Intensified Insulin Therapy With Telemedicine

Szeged University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Intensified Insulin Therapy Diabetes

Interventions

Telemedicine system usersDEVICE

Telemonitoring by medical devices connected to a software system with a router.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Szeged

Szeged, Hungary

RECRUITING

Outcomes

Primary Outcomes

Change of HbA1c level

Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on HbA1c levels in individuals requiring insulin therapy

Time frame: 3 months

Secondary Outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Safety of the device system

Time frame: 3 months

change of hypoglycemic episodes

Number of hypoglycemic episodes

Time frame: 3 months

Difference in the decisions between the two type of visits

Consistency of investigators' decisions based on telemedicine data and personal visit

Time frame: 3 months

Central Contacts

István Kósa, Md Ph.D.

CONTACT

+36 70 320 1192 office.prevmedicina@med.u-szeged.hu

Data from ClinicalTrials.gov

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