Digital Health Intervention On Awareness Of Vaccination Against Influenza Among Adults With Diabetes

NCT06840236 | Completed

• 1 other identifier: 22166-01
• Study Type: observational
• Target: 8,431
• Locations: 1 country
• Sites: 1

Brief Summary

The study leveraged the Dario digital health platform to retrospectively analyze data from 64,904 users with diabetes assigned by the platform into three groups: Group A received previously studied monthly flu nudge messages; Group B received an adapted intervention with 2-3 monthly messages; Group C served as the control with no intervention. Surveys were conducted at baseline, three months, and six months to assess vaccination status, awareness of influenza risks, and recollection of educational content. Statistical analyses, including logistic regression, Chi-square tests, and t-tests, were used to evaluate differences between groups.

Conditions

Diabetes Mellitus Self Management Education; Diabetes

Keywords

digital health; diabetes management; influenza vaccination; flu vaccination awareness

Outcome Measures

Primary Outcomes (1)

• Differences in vaccination rates between the study groups

  differences between the groups in users with diabetes self-reported influenza vaccination status

  6 months

Secondary Outcomes (1)

• Content related differences between the groups

  6 months

Study Arms (3)

Group B

Group B received similar messages that were adapted in frequency with 2-3 messages per month for six months and matched the Dario platform's user experience

Behavioral: Adapted Flu nudge messages

Group A

received flu nudge messages as described previously in a randomized clinical trial: "Lee JL et al. Digital intervention increases influenza vaccination rates for people with diabetes in a decentralized randomized trial. Npj Digit Med 2021 Sep 17;4(1):138. doi: 10.1038/s41746-021-00508-2"

Behavioral: Previously studied based on RCT

Group C

No Intervention regarding flu vaccination was provided

Interventions

Adapted Flu nudge messages BEHAVIORAL

Adapted Flu nudge messages - digital health intervention aimed at improving influenza vaccination rates among adults with diabetes at Dario digital platform approach.

Group B

Previously studied based on RCT BEHAVIORAL

Previously studied flu nudge messages in RCT

Group A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study leveraged the Dario digital health platform to analyze data from 64,904 users with diabetes assigned by the platform into three groups: Group A received previously studied monthly flu nudge messages; Group B received an adapted intervention with 2-3 monthly messages; Group C served as the control with no intervention.

Sponsors & Collaborators

• LabStyle Innovations Ltd.: lead

Study Sites (1)

Labstyle Innovation ltd

Caesarea, 3079821, Israel

Location

Related Publications (2)

• Lee JL, Foschini L, Kumar S, Juusola J, Liska J, Mercer M, Tai C, Buzzetti R, Clement M, Cos X, Ji L, Kanumilli N, Kerr D, Montanya E, Muller-Wieland D, Ostenson CG, Skolnik N, Woo V, Burlet N, Greenberg M, Samson SI. Digital intervention increases influenza vaccination rates for people with diabetes in a decentralized randomized trial. NPJ Digit Med. 2021 Sep 17;4(1):138. doi: 10.1038/s41746-021-00508-2.

  PMID: 34535755 BACKGROUND

• Fundoiano-Hershcovitz Y, Lee F, Stanger C, Breuer Asher I, Horwitz DL, Manejwala O, Liska J, Kerr D. Digital Health Intervention on Awareness of Vaccination Against Influenza Among Adults With Diabetes: Pragmatic Randomized Follow-Up Study. J Med Internet Res. 2025 Apr 10;27:e68936. doi: 10.2196/68936.

  PMID: 40209214 DERIVED

Related Links

• The intervention improved influenza vaccination rates in PWD, suggesting that leveraging new technology to deliver knowledge and information can improve influenza vaccination rates in high-risk populations to reduce public health burden of influenza.

MeSH Terms

Conditions

Diabetes Mellitus; Influenza, Human

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: September 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: February 21, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)