Diabetes, Intensified Insulin Therapy
Conditions
Keywords
telemedicine
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.
Interventions
DEVICETelemedicine system users
Telemonitoring by medical devices connected to a software system with a router.
Sponsors
Szeged University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of HbA1c level | 3 months | Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on HbA1c levels in individuals requiring insulin therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 3 months | Safety of the device system |
| change of hypoglycemic episodes | 3 months | Number of hypoglycemic episodes |
| Difference in the decisions between the two type of visits | 3 months | Consistency of investigators' decisions based on telemedicine data and personal visit |
Countries
Hungary
Contacts
Primary ContactIstván Kósa, Md Ph.D.
Outcome results
None listed