Intensified Insulin Therapy With Telemedicine

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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Intensified Insulin Therapy
• Intervention / Treatment: Device: Telemedicine system users

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: István Kósa, MD Ph.D.; Phone Number: +36 70 320 1192; Email: office.prevmedicina@med.u-szeged.hu

Study Locations

• Hungary
  • Szeged, Hungary, 6720
    • Recruiting
    • University of Szeged
    • Contact: István Kósa, MD Ph.D.; Phone Number: +36 70 320 1192; Email: office.prevmedicina@med.u-szeged.hu
    • Principal Investigator: Csaba Lengyel, Prof.Dr.
    • Sub-Investigator: István Kósa, MD Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Szeged University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: telemedicine
• Other Study ID Numbers: TMED_INZULIN_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No