BetaMe. An innovative management of diabetes and prediabetes with a comprehensive digital health programme: a randomised controlled trial.

Not Applicable

Completed

• Conditions: diabetes; prediabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12617000549325
• Lead Sponsor: niversity of Otago, Wellington

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-19
• Study Completion: 2019-04-23
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 429

Inclusion Criteria

The study will be based in two regions of New Zealand, Midlands and Greater Wellington. Participating practices are those based in these regions that are interested in being involved in the study and able to commit to the study timeframes and process requirements. Practice recruitment will be through an opt-in process.

Patients will be eligible for inclusion if they meet the following inclusion criteria:
Have a current HbA1c of 41-70 mmol/mol (either from a test within three months prior to invitation to the study, or on the basis of an HbA1c test taken by the research team at invitation to the study).
Are not currently on insulin treatment for diabetes
Adults aged between 18-75 years, enrolled in participating primary care practices.
Have daily internet access (on any of computer/tablet/smartphone)
Are able to provide informed consent.

Exclusion Criteria

Patients will not be eligible for the study if they:
Are pregnant
Have cognitive impairment likely to be sufficient to hinder their understanding of the study or the programme, as this may negatively affect their self-management behaviour.56
Are unable to read and write in English.
Unable to use phone or computer due to physical disability such as poor eyesight or manual dexterity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c. Measured using whole blood sample collected in EDTA tube (2mls minimum) using Variant Turbo Ion Exchange HPLC.[At 12 months after study recruitment compared with baseline];Change in weight. Measured in kilograms using calibrated digital scales.[At 12 months after study recruitment compared with baseline]