Clinical trial NCT05883267: Virtual Reality and Children With Type 1 Diabetes
Official title: Virtual Reality's Impact on Children With Type 1 Diabetes: a Randomized Cross-over Trial on Anxiety, Pain, Adherence, and Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Children will be randomized to one of two interventions for diabetes management: group 1 will use VR glasses first and group 2 will listen to vocal-guided affective imagery first (audio). After 1 month, the interventions will be crossed over.
Primary purpose: SUPPORTIVE_CARE

Brief summary: For children with type 1 diabetes (T1D), pain and needle phobia can cause postponing of changes in insulin pump infusion sets and continuous glucose monitors, and thus worsen glycemic control. We aim to assess the effectiveness of virtual reality (VR) technology, in reducing pain and anxiety, and improving regimen adherence and glycemic control among children with type 1 diabetes (T1D).

Children with T1D, managed with continuous glucose monitoring and insulin pumps, will be recruited for a randomized cross-over trial. Children will be randomized to one of two interventions for diabetes management: group 1 will use VR glasses first and group 2 will listen to vocal-guided affective imagery first (audio). After 1 month, the interventions will be crossed over. The outcome measures will include pain and anxiety assessment, regimen adherence, glycemic control, and patient-reported outcome measures (PROMs) of VR satisfaction and effectiveness.

Detailed description: Children with T1D aged 8 to 15 years old, managed with CGM and insulin pumps, will be screened for participation. Key exclusion criteria include medical conditions that precluded use of the VR tool, such as epilepsy or vertigo, and diagnosed anxiety disorder.

Children will be randomly assigned (1:1 ratio) to one of the two groups. Upon every change of a CGM or pump infusion set, parents will be instructed to actively coach the child to use the designated intervention, VR glasses, or vocal-guided affective imagery, during the entire procedure. The VR glasses will be "PICO" model neo 2. The visual and vocal data content include both calming, affective imagery and interactive gaming, supplied by "XR-Health Israel Ltd". The vocal-guided affective imagery during the procedure will be identical to the vocal guide in the VR glasses. We plan 40 children in each group. The study will last for 2 months.

Questionnaires to assess anxiety and pain will be given to the children at baseline, during every CGM / pump infusion set change (every 3-14 days, depending on the device), and at one and two months after study initiation. Regimen adherence will be measured by changes in the number of insertion sites on the participants' bodies and by their willingness to change CGM / pump infusion sets themselves. Questionnaires administered at baseline, one month, and two months after the intervention will assess the use of aiding measures. Glycemic control measures that will be measured are comprised of differences between the interventions, in the percentage of time in range (TIR) 70-180 mg/dL, the percentage of time below range I (TBRI) \<70 mg/dL and TBRII \<54 mg/dL, the percentage of time above range I (TARI) \>180 mg/dL andTARII \>250 mg/dL, estimated HbA1c as measured by glucose management indicator (GMI), mean glucose, standard deviation, and the coefficient of variation (CV). A questionnaire that will assess the effectiveness and satisfaction of VR, and will evaluate the relief of diabetes distress following the intervention will be given at baseline, 1 and 2 months after the beginning.

Eligibility criteria: Inclusion Criteria:

• Children and young adults aged 8-15 years with type 1 diabetes with continuous glucose monitoring (CGM) and insulin pump.

Exclusion Criteria:

* Children with medical conditions not able to use virtual reality tool, such as epilepsy or vertigo.
* Children with diagnosed anxiety disorder who are treated with medications.

Primary outcomes:
measure: Pain assessment
timeFrame: At baseline, during every CGM/ pump infusion set change (every 3-14 days, depending on the device), and at one and two months after study initiation.
measure: Anxiety assessment - state anxiety
timeFrame: At baseline, during every CGM/ pump infusion set change (every 3-14 days, depending on the device), and at one and two months after study initiation.
measure: Anxiety assessment - trait anxiety
timeFrame: Baseline and 2 months after the intervention
Secondary outcomes:
measure: Regimen adherence
timeFrame: Baseline, 1 month and 2 months after the intervention
measure: Glycemic control measures - percentage of time in range 70-180 mg/dL
timeFrame: Baseline, 1 month and 2 months after the intervention
measure: Glycemic control measures - percentage of time below range <70 mg/dL
timeFrame: Baseline, 1 month and 2 months after the intervention
measure: Glycemic control measures - percentage of time below range <54 mg/dL
timeFrame: Baseline, 1 month and 2 months after the intervention
measure: Glycemic control measures - percentage of time above range I >180 mg/dL
timeFrame: Baseline, 1 month and 2 months after the intervention
measure: Glycemic control measures - percentage of time above range >250 mg/dL
timeFrame: Baseline, 1 month and 2 months after the intervention
measure: Glycemic control measures - estimated HbA1c as measured by glucose management indicator (GMI)
timeFrame: Baseline, 1 month and 2 months after the intervention
measure: Glycemic control measures - mean glucose
timeFrame: Baseline, 1 month and 2 months after the intervention
measure: Glycemic control measures - standard deviation
timeFrame: Baseline, 1 month and 2 months after the intervention
measure: Glycemic control measures - coefficient of variation (CV)
timeFrame: Baseline, 1 month and 2 months after the intervention
measure: VR Satisfaction and effectiveness assessment
timeFrame: Baseline, 1 month and 2 months after the intervention
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Noah Gruber
state: Please Select
Study officials:
affiliation: Sheba Medical Center
name: Noah Gruber, MD
role: PRINCIPAL_INVESTIGATOR
References: