Intensified Insulin Therapy With Telemedicine

Study Overview
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Brief Summary
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Investigation of the effect of a 3-month telemedicine-led lifestyle intervention in individuals requiring intensified insulin therapy.

Detailed Description
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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.

Official Title
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Randomized Controlled Clinical Trial of Telemedicine-guided Lifestyle Intervention in Diabetic Patients During Intensive Insulin Therapy.

Conditions
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Intensified Insulin Therapy, Diabetes

Intervention / Treatment
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* Device: Telemedicine system users


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active group<br>This group gets the telemedicine system, with the devices, and gets life-style guide by telephone consultation/ visits, during 3 months | Device: Telemedicine system users<br>* Telemonitoring by medical devices connected to a software system with a router.<br>|
| No Intervention: Comparator group<br>This group gets the normal, evidence based therapy, without extra visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine