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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03505268
Enrollment
75
Registered
2018-04-23
Start date
2018-05-01
Completion date
2019-05-03
Last updated
2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Glycosylated hemoglobin A1c (HbA1c), Telemedicine

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 ,

Interventions

BEHAVIORALTelemedicine

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.

Sponsors

Assuta Hospital Systems
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 13 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
The impact of telehealthcare intervention on the change of the glycemic control in children with type 1 diabetes6 monthsThe glycemic control will be measured by the change from baseline Glycosylated hemoglobin A1c (HbA1c) at 6 months.

Countries

Israel

Contacts

Primary ContactZohar Landau, MD
landau.zohar@gmail.com+97235028420
Backup ContactNeriya Levran, RD
neriyale@gmail.com+972545432176

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026