SuMMiT-D
Research type
Research Study
Full title
Supporting people with type 2 diabetes in effective use of their medicine through a system comprising mobile health technology integrated with clinical care compared with usual care: a randomised controlled trial
IRAS ID
280928
Contact name
Andrew Farmer
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN15952379
Duration of Study in the UK
2 years, 1 months, 30 days
Research summary
Research Summary:
SuMMiT-D: SUpport through Mobile Messaging and dIgital health Technology for Diabetes.
Type 2 diabetes is a lifelong condition that causes a person's blood sugar to become too high. In the UK, it affects more than 4 million people. It can cause serious long-term health problems. Medicines to lower blood glucose, blood pressure, and cholesterol, can stop complications developing, if taken as intended. However, people are often concerned about starting new medicines and face difficulties in taking them regularly.
SuMMiT-D has drawn on patients' experiences and suggestions, and previous research which has shown that text messages can be effective for some conditions. Based on these we have developed text messages that aim to encourage and support people with type 2 diabetes in taking their medication and managing their condition. The messages were put together by health psychologists and have been reviewed by patients.
The aim of this trial is to compare the effectiveness and cost effectiveness of brief text messaging to support patients with type 2 diabetes taking diabetes medicine (glucose, blood pressure or lipid lowering) in reducing risk factors for diabetes complications, with usual care.
958 patients with type 2 diabetes, ≥35 years of age, who are taking oral glucose lowering treatment, blood pressure lowering treatment or lipid lowering treatment (diabetes treatments) either alone or in combination, will be invited or approached by their healthcare team or may see trial promotional material. Interested people will contact the trial team to register their interest in taking part. Participants will be randomised to either tailored condition specific text messages or non-health related messages for 12 months following randomisation. They will be asked to complete questionnaires at baseline, 13-, 26-, and 52-weeks.
Notes reviews will be conducted at baseline, 12 months.
Up to 60 participants will also take part in qualitative interviews.Summary of results:
Support through mobile messaging and digital health technology for diabetes. ISRCTN15952379
Background and study aims
Type 2 diabetes is a lifelong condition that causes a person’s blood sugar (glucose) to become too high. It can cause serious long-term health problems. In the UK, it affects more than 5 million people. Medicines to lower blood glucose, blood pressure, and cholesterol, can stop the complications of diabetes developing, if taken as intended. However, people often face difficulties in taking medicines regularly and have concerns about starting new medicines.
The SuMMiT-D team have developed a new text messaging system that provides hints and tips about managing diabetes. The system was compared to usual diabetes care, by asking some people to use the system alongside their usual care.
The aim of this study was to help people with type 2 diabetes reduce their 10-year risk of heart disease. This is done by comparing how effective sending health-related text messages to support people with type 2 diabetes was, compared with usual care. There were other measures of health, quality of life and use of medication including a medication adherence scale used.
Participants were eligible if they were registered with a participating GP practice, aged 35 years or over, diagnosed with type 2 diabetes, with access to a mobile phone, and prescribed tablets to lower their blood glucose, blood pressure or cholesterol levels. Potential participants were unable to participate if they were pregnant (or have been pregnant within the last three months), or another person in the household was already taking part in this study.
Participants were assigned, by chance to one of two groups, the control group continuing with usual care, the intervention group receiving 3 to 4 health-related text messages from the SuMMiT-D system each week in addition to continuing with their usual care.
Participants in both groups were asked to complete questionnaires at the start of the study, and again after 13, 26, and 52 weeks. Participation in the study was for 52 weeks. Reviews were conducted by the study team at the start of the study and at 52 weeks.
A proportion of the participants were invited to be interviewed either at the start or end of their participation (or both), to discuss their views about self-management of their diabetes and the system.
A group of patients and members of the public contributed to study design, help prepare study materials and advised on interpretation of the findings and how best to share findings with communities.
Between March and July 2021, 1039 participants were randomised (521 intervention, 518 usual care); 962 were analysed for their risk of heart disease, with 50 (4.8%) lost to follow-up at 12 months. Mean (SD) age was 66.3 (9.7) years, 35.7% were female, mean diabetes duration was 10.6 (7.7 years) and mean Medication Adherence Report Scale (MARS) was 23.4 (2.6). At 12 months, there was no difference in change in coronary heart disease risk (mean 37.4% vs 37.5%); secondary clinical outcomes and health status were also similar, and the incremental cost-effectiveness ratio exceeded thresholds set by the National Institute for Health and Care Excellence (NICE). Self-reported medication adherence was higher with the intervention (mean adjusted difference 0.36, 95% CI 0.054 to 0.664; p=0.021). Two unrelated serious adverse events occurred in the intervention group. No subgroups of participants showed an effect from the intervention on heart disease risk. accompanying process evaluation showed that people experienced the messages in different ways depending on their circumstances, prior routines, and how they felt about living with diabetes. There was no single ‘type’ of participant who found the messages useful; instead, their perceived value often changed over time.
This SMS text messaging-based intervention did not have an effect on overall heart disease risk when tested among people with type 2 diabetes in the UK receiving routine care. Despite apparent engagement by participants, it is possible that the relatively high levels of medication adherence among participants may have limited opportunities to observe an impact of the intervention.
The study was run from:1. University of Oxford (Nuffield Department of Primary Care Health Sciences and the Institute of Biomedical Engineering) (UK) 2. University of Manchester (UK) 3. Bangor University (UK)
REC name
West of Scotland REC 5
REC reference
20/WS/0103
Date of REC Opinion
25 Aug 2020
REC opinion
Favourable Opinion