Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Mary Paterson
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9556
Study information
Scientific title
The impact of a telemetric monitoring service in type 2 diabetes: a randomised controlled trial
Acronym
Telescot Diabetes Study
Study hypothesis
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
South East Scotland Research Ethics Committee 2, First MREC approval date 25/11/2010, ref: 10/S1102160
Study design
Randomised; Interventional; Design type: Process of Care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information material can be found at http://www.telescot.org/diabetes.html
Condition
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 names
Primary outcome measure
Difference in mean HbA1c between intervention and control groups; Timepoint(s): 9 months
Secondary outcome measures
1. Difference in mean daytime diastolic BP measured by Ambulatory Blood Pressure Monitoring (ABPM); Timepoint(s): 9 months
2. Difference in mean daytime systolic BP measured by ABPM; Timepoint(s): 9 months
3. Difference in mean weight between intervention and control groups; Timepoint(s): 9 months
4. Incremental cost-effectiveness measured as Cost per Quality Adjusted Life Year; Timepoint(s): 9 months
Overall trial start date
01/03/2011
Overall trial end date
30/11/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 320; UK Sample Size: 320
Participant 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
Recruitment start date
01/03/2011
Recruitment end date
30/11/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The University of Edinburgh
Edinburgh
EH8 9AG
United Kingdom
Sponsor information
Organisation
University of Edinburgh (UK)
Sponsor details
c/o Miss Gemma Watson
Research Governance Office
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 9461
researchgovernance@ed.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (ref: ARPG/07/03)
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
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
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23829417
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26700275
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27458809