake.

Study & Design

• Study Type: Interventional
• Study Design: Not specified