Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/05/2011
Date assigned
06/05/2011
Last edited
20/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.telescot.org/diabetes.html

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 measures

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

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

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes

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