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

Study 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 ,

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

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Telemedicine


Participation Criteria
=================
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 -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telemedicine intervention<br>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<br>* 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.<br>|
| No Intervention: usual care<br>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 | The glycemic control will be measured by the change from baseline Glycosylated hemoglobin A1c (HbA1c) at 6 months. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycosylated hemoglobin A1c (HbA1c), Telemedicine