Intensified Insulin Therapy With Telemedicine

Sponsor

Szeged University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05100576

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intensified Insulin Therapy Diabetes	Device: Telemedicine system users	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active group 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 Telemonitoring by medical devices connected to a software system with a router.
No Intervention: Comparator group This group gets the normal, evidence based therapy, without extra visits.

Arm

Intervention/Treatment

Experimental: Active group

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

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

No Intervention: Comparator group

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Szeged	Szeged		Hungary	6720

Sponsors and Collaborators

Szeged University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Szeged University

ClinicalTrials.gov Identifier:

NCT05100576

Other Study ID Numbers:

TMED_INZULIN_001

First Posted:

Oct 29, 2021

Last Update Posted:

Oct 29, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Szeged University

telemedicine

Study Results

No Results Posted as of Oct 29, 2021