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 |
| Protocol serial number | 05/Q0803/128 |
| Sponsor | Motorola Inc. (USA) |
| Funder | Motorola Inc. (USA) |
- 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
Scientific
Thomas Addison Diabetes Unit
St George's Hospital NHS Trust
Blackshaw Road
London
SW17 0QT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
1. Improvement of blood pressure, measured at baseline and 6 months |
| Key secondary outcome measure(s) |
No secondary outcome measures. |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Ambulant male and females over 18 years of age 2. Diabetes mellitus |
| Key exclusion criteria | 1. Pregnancy 2. Malignany |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Thomas Addison Diabetes Unit
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
