TY - JOUR
T1 - Outcomes of monthly video consultations as an add-on to regular care for children with type 1 diabetes: A 6-month quasi-randomized clinical trial followed by an extension phase
AU - von Sengbusch, Simone
AU - Eisemann, Nora
AU - Mueller-Godeffroy, Esther
AU - Lange, Karin
AU - Doerdelmann, Jana
AU - Erdem, Alev
AU - Menrath, Ingo
AU - Bokelmann, Jessica
AU - Krasmann, Miriam
AU - Kaczmarczyk, Patrizia
AU - Bertram, Bettina
AU - Hiort, Olaf
AU - Katalinic, Alexander
AU - Frielitz, Fabian S.
N1 - Funding Information:
Over the past two decades, the treatment options for children and adolescents with type 1 diabetes mellitus (T1DM) have improved substantially with the introduction of insulin pumps, insulin analogs, and continuous glucose monitoring (CGM) systems. Children with T1DM should visit a diabetes outpatient clinic at least once every 3 months, or more often if difficulties arise, for CGM, glucose and insulin data analysis, insulin adjustments, a physical examination, laboratory assessment and an assessment of well‐being. The time and organizational effort required for families to visit the outpatient clinic is often high, especially in rural areas, leading to demotivation and economic constraints on the family and even missed appointments. In contrast, a short consultation is often sufficient to jointly analyze the CGM and insulin data with the health care professional (HCP) and to initiate a change in insulin therapy, if necessary. Video consultations as a replacement for or as a supplement to outpatient appointments for children and adolescents with T1DM are increasingly being tested in studies. Video consultation is still rarely offered in the German health service until recently; however, a need was already apparent for rural areas and specialist medical care. This study was financed by the Innovation Fund of the Federal Ministry of Health, because video consultation was identified as a promising form of future medical care, especially in specialist areas such as diabetology. 1 2‐4
Funding Information:
The authors would like to thank the participating families who generously contributed their views to the study. The authors would also like to thank all VIDIKI consortium partners: The health insurance AOK NORDWEST, the General Hospital Kiel, and the University of Lübeck, and the cooperating health insurance groups (in alphabetical order): Barmer, BKK Atlas‐Ahlmann, BKK Deutsche Bank, BKK Diakonie, BKK Energie, BKK Melitta Plus, BKK Mobil Oil, BKK Novitas, BKK Verbund Plus, BKK Viactiv, DAK, IKK Berlin‐Brandenburg, IKK Nord, SVLFG, and TK. We thank all diabetes centers and diabetologists from Schleswig‐Holstein and the two specialized pediatric diabetes centers in Hamburg for referring their patients to the study and allowing telemedical cotreatment. The VIDIKI study was funded by the German Federal Joint Committee (Funding Code 01NVF16023).
Publisher Copyright:
© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/12/1
Y1 - 2020/12/1
N2 - Objective: To explore the outcomes of monthly video consultations for children with diabetes. Methods: The Virtual Outpatient Diabetes Clinic for Children and Youth (VIDIKI) was a 6-month multicenter controlled clinical trial followed by an extension phase. The 240 participants (1-16 years), all using a CGM, were quasi-randomized by residence location to the intervention group (IG) or the waitlist-control group (WG). The IG started immediately after enrollment with monthly video consultations as an add-on to regular care, while the WG received regular care for 6 months before starting the intervention. The extension phase lasted between 12 months and 2 years, depending on the enrollment date. Linear regression was applied to model the primary outcome of HbA1c after 6 months and other metabolic and psychosocial outcomes. Results: After covariate adjustments, the HbA1c at 6 months—corresponding to the controlled treatment phase—was 0.11% lower in the IG than that in the WG (95% CI −0.31 to 0.09, P =.277). For the total study sample, a significant HbA1c improvement was found after 12 months of video consultations, which increased further until month 15. The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG. Conclusions: The VIDIKI study found no significant HbA1c difference between IG and WG after 6 months in the controlled phase, but there was a decreased diabetes burden and increased treatment satisfaction for the parents. In the longitudinal perspective, a significant HbA1c improvement was found after 12 and 15 months.
AB - Objective: To explore the outcomes of monthly video consultations for children with diabetes. Methods: The Virtual Outpatient Diabetes Clinic for Children and Youth (VIDIKI) was a 6-month multicenter controlled clinical trial followed by an extension phase. The 240 participants (1-16 years), all using a CGM, were quasi-randomized by residence location to the intervention group (IG) or the waitlist-control group (WG). The IG started immediately after enrollment with monthly video consultations as an add-on to regular care, while the WG received regular care for 6 months before starting the intervention. The extension phase lasted between 12 months and 2 years, depending on the enrollment date. Linear regression was applied to model the primary outcome of HbA1c after 6 months and other metabolic and psychosocial outcomes. Results: After covariate adjustments, the HbA1c at 6 months—corresponding to the controlled treatment phase—was 0.11% lower in the IG than that in the WG (95% CI −0.31 to 0.09, P =.277). For the total study sample, a significant HbA1c improvement was found after 12 months of video consultations, which increased further until month 15. The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG. Conclusions: The VIDIKI study found no significant HbA1c difference between IG and WG after 6 months in the controlled phase, but there was a decreased diabetes burden and increased treatment satisfaction for the parents. In the longitudinal perspective, a significant HbA1c improvement was found after 12 and 15 months.
UR - http://www.scopus.com/inward/record.url?scp=85092558043&partnerID=8YFLogxK
U2 - 10.1111/pedi.13133
DO - 10.1111/pedi.13133
M3 - Journal articles
C2 - 33009690
AN - SCOPUS:85092558043
SN - 1399-543X
VL - 21
SP - 1502
EP - 1515
JO - Pediatric diabetes
JF - Pediatric diabetes
IS - 8
ER -
