The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes

April 12, 2018 updated by: Zohar Landau, Assuta Hospital Systems

This study evaluates the effect of telemedicine intervention program upon glycemic control in type 1 diabetes mellitus children and their parents in Israel. Half of the participants will receive the telemedicine intervention for a period of six months while the other half will receive the regular treatment then vice versa. Each group will receive in the intervention period 6 telemedicine meeting with a dietician and six telemedicine meetings with a nurse.

The investigators hypothesized that the participants that are recieving the telemedicine intervention will have a better glycemic control after 6 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prevalence of type 1 diabetes has been steadily increasing for the past few decades and is a relatively common chronic disease of childhood (1). Managing type 1 diabetes in young children presents unique challenges to the patient, parents, and to the pediatric health care provider. The diabetes regimen includes intensive blood glucose monitoring, multiple daily injections of insulin ,and frequent insulin dose adjustments according to the amount of carbohydrate eaten, blood sugar, and physical activity. The Diabetes Control and Complications Trail (DCCT) showed a significant link between blood glucose control and a slower onset and progression of diabetes complications, with improved glycemic control decreasing the risk of micro- and macro- vascular complication (2,3,4).

Glycosylated hemoglobin A1c (HbA1c) measures the

In the past decade a significant progress took place in therapy and treatment of diabetes. However poor glycemic control is recorded in a significant proportion of adolescents.

Telehealthcare is the use of telecommunications to deliver healthcare services and involves the remote interaction between a primary care provider and specialist. Telemedicine represents a useful and cost-effective solution to the strict follow-up required in diabetes management ,

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

diagnosed with typ1 1 diabetes for at least 6 months insulin dependent participants provided consent to participate in the study consent to use the Accu-Chek Connect diabetes management app -

Exclusion Criteria:

new onset of diabetes type 1 not specified as type 1 diabetes

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: telemedicine intervention
The intervention group, in addition to usual care, will get 10 telemedicine interventions by a certified nurse and dietitian who both specialize in treatment of type 1 diabetes.
Behavioral: Telemedicine
Patients of the Intervention Group will have once biweekly telephonic intervention conversation with dietitian, specialized in diabetes and diabetes nurse. The patients of the control group will have a routine care.
No Intervention: usual care
Usual care consisted of visits to the diabetes center every three months and communication with their doctor by phone when needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of telehealthcare intervention on the change of the glycemic control in children with type 1 diabetes
Time Frame: 6 months
The glycemic control will be measured by the change from baseline Glycosylated hemoglobin A1c (HbA1c) at 6 months.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Hospital Systems

Investigators

  • Principal Investigator: Zohar Landau, MD, Assuta Hospital Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

May 3, 2019

Study Completion (Anticipated)

May 3, 2019

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016033

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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