Intensified Insulin Therapy With Telemedicine

NCT ID: NCT05100576

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Intensified Insulin Therapy Diabetes

Keywords

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telemedicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Active group

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

Group Type EXPERIMENTAL

Telemedicine system users

Intervention Type DEVICE

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

Comparator group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telemedicine system users

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Szeged University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Szeged

Szeged, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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István Kósa, Md Ph.D.

Role: CONTACT

Phone: +36 70 320 1192

Email: [email protected]

Facility Contacts

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István Kósa, MD Ph.D.

Role: primary

Other Identifiers

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TMED_INZULIN_001

Identifier Type: -

Identifier Source: org_study_id