Real-time telemonitoring (RTTM) versus conventional care in the management of glycaemia and blood pressure in diabetic patients

ISRCTN ISRCTN86323184
DOI https://doi.org/10.1186/ISRCTN86323184
Secondary identifying numbers 05/Q0803/128
Submission date
29/04/2008
Registration date
12/02/2009
Last edited
10/11/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kenneth Earle
Scientific

Thomas Addison Diabetes Unit
St George's Hospital NHS Trust
Blackshaw Road
London
SW17 0QT
United Kingdom

Study information

Study designRandomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised 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
Study objectivesRandomised 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(s)Wandsworth Local Research Ethics Committee, St George's Hospital gave approval on the 26th September 2005 (ref: 05/Q0803/128)
Health condition(s) or problem(s) studiedDiabetes mellitus
InterventionThis 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 typeOther
Primary outcome measure1. Improvement of blood pressure, measured at baseline and 6 months
2. Good diabetes control, measured at baseline and 6 months
Secondary outcome measuresNo secondary outcome measures.
Overall study start date01/06/2006
Completion date01/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants200
Key inclusion criteria1. Ambulant male and females over 18 years of age
2. Diabetes mellitus
Key exclusion criteria1. Pregnancy
2. Malignany
Date of first enrolment01/06/2006
Date of final enrolment01/06/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Thomas Addison Diabetes Unit
London
SW17 0QT
United Kingdom

Sponsor information

Motorola Inc. (USA)
Industry

c/o Mr Jorge Perdomo
Delaware Corporation
8000 W. Sunrise Boulevard
Plantation
Florida
FL 33322
United States of America

Website http://www.motorola.com/
ROR logo "ROR" https://ror.org/01hafxd32

Funders

Funder type

Industry

Motorola Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2010 Yes No