Intensified Insulin Therapy With Telemedicine

University of Szeged (SZTE)

Status: Unknown

Conditions: Diabetes; Intensified Insulin Therapy

Treatments: Device: Telemedicine system users

Study type: Interventional

Funder types: Other

Identifiers

NCT05100576

TMED_INZULIN_001

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Active group

Experimental group

Description:

This group gets the telemedicine system, with the devices, and gets life-style guide by telephone consultation/ visits, during 3 months

Treatment:

Device: Telemedicine system users

Comparator group

No Intervention group

Description:

This group gets the normal, evidence based therapy, without extra visits.