Intensified Insulin Therapy With Telemedicine

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100576
• Other study ID #: TMED_INZULIN_001
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: October 2021
• Source: Szeged University
• Contact: István Kósa, Md Ph.D.
• Phone: +36 70 320 1192
• Email: office.prevmedicina[@]med.u-szeged.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Telemedicine system users
Telemonitoring by medical devices connected to a software system with a router.

Locations

Country	Name	City	State
Hungary	University of Szeged	Szeged

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Safety of the device system	3 months
Secondary	change of hypoglycemic episodes	Number of hypoglycemic episodes	3 months
Secondary	Difference in the decisions between the two type of visits	Consistency of investigators' decisions based on telemedicine data and personal visit	3 months