ifestyle monitoring and coaching using the mobile DIAMETER application in primary and secondary care (DIAMETER-1 study): protocol for a study on intervention usage and acceptability

Recruiting

• Conditions: Diabetes; Diabetes Mellitus type 2; 10018424

• Registration Number: NL-OMON56033
• Lead Sponsor: niversiteit Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

• Being diagnosed with type 2 diabetes;
• Being treated in the outpatient clinic at ZGT or in primary care;
• Being familiar with using a smartphone.

Exclusion Criteria

• Dependence on renal replacement therapy;
• Severe general diseases or mental disorders making participation in the study
impossible;
• Insufficient mastery of the Dutch language;
• Other CGM device than Freestyle Libre.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters concern insight into the usability (phase 1),<br /><br>intervention usage (phase 2) and acceptability (phase 2) of the Diameter.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In phase 2, secondary objectives are to explore behavioural (e.g. physical<br /><br>activity), physiological (e.g. BMI), psychological (e.g. health-related quality<br /><br>of life) and clinical outcomes (e.g. glucose control, estimated HbA1c values).</p><br>