The impact of a telemetric monitoring service in type 2 diabetes
| ISRCTN | ISRCTN71674628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71674628 |
| Protocol serial number | 9556 |
| Sponsor | University of Edinburgh (UK) |
| Funder | Chief Scientist Office (ref: ARPG/07/03) |
- Submission date
- 06/05/2011
- Registration date
- 06/05/2011
- Last edited
- 20/09/2016
- 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
Mrs Mary Paterson
Scientific
Scientific
Trial Manager
Room 216b, Doorway 3
Centre for Population Health Sciences: GP Section
The University of Edinburgh
Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
| Mary.Paterson@ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Process of Care |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The impact of a telemetric monitoring service in type 2 diabetes: a randomised controlled trial |
| Study acronym | Telescot Diabetes Study |
| Study objectives | As the population ages, more people are living with long term conditions. Current methods of management, relying on clinicians to monitor patients, are becoming unsustainable. There is potential for people to monitor their own condition with appropriate supervision and support, but so far there is little good evidence that this helps them achieve better control. Systems are now available which allow patients with diabetes to monitor their own illnesses and automatically send the information to a secure website, which they and their clinicians can view. The system can provide reminders to take measurements and medication, and alert patients and clinicians if additional treatment is required. Aim: We want to find out if a telemetry system can help reduce blood glucose, blood pressure and weight of diabetics who have poor control of their symptoms. We also wish to find out if telemetry can help improve the quality of life of diabetics, and save patients and their clinicians' time. Method: We will do this by running a randomised controlled trial in which patients whose diabetes is poorly controlled are randomised to one of two groups: one group who get the telemetry (the intervention group) and the other group who continue to receive their usual care (the control group). We will collect data at the start and at the end of the study to see if those in the intervention group are better able to control and manage their diabetes with the supported self monitoring which telemetry provides. Potential benefits: Diabetes affects an increasing number of people, with large numbers having problems controlling their blood glucose levels and blood pressure. This is responsible for a heavy workload in primary care. We believe that telemetry has the potential to improve the quality of life for diabetics; however before equipment is purchased it is vital that the potential benefits are assessed. |
| Ethics approval(s) | South East Scotland Research Ethics Committee 2, First MREC approval date 25/11/2010, ref: 10/S1102160 |
| Health condition(s) or problem(s) studied | Topic: Diabetes Research Network, Primary Care Research Network for England, Scottish Primary Care Research Network and Scottish Diabetes Research network ; Subtopic: Not Assigned; Disease: Diabetes |
| Intervention | The control group do not receive an intervention other than an appointment at the beginning for optimisation of care and self management education. Telemetric monitoring: Patients in the intervention group will be given blood pressure (BP) and blood glucose monitors and weighing scales which use Bluetooth to transmit readings via a (supplied) modem to a remote server. The user may securely access their record on the server at any time (either at home if they have internet access, or in a library or other public internet access point). Their general practitioner (GP) and practice nurse will also be able to access this record via the internet. Users will also receive regular (monthly) feedback; Follow Up Length: 9 month(s); Study Entry : Single Randomisation only |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Difference in mean HbA1c between intervention and control groups; Timepoint(s): 9 months |
| Key secondary outcome measure(s) |
1. Difference in mean daytime diastolic BP measured by Ambulatory Blood Pressure Monitoring (ABPM); Timepoint(s): 9 months |
| Completion date | 30/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 320 |
| Key inclusion criteria | Patients registered with general practices in the selected areas who: 1. Are on their practice diabetes registers 2. Have type 2 diabetes which is managed mainly in general practice 3. Are aged bewteen 18 and 79 years 4. Have a last recorded haemoglobin A1c (HbA1c) measurement > 7.5% (>59 mmol/mol) 5. Have a last recorded blood pressure > 135/80mmHg and average daytime self monitored systolic blood pressure >1 30/75 mmHg 6. Have given informed consent 7. Have a mobile telephone signal available from home.; Target Gender: Male & Female; Upper Age Limit 79 years ; Lower Age Limit 18 years |
| Key exclusion criteria | Patients who: 1. Are aged 80 and above 2. Have an average systolic blood pressure =120/70 or > 210/135 mmHg taken by the research nurse at the consent visit 3. Have HbA1c < 7.5% (< 59 mmol/mol) 4. Have hypertension or renal disease being managed in secondary care 5. Have had treatment for a cardiac event, or other life-threatening illness within the past 6 months or have had surgery within the last 3 months 6. Are unable to consent 7. Are unable to use self-monitoring equipment; 8. Have atrial fibrillation 9. Are pregnant |
| Date of first enrolment | 01/03/2011 |
| Date of final enrolment | 30/11/2011 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
The University of Edinburgh
Edinburgh
EH8 9AG
United Kingdom
EH8 9AG
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 | 23/12/2015 | Yes | No | |
| Results article | results | 26/07/2016 | Yes | No | |
| Protocol article | protocol | 06/07/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/09/2016: Publication reference added.
28/07/2016: Publication reference added.
