Virtual Reality and Children With Type 1 Diabetes

NCT05883267 | Completed DMC

• 1 other identifier: SHEBA-21-816421-NG-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality

Outcome Measures

Primary Outcomes (3)

• Pain assessment

  Questionnaires to assess 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. Pain scale assessment (FACES scale) will be assessed. Range of scores for the pain scale is from 0-10. A higher number meaning worse pain.

  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.

• Anxiety assessment - state anxiety

  Questionnaires to assess anxiety 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. State anxiety will be assessed using the standardized Spielberger State-Trait Anxiety Inventory (STAI). State anxiety scores range from 6-24, with a higher number meaning higher anxiety.

  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.

• Anxiety assessment - trait anxiety

  Questionnaires to assess anxiety will be given to the children at baseline and at two months after study initiation. Trait anxiety will be assessed using the standardized Spielberger State-Trait Anxiety Inventory (STAI). Trait anxiety scores range from 20-80, a higher number meaning higher anxiety.

  Baseline and 2 months after the intervention

Secondary Outcomes (11)

• Regimen adherence

  Baseline, 1 month and 2 months after the intervention

• Glycemic control measures - percentage of time in range 70-180 mg/dL

  Baseline, 1 month and 2 months after the intervention

• Glycemic control measures - percentage of time below range <70 mg/dL

  Baseline, 1 month and 2 months after the intervention

• Glycemic control measures - percentage of time below range <54 mg/dL

  Baseline, 1 month and 2 months after the intervention

• Glycemic control measures - percentage of time above range I >180 mg/dL

  Baseline, 1 month and 2 months after the intervention

Study Arms (2)

Virtual reality

EXPERIMENTAL

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.

Device: Virtual reality glasses

Audio

ACTIVE COMPARATOR

The vocal-guided affective imagery during the procedure will be identical to the vocal guide in the VR glasses.

Device: Vocal-guided affective imagery

Interventions

Virtual reality glasses DEVICE

"PICO" model neo 2 VR glasses

Virtual reality

Vocal-guided affective imagery DEVICE

Audio via telephone

Audio

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Noah Gruber

Ramat Gan, Please Select, 5265601, Israel

Location

Related Publications (1)

• Gruber N, Shemesh-Iron M, Kraft E, Mitelberg K, Mauda E, Ben-Ami M, Mazor-Aronovitch K, Levy-Shraga Y, Levran N, Levek N, Zimlichman E, Pinhas-Hamiel O. Virtual reality's impact on children with type 1 diabetes: a proof-of-concept randomized cross-over trial on anxiety, pain, adherence, and glycemic control. Acta Diabetol. 2024 Feb;61(2):215-224. doi: 10.1007/s00592-023-02195-9. Epub 2023 Oct 16.

  PMID: 37845502 DERIVED

Study Officials

• Noah Gruber, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 31, 2023
• Study Start: May 10, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: June 25, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)