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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03505268
• Other study ID #: 2016033
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2017
• Last updated: April 12, 2018
• Start date: May 1, 2018
• Est. completion date: May 3, 2019

Study information

• Verified date: April 2018
• Source: Assuta Hospital Systems
• Contact: Zohar Landau, MD
• Phone: +97235028420
• Email: landau.zohar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 ,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Israel	AssutaHA	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Jean AM, Hassoun A, Hughes J, Pomeranz C, Fennoy I, McMahon DJ, Oberfield SE. Utility of early insulin response and proinsulin to assess insulin resistance. J Pediatr. 2009 Dec;155(6):893-9. doi: 10.1016/j.jpeds.2009.06.002. Epub 2009 Jul 29. — View Citation

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, — View Citation

Tonella P, Flück CE, Mullis PE. Metabolic control of type 1 diabetic patients followed at the University Children's Hospital in Berne: have we reached the goal? Swiss Med Wkly. 2010 Jul 16;140:w13057. doi: 10.4414/smw.2010.13057. — View Citation

Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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