Support through mobile messaging and digital health technology for diabetes

Not Applicable

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN15952379
• Lead Sponsor: niversity of Oxford

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35188478/ (added 22/02/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-18
• Last Update Posted: 26 September 2022
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1039

Inclusion Criteria

1. Willing and able to give informed consent for participation in the trial
2. Aged =35 years
3. Diagnosis of type 2 diabetes
4. Taking oral glucose-lowering treatment, blood pressure-lowering treatment, or lipid-lowering treatment (diabetes treatments) either alone or in combination
5. Has access to a UK registered mobile phone and is able, if necessary, with help (e.g. relative, friend, neighbour), to send, understand and retrieve brief SMS text-messages in the English language
6. Registered with a general practice participating in the trial

Exclusion Criteria

1. Pregnant, has been pregnant in the last three months or planning pregnancy during the course of the trial
2. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
3. Insulin treatment without concomitant use of oral glucose lowering treatment
4. Admitted to hospital within the last three months for hyper- or hypoglycaemia (self-report)
5. Another person in the household already participates in this trial
6. Currently using a pharmacist managed monitored dosage system for supply of medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite cardiovascular outcome based on the UKPDS risk engine equations calculated using measures of glycated haemoglobin (HbA1c), systolic and diastolic blood pressure, high-density lipoproteins (HDL) cholesterol, and total cholesterol measured at baseline and 52 weeks

Secondary Outcome Measures

Name	Time	Method
1. Long term glycaemic control measured using HbA1c level in blood samples at baseline and 52 weeks2. Systolic blood pressure measured using a sphygmomanometer at baseline and 52 weeks3.Diastolic blood pressure measured using a sphygmomanometer at baseline and 52 weeks4. Total and HDL cholesterol measured using blood samples at baseline and 52 weeks5. Quality of life measured using the EQ-5D-5L questionnaire at baseline, 13, 26, and 52 weeks