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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes Mellitus focused on measuring Glycosylated hemoglobin A1c (HbA1c), Telemedicine

Eligibility Criteria

1 Year - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • AssutaHARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

telemedicine intervention

usual care

Arm Description

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.

Usual care consisted of visits to the diabetes center every three months and communication with their doctor by phone when needed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2017
Last Updated
April 12, 2018
Sponsor
Assuta Hospital Systems
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1. Study Identification

Unique Protocol Identification Number
NCT03505268
Brief Title
The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes
Official Title
The Impact of Telehealthcare Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
May 3, 2019 (Anticipated)
Study Completion Date
May 3, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Hospital Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 ,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Glycosylated hemoglobin A1c (HbA1c), Telemedicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
telemedicine intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
usual care
Arm Type
No Intervention
Arm Description
Usual care consisted of visits to the diabetes center every three months and communication with their doctor by phone when needed.
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine
Intervention Description
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.
Primary Outcome Measure Information:
Title
The impact of telehealthcare intervention on the change of the glycemic control in children with type 1 diabetes
Description
The glycemic control will be measured by the change from baseline Glycosylated hemoglobin A1c (HbA1c) at 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zohar Landau, MD
Phone
+97235028420
Email
landau.zohar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Neriya Levran, RD
Phone
+972545432176
Email
neriyale@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zohar Landau, MD
Organizational Affiliation
Assuta Hospital Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
AssutaHA
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zohar Landau, MD
Phone
+972544822792
Email
landau.zohar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23340893
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 Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.
Results Reference
result
PubMed Identifier
18779236
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, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.
Results Reference
result
PubMed Identifier
20648399
Citation
Tonella P, Fluck 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. eCollection 2010.
Results Reference
result
PubMed Identifier
19643436
Citation
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.
Results Reference
result

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

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