The impact of a telemetric monitoring service in type 2 diabetes

ISRCTN	ISRCTN71674628
DOI	https://doi.org/10.1186/ISRCTN71674628
Secondary identifying numbers	9556

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

Study website

Contact information

Mrs Mary Paterson
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

Email	Mary.Paterson@ed.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Process of Care
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information material can be found at http://www.telescot.org/diabetes.html
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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
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 study start date	01/03/2011
Completion date	30/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 320; UK Sample Size: 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

Scotland
United Kingdom

Study participating centre

The University of Edinburgh

Edinburgh
EH8 9AG
United Kingdom

Sponsor information

University of Edinburgh (UK)
University/education

c/o Miss Gemma Watson
Research Governance Office
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Phone	+44 (0)131 242 9461
Email	researchgovernance@ed.ac.uk
"ROR"	https://ror.org/01nrxwf90

Funders

Funder type

Government

Chief Scientist Office (ref: ARPG/07/03)
Government organisation / Local government

Alternative name(s): CSO
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	06/07/2013	Yes	No
Results article	results	23/12/2015	Yes	No
Results article	results	26/07/2016	Yes	No

Editorial Notes

20/09/2016: Publication reference added.
28/07/2016: Publication reference added.