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

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ClinicalTrials.gov Identifier: NCT03505268
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Zohar Landau, Assuta Hospital Systems

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE April 23, 2018
Last Update Posted Date April 23, 2018
Estimated Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes
Official Title  ICMJE The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Telemedicine
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 3, 2019
Estimated Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zohar Landau, MD +97235028420 landau.zohar@gmail.com
Contact: Neriya Levran, RD +972545432176 neriyale@gmail.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03505268
Other Study ID Numbers  ICMJE 2016033
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zohar Landau, Assuta Hospital Systems
Study Sponsor  ICMJE Assuta Hospital Systems
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zohar Landau, MD Assuta Hospital Systems
PRS Account Assuta Hospital Systems
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP