Randomized Controlled Clinical Trial of Telemedicine-guided Lifestyle Intervention in Diabetic Patients During Intensive Insulin Therapy.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intensified Insulin Therapy
- Sponsor
- Szeged University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change of HbA1c level
- Last Updated
- 4 years ago
Overview
Brief Summary
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention in individuals requiring intensified insulin therapy.
Detailed Description
The primary objective of this study was to evaluate the development of HbA1c levels in patients requiring 3 months of intensified insulin therapy using standard therapy and telemedicine devices currently in use. The telemedicine system contains a mobile phone-based nutrition diary, bluetooth-related wrist activity meter, weight scale, blood pressure monitor, blood glucose meter, and IT system for transmitting and displaying data from these devices.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women or men between the ages of 18 and 75
- •Patient with Diabetes who needs intensified insulin therapy HbA1c\> = 8%
- •IT proficiency is at least basic for cell phones (answering / making a voice call).
- •Signing a informed consent
- •For women with childbearing potential, by definition, all women who who are physiologically able to conceive are twofold use of contraception
- •The subject communicates well with the investigator and is able to perform the test to understand and help comply with the requirements of the protocol
Exclusion Criteria
- •informed refusal any time after the sign of the informed consent
- •Planned invasive cardiac intervention (catheter vasodilation or surgical coronary artery bypass grafting, keyboard surgery or replacement)
- •Tumor disease
- •Pregnant or lactating women
- •Any medical condition that does not allow participation
Outcomes
Primary Outcomes
Change of HbA1c level
Time Frame: 3 months
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on HbA1c levels in individuals requiring insulin therapy
Secondary Outcomes
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(3 months)
- change of hypoglycemic episodes(3 months)
- Difference in the decisions between the two type of visits(3 months)