Intensified Insulin Therapy With Telemedicine

Not Applicable

• Conditions: Intensified Insulin Therapy; Diabetes
• Interventions: Device: Telemedicine system users

• Registration Number: NCT05100576
• Lead Sponsor: Szeged University

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.

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-19
• Last Update Submitted: 2021-10-19
• Study First Posted: 2021-10-29
• Last Update Posted: 2021-10-29
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active group	Telemedicine system users	This group gets the telemedicine system, with the devices, and gets life-style guide by telephone consultation/ visits, during 3 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Szeged; 🇭🇺 Szeged, Hungary