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
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Behavioral: Telemedicine||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes|
|Estimated Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||May 3, 2019|
|Estimated Study Completion Date :||May 3, 2019|
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.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505268
|Contact: Zohar Landau, MDfirstname.lastname@example.org|
|Contact: Neriya Levran, RDemail@example.com|
|Tel Aviv, Israel|
|Contact: Zohar Landau, MD +972544822792 firstname.lastname@example.org|
|Principal Investigator:||Zohar Landau, MD||Assuta Hospital Systems|