The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trialReport as inadecuate




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Trials

, 14:198

First Online: 06 July 2013Received: 09 April 2013Accepted: 24 June 2013DOI: 10.1186-1745-6215-14-198

Cite this article as: Wild, S., Hanley, J., Lewis, S. et al. Trials 2013 14: 198. doi:10.1186-1745-6215-14-198

Abstract

BackgroundDiabetes 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.

Methods-DesignDesign: 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 registrationTrial registration number ISRCTN71674628

KeywordsDiabetes Hypertension Glycaemic control Blood pressure Weight Self-management Telehealth AbbreviationsABPMAmbulatory blood pressure monitor

GPGeneral Practitioner

HbA1cglycosylated hemoglobin

NICENational Institute of Health and Clinical Excellence.

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Author: Sarah Wild - Janet Hanley - Stephanie Lewis - John McKnight - Lucy McCloughan - Paul Padfield - Mary Paterson - Hilary Pin

Source: https://link.springer.com/



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