The impact of a telemetric monitoring service in type 2 diabetes

Completed

• Conditions: 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; Nutritional, Metabolic, Endocrine; Type 2 diabetes

• Registration Number: ISRCTN71674628
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-06
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 320

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in mean HbA1c between intervention and control groups; Timepoint(s): 9 months

Secondary Outcome Measures

Name	Time	Method
1. Difference in mean daytime diastolic BP measured by Ambulatory Blood Pressure Monitoring (ABPM); Timepoint(s): 9 months<br>2. Difference in mean daytime systolic BP measured by ABPM; Timepoint(s): 9 months<br>3. Difference in mean weight between intervention and control groups; Timepoint(s): 9 months<br>4. Incremental cost-effectiveness measured as Cost per Quality Adjusted Life Year; Timepoint(s): 9 months