Monthly Video-Consultation for Children With Type 1 Diabetes Using a Continuous Glucose Monitoring System: Design of ViDiKi, a Multimethod Intervention Study to Evaluate the Benefit of Telemedicine.
Adolescent
Blood Glucose
/ analysis
Blood Glucose Self-Monitoring
/ instrumentation
Child
Child, Preschool
Diabetes Mellitus, Type 1
/ blood
Female
Glycated Hemoglobin
/ analysis
Humans
Hypoglycemic Agents
/ therapeutic use
Infant
Insulin
/ therapeutic use
Insulin Infusion Systems
Male
Quality of Life
Telemedicine
children and adolescents
continuous glucose monitoring (CGM)
health-economic analysis
telemedicine
type 1 diabetes
video-consultation
Journal
Journal of diabetes science and technology
ISSN: 1932-2968
Titre abrégé: J Diabetes Sci Technol
Pays: United States
ID NLM: 101306166
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
pubmed:
19
7
2019
medline:
25
6
2021
entrez:
19
7
2019
Statut:
ppublish
Résumé
The introduction of continuous glucose monitoring (CGM) implies new challenges for diabetes care. As CGM systems are often directly linked to a web-based software solution, structured telemedicine care using a video-consultation may be a new option for families who care for children with type 1 diabetes mellitus (T1DM). "ViDiKi" (Virtual Diabetes Outpatient Clinic for Children and Youth) is a multicenter controlled trial carried out in Northern Germany. ViDiKi will examine if monthly telemedical consultations, in addition to regular care, will improve glycemic control and psychosocial outcomes. The primary outcome is glycemic control as measured by a change in glycated hemoglobin (HbA1c). A total of 240 participants aged between one year and 16 years using a CGM with multiple daily injections (MDI) or insulin pump therapy were recruited and assigned to a starter group or a six-month waiting control group. The sample size is designed to detect a between-group difference of 0.5% in HbA1c change at six months. Secondary outcomes are variability of blood glucose, health-related quality of life, self-efficacy, and satisfaction with telemedicine. To gain deeper insight into the experience of using telemedicine, qualitative interviews will be conducted. In a health-economic analysis, the costs of telemedicine and a cost-of-care analysis will be calculated. The results from the ViDiKi study shall give important information on the feasibility and putative benefits of telemedicine in children with T1DM and their caregivers. DRKS00012645.
Sections du résumé
BACKGROUND
The introduction of continuous glucose monitoring (CGM) implies new challenges for diabetes care. As CGM systems are often directly linked to a web-based software solution, structured telemedicine care using a video-consultation may be a new option for families who care for children with type 1 diabetes mellitus (T1DM).
METHODS
"ViDiKi" (Virtual Diabetes Outpatient Clinic for Children and Youth) is a multicenter controlled trial carried out in Northern Germany. ViDiKi will examine if monthly telemedical consultations, in addition to regular care, will improve glycemic control and psychosocial outcomes. The primary outcome is glycemic control as measured by a change in glycated hemoglobin (HbA1c). A total of 240 participants aged between one year and 16 years using a CGM with multiple daily injections (MDI) or insulin pump therapy were recruited and assigned to a starter group or a six-month waiting control group. The sample size is designed to detect a between-group difference of 0.5% in HbA1c change at six months. Secondary outcomes are variability of blood glucose, health-related quality of life, self-efficacy, and satisfaction with telemedicine. To gain deeper insight into the experience of using telemedicine, qualitative interviews will be conducted. In a health-economic analysis, the costs of telemedicine and a cost-of-care analysis will be calculated.
CONCLUSIONS
The results from the ViDiKi study shall give important information on the feasibility and putative benefits of telemedicine in children with T1DM and their caregivers.
GERMAN CLINICAL TRAILS REGISTER (DRKS)
DRKS00012645.
Identifiants
pubmed: 31315446
doi: 10.1177/1932296819861991
pmc: PMC7189148
doi:
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin
0
Banques de données
DRKS
['DRKS00012645']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
105-111Références
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