Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/04/2008
Date assigned
12/02/2009
Last edited
10/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kenneth Earle

ORCID ID

Contact details

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

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 measures

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

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

http://www.motorola.com/

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20597833

Publication citations

  1. 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.

Additional files

Editorial Notes