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

NCT ID: NCT03505268

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-05-03

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 ,

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telemedicine

Intervention Type: BEHAVIORAL

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.

usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

-

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assuta Hospital Systems

OTHER

Sponsor Role: lead

Responsible Party

Zohar Landau

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zohar Landau, MD

Role: PRINCIPAL_INVESTIGATOR

Assuta Hospital Systems

Locations

AssutaHA

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Zohar Landau, MD

Role: CONTACT

landau.zohar@gmail.com

+97235028420

Neriya Levran, RD

Role: CONTACT

neriyale@gmail.com

+972545432176

Facility Contacts

Zohar Landau, MD

Role: primary

landau.zohar@gmail.com

+972544822792

References

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.

Reference Type: RESULT

PMID: 23340893 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18779236 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20648399 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19643436 (View on PubMed)

Other Identifiers

2016033

Identifier Type: -

Identifier Source: org_study_id