Diabetes Mellitus Self Management EducationNCT06840236
Digital Health Intervention On Awareness Of Vaccination Against Influenza Among Adults With Diabetes
An observational study of Diabetes Mellitus Self Management Education and Diabetes, run by LabStyle Innovations Ltd. at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus Self Management Education, Diabetes
- What is being tested?
- Adapted Flu nudge messages and Previously studied based on RCT
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 8,431 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2022to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Inclusion Criteria: subjects from the United States utilizing a Dario application who reported in the app during registration that they had a diagnosis of type 1 or 2 diabetes and who were active on the platform (logged into the app) during the 12-month period up to Sep 2022.
Exclusion Criteria: subjects that are not using Dario platform
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The goal of this study was to retrospectively evaluate the effectiveness of an adapted digital nudge intervention that was designed previously in an RCT setting to increase influenza vaccination rates for PWD in real world setting. The primary objective was to examine the difference in self-reported influenza vaccination rates in three groups: PWD who received the intervention using a previously published approach (group A), PWD who received an adapted digital intervention (group B) and PWD who received no intervention (group C or control). A secondary aim was to investigate whether the intervention led to differences in awareness and knowledge across study groups and examined the relationship between awareness of influenza risks and vaccination rates.
The data was collected between September 2022 and March 2023 to evaluate the effectiveness of an adapted digital nudge intervention designed to increase influenza vaccination rates among people with diabetes (PWD) in a real-world setting. The intervention builds on a previously conducted randomized controlled trial (RCT). Users were automatically assigned to three groups via the customer engagement platform using a randomization algorithm to assign each selected user to one of the test variations. This ensured that each user had an equal chance of being placed in any of the groups.
The three groups are defined as follows: group A received flu nudge messages as described previously in a randomized clinical trial with one message given each month for six months; 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; group C received no flu nudges (Control). No compensation was offered. The intervention messages included education and recommendations related to the importance of getting flu vaccination in the diabetes population.
- Being tested
- Adapted Flu nudge messages, Previously studied based on RCT
- Keywords
- digital health; diabetes management; influenza vaccination; flu vaccination awareness
- Medical subject headings
- Diabetes Mellitus, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Flu nudge messagesBehavioural
Adapted Flu nudge messages - digital health intervention aimed at improving influenza vaccination rates among adults with diabetes at Dario digital platform approach.
Previously studied based on RCTBehavioural
Previously studied flu nudge messages in RCT
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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" Receives: Behavioral: Previously studied based on RCT | |
| Group C | No Intervention regarding flu vaccination was provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in vaccination rates between the study groups
differences between the groups in users with diabetes self-reported influenza vaccination status
Measured: 6 months
Secondary outcomes (1)
Content related differences between the groups
Differences in awareness and knowledge retention levels between the groups measured by response to the question: "Do you know the risks getting the flu has for someone with diabetes" and differences in recollection of educational content between the groups, measured by a self-reported question: "Do you remember seeing any of these messages?"
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Sep 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Self Management EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8,431 participants (actual)
Sponsor and investigators
- Lead sponsor
- LabStyle Innovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840236
- Sponsor's protocol ID
- 22166-01
- Status last verified
- Apr 2023
- First submitted
- 17 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data used for the analysis were anonymized before extraction for this study.
Publications
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.
PubMed 34535755Fundoiano-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.
PubMed 40209214
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Intervention On Awareness Of Vaccination Against Influenza Among Adults With Diabetes
- ClinicalTrials.gov ID
- NCT06840236
- Acronym / sponsor ID
- 22166-01
- Keywords
- digital health; diabetes management; influenza vaccination; flu vaccination awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,431 participants (actual)
- Lead sponsor
- LabStyle Innovations Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this study was to retrospectively evaluate the effectiveness of an adapted digital nudge intervention that was designed previously in an RCT setting to increase influenza vaccination rates for PWD in real world setting. The primary objective was to examine the difference in self-reported influenza vaccination rates in three groups: PWD who received the intervention using a previously published approach (group A), PWD who received an adapted digital intervention (group B) and PWD who received no intervention (group C or control). A secondary aim was to investigate whether the intervention led to differences in awareness and knowledge across study groups and examined the relationship between awareness of influenza risks and vaccination rates.
The data was collected between September 2022 and March 2023 to evaluate the effectiveness of an adapted digital nudge intervention designed to increase influenza vaccination rates among people with diabetes (PWD) in a real-world setting. The intervention builds on a previously conducted randomized controlled trial (RCT). Users were automatically assigned to three groups via the customer engagement platform using a randomization algorithm to assign each selected user to one of the test variations. This ensured that each user had an equal chance of being placed in any of the groups.
The three groups are defined as follows: group A received flu nudge messages as described previously in a randomized clinical trial with one message given each month for six months; 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; group C received no flu nudges (Control). No compensation was offered. The intervention messages included education and recommendations related to the importance of getting flu vaccination in the diabetes population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group B | – | Behavioral: Adapted Flu nudge messagesGroup 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 |
| Group A | – | Behavioral: Previously studied based on RCTreceived 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" |
| Group C | – | –No Intervention regarding flu vaccination was provided |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Flu nudge messagesAdapted Flu nudge messages - digital health intervention aimed at improving influenza vaccination rates among adults with diabetes at Dario digital platform approach. | Behavioural | Group B |
| Previously studied based on RCTPreviously studied flu nudge messages in RCT | Behavioural | Group A |
Primary outcome
Differences in vaccination rates between the study groups
Time frame: 6 months
differences between the groups in users with diabetes self-reported influenza vaccination status
1 secondary outcome
Content related differences between the groups
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 34535755Lee 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.
- Derived from this study: PubMed 40209214Fundoiano-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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. All data used for the analysis were anonymized before extraction for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Self Management Education and Diabetes, run by LabStyle Innovations Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in vaccination rates between the study groups (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06840236, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.