Topic: Diabetes Research Network, Primary Care Research Network for England, Scottish Primary Care Research Network and Scottish Diabetes Research network
Conditions
Interventions
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
Follow Up Length: 9 month(s)
Study Entry : Single Randomisation only
Sponsors
University of Edinburgh (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in mean HbA1c between intervention and control groups; Timepoint(s): 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed