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Investigation of the effect of a 3-month telemedicine-led lifestyle intervention in individuals requiring intensified insulin therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Experimental | This group gets the telemedicine system, with the devices, and gets life-style guide by telephone consultation/ visits, during 3 months |
|
| Comparator group | No Intervention | This group gets the normal, evidence based therapy, without extra visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine system users | Device | Telemonitoring by medical devices connected to a software system with a router. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of HbA1c level | Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on HbA1c levels in individuals requiring insulin therapy | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Safety of the device system | 3 months |
| change of hypoglycemic episodes | Number of hypoglycemic episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| István Kósa, Md Ph.D. | Contact | +36 70 320 1192 | office.prevmedicina@med.u-szeged.hu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Szeged | Recruiting | Szeged | 6720 | Hungary |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 3 months |
| Difference in the decisions between the two type of visits | Consistency of investigators' decisions based on telemedicine data and personal visit | 3 months |