Combining novel self-monitoring technologies for persuasive behaviour change in people at moderate or high risk of developing Type 2 diabetes

Not Applicable

Completed

• Conditions: Prediabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN17545949
• Lead Sponsor: oughborough University

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31661077 results (added 30/10/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33435946/ qualitative study results (added 14/01/2021) 2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28993396 (added 15/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-15
• Study Completion: 2017-12-31
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. At least 40 years of age
2. Own a compatible Android smartphone [Version 4.3+ with access to internet, Bluetooth and near infrared communication (NFC))]
3. Have a moderate or high risk of developing Type 2 diabetes (score =16 points on a validated Type 2 diabetes screening survey)

Exclusion Criteria

1. Have a clinical diagnosis of Type 1 or Type 2 diabetes or a HbA1c reading of >6.4%
2. Unable/unwilling to provide informed consent
3. Unable/unwilling to adhere to the study protocol
4. Unable to understand written/verbal English
5. Pregnant (suspected or confirmed)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device engagement will be assessed by:<br>1. Time spent on the official LibreLink application using Ethica Data at 1, 2, 3, 4, 5, and 6 weeks<br>2. Time spent on the official Fitbit application using Ethica Data at 1, 2, 3, 4, 5, and 6 weeks<br>3. The number of Freestyle Libre scans using LibreLinkUp application at 1, 2, 3, 4, 5, and 6 weeks<br>4. The number of user-driven Fitbit syncs using Fitabase at 1, 2, 3, 4, 5, and 6 weeks<br>5. Semi-structured interviews at 6 weeks

Secondary Outcome Measures

Name	Time	Method
1. Feasibility of delivering the intervention is measured using semi-structured interviews, researcher notes, Ethica Data, Fitabase, Diasend, LibreLinkUp at 1, 2, 3, 4, 5, and 6 weeks<br>2. Physical activity is measured using Fitbit Charge 2 at baseline and 1, 2, 3, 4, 5, and 6 weeks<br>3. Interstitial glucose levels are measured using Freestyle Libre at 1, 2, 3, 4, 5, and 6 weeks<br>4. Eligibility, uptake and retention is measured using researcher notes at baseline, 1, 2, 3, 4, 5, and 6 weeks<br>5. Changes in technology readiness is measured using the Technology Readiness Index 2.0 at baseline and 6 weeks<br>6. Health literacy is measured using the eHealth Literacy Scale at baseline and 6 weeks<br>7. Health status is measured using the 5Q-5D-5L at baseline and 6 weeks<br>8. Attitude about health is measured using the Risk Perception Survey – Developing Diabetes at baseline and 6 weeks