The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trial
1 Centre for Population Health Science, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK
2 Edinburgh Napier University, School of Nursing, Midwifery and Social Care, Sighthill Campus, Sighthill Court, Edinburgh EH11 4BN, UK
3 Metabolic Unit, Western General Hospital, NHS Lothian, Crewe Road S, Edinburgh EH4 TXU, UK
4 College of Medicine & Veterinary Medicine, The University of Edinburgh, The Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ, UK
5 Scottish Government, St Andrews House London Road, Edinburgh EH13DG, UK
Trials 2013, 14:198 doi:10.1186/1745-6215-14-198Published: 6 July 2013
Diabetes prevalence is increasing and current methods of management are unsustainable. Effective approaches to supporting self-management are required. The aim of this randomized controlled trial is to establish whether supported telemetric monitoring of glycemic control and blood pressure results in reductions in glycosylated hemoglobin (HbA1c; the primary outcome of a measure of long-term glycemic control) and secondary outcomes of blood pressure and weight among people with poorly controlled diabetes compared to a control group receiving usual care.
Design: multi-center, randomized controlled trial with embedded qualitative study.
Setting: primary care in Lothian, Kent, Glasgow and Borders regions in the UK.
Participants: people with type 2 diabetes and confirmed HbA1c >7.5% (58 mmol/mol).
Intervention/comparison: randomization to intervention or control groups will be performed by the Edinburgh Clinical Trials Unit. Participants in the intervention group will be shown how to use blood glucose and blood pressure monitors and weighing scales which use Bluetooth wireless technology to transmit readings via modem to a remote server. These participants will be asked to provide at least twice weekly measurements of morning and evening blood glucose and weekly measurements of weight and blood pressure. Measurements will be checked at least weekly by practice nurses who will contact the patients to adjust therapy according to guidelines and reinforce lifestyle advice. Participants in the control group will receive usual care. All participants will receive an individual education session.
Follow-up: measurements will be performed at practices 9 months after randomization by research nurses blinded to allocation. The primary outcome measure is HbA1c and secondary outcomes measure are daytime systolic and diastolic blood pressure, weight and cost per quality-adjusted life year.
Analysis: intention-to-treat analyses will be performed. The sample size of 320 participants allows for 20% drop-out and has 80% power at 5% significance to detect a 0.5% absolute (6 mmol/mol) fall in HbA1c in the intervention group. The qualitative study will explore the experiences of patients and professionals using the intervention.
Trial registration number ISRCTN71674628