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
Highlights
Diabetes prevalence is increasing and current methods of management are unsustainable
Building on existing literature [17,25,26], and in an iterative process using insights from completed and on-going exploratory and pilot work [27], we have designed several complementary Phase III randomized controlled trials. These will evaluate how telemetry-aided, supervised self-monitoring affects the management of long-term conditions in four different contexts
This paper describes the protocol for the latter trial in which the aim 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 a single education session in addition to usual care
Summary
The prevalence of diagnosed diabetes is increasing across the world and, in Scotland, has increased from 3.9% to 4.7% in people of all ages between 2006 and 2011 according to the annual Diabetes Survey [1]. Systematic reviews indicate that engaging patients in self-monitoring and management can improve clinical outcomes in asthma [7] but the evidence that self-monitoring alone is beneficial in people with type 2 diabetes [8] is less clear. Building on existing literature [17,25,26], and in an iterative process using insights from completed and on-going exploratory and pilot work [27], we have designed several complementary Phase III randomized controlled trials These will evaluate how telemetry-aided, supervised self-monitoring affects the management of long-term conditions in four different contexts (largely asymptomatic conditions using the example of hypertension; symptomatic, potentially unstable and progressive conditions using the example of chronic obstructive pulmonary disease; an older, more disabled group with challenging management targets using the example of hypertension among stroke survivors; co-morbid conditions using the example of diabetes, hypertension and weight management). This paper describes the protocol for the latter trial in which the aim 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 a single education session in addition to usual care
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