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Clinical Trials/NCT03505268
NCT03505268
Unknown
N/A

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

Assuta Hospital Systems1 site in 1 country75 target enrollmentMay 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
Assuta Hospital Systems
Enrollment
75
Locations
1
Primary Endpoint
The impact of telehealthcare intervention on the change of the glycemic control in children with type 1 diabetes
Last Updated
8 years ago

Overview

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 ,

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
May 3, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Assuta Hospital Systems
Responsible Party
Principal Investigator
Principal Investigator

Zohar Landau

Principal Investigator

Assuta Hospital Systems

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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