ISRCTN14900339
Completed
未知
Pilot for interventional diabetes self-management education service
Optimum Health Innovations Ltd0 sites12 target enrollmentMay 31, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Optimum Health Innovations Ltd
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged \=18\-75 years old
- •2\. A confirmed diagnosis of T2DM within the last year treated by metformin and/or lifestyle
- •3\. A body mass index of 22\-45 kg/m2
- •4\. Willingness to undertake a structured education programme for 6 weeks
- •5\. Willingness to attend the course venue at specified times on 6 separate occasions
- •6\. Ability to read, write and converse in English without the support of an interpreter
- •7\. Familiar with internet and Smartphone use and with regular access to a connected computer
Exclusion Criteria
- •1\. Inability to provide informed consent
- •2\. Unwillingness or inability to perform any of the study components required, specifically self\-monitoring of blood glucose (finger\-stick SMBG) or oral glucose tolerance test (OGTT)
- •3\. Any contra\-indication for weight loss
- •4\. Type 1 diabetes mellitus (T1DM) or diagnosed with T2DM \> 1 years
- •5\. Currently prescribed insulin, thiazolidenediones or sulfonylurea.
- •6\. Currently prescribed steroids or beta\-blockers
- •7\. Serum Creatinine \> 150mmol/L
- •8\. Serum ALT greater than 2\.5 times the upper limit of the reference range
- •9\. Pregnant or intending to become pregnant
- •10\. HF or any other existing cardiovascular co\-morbidity
Outcomes
Primary Outcomes
Not specified
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