Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05/Q0803/128
Study information
Scientific title
Randomised parallel group controlled trial of real-time telemonitoring (RTTM) versus conventional care in the management of glycaemia and blood pressure in patients with diabetes mellitus
Acronym
Study hypothesis
Randomised parallel group controlled trial of real-time telemonitoring (RTTM) versus conventional care in the management of glycaemia and blood pressure in patients with diabetes mellitus.
Ethics approval
Wandsworth Local Research Ethics Committee, St George's Hospital gave approval on the 26th September 2005 (ref: 05/Q0803/128)
Study design
Randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes mellitus
Intervention
This study is a randomised controlled trial. Patients will be recruited from the diabetes clinic at St George's Hospital to obtain consents. In the initial visit the demographic and the clinical data are collected in a standard proformas. The patients are then invited for a second visit to be randomised to either RTTM or conventional care.
The patients in the RTTM group are trained on how to self-monitor their blood glucose and weekly blood pressure using devices to transmit the data wirelessly via a mobile phone to a central server in St George's Hospital which are viewed by clinicians using a web-based tool.
The patients in the conventional care (control) group will receive their management entirely from their general practitioner and/or practice nurse in the community.
All patients from both groups will be invited for reassessment of baseline parameters after 6 months at St George's Hospital by the researcher.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Improvement of blood pressure, measured at baseline and 6 months
2. Good diabetes control, measured at baseline and 6 months
Secondary outcome measures
No secondary outcome measures.
Overall trial start date
01/06/2006
Overall trial end date
01/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Ambulant male and females over 18 years of age
2. Diabetes mellitus
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Pregnancy
2. Malignany
Recruitment start date
01/06/2006
Recruitment end date
01/06/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Thomas Addison Diabetes Unit
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
Motorola Inc. (USA)
Sponsor details
c/o Mr Jorge Perdomo
Delaware Corporation
8000 W. Sunrise Boulevard
Plantation
Florida
FL 33322
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Motorola Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20597833
Publication citations
-
Results
Earle KA, Istepanian RS, Zitouni K, Sungoor A, Tang B, Mobile telemonitoring for achieving tighter targets of blood pressure control in patients with complicated diabetes: a pilot study., Diabetes Technol. Ther., 2010, 12, 7, 575-579, doi: 10.1089/dia.2009.0090.