Medication AdherenceMIVANCT05081011

Managing Insulin With a Voice AI

A study testing Voice Assistant Device in people with Medication Adherence, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Medication Adherence
What is being tested?: Voice Assistant Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 24 Mar 2021to 1 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients with Type 2 Diabetes
Patients clinically indicated to be taking daily long-acting insulin
Patients currently taking long-acting insulin but necessitating active dose adjustments

Who cannot join

Patients who do not speak English
Patients who do not own a smart phone
Patients who do not have stable wireless internet connection at home

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: Using an AI-based Voice Assistant to Manage Insulin in Diabetes: a Randomized-Control Trial

This study randomizes participants to have their basal insulin titrated either through standard of care or by receiving prompts through interactions with an AI-enabled smart speaker device. The primary objective of this study is to investigate the feasibility of an AI-enabled smart speaker device and whether such a device facilitates insulin titration management, increases insulin adherence and decreases time to optimal insulin dose. The secondary objective of the study is to explore whether the device improves glycemic control as defined by improvements in fasting blood sugar.

Conditions: Medication Adherence
Being tested: Voice Assistant Device
Keywords: Voice Assistant, Medication Management, Insulin Management, Smart Speaker, AI, Artificial Intelligence, Autonomous Prescriptions
Medical subject headings: Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Voice Assistant DeviceDevice
Voice AI-enabled smart speaker device delivers daily custom insulin titration instructions.
Voice Assistant DeviceDevice
Voice AI-enabled smart speaker device delivers daily generic insulin reminders.

Study groups in NCT05081011
Study group	Role	What they receive
Voice Assistant Device	Experimental	Subjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions. Receives: Device: Voice Assistant Device
Control	Active comparator	Subjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication. Receives: Device: Voice Assistant Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Optimal Insulin Dose
Number of days between study start date and goal fasting sugar
Measured: 8 weeks
Insulin Medication Adherence
Percentage of adherence to taking insulin based on logs over 8 weeks
Measured: 8 weeks
Attitudes Toward Diabetes
Change in Composite Score of Attitudes Toward Diabetes (PAID-5).
A 5-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores of each item are summed to create an overall score (Minimum value = 0; Maximum value = 20). Higher scores denote higher levels of diabetes related distress.
Measured: Baseline and 8 weeks
Attitudes Toward Health Technology
Change in Composite Score of Attitudes Toward Health Technology. A 2-item self-report questionnaire on a 5 point Likert scale, scored 0 to 4. The scores are summed to create an overall score (Minimum value = 0, Maximum value = 8). Higher scores indicated more favorable attitudes toward health technology.
Measured: Baseline and 8 weeks
Attitudes Toward Medication Adherence
Change in Composite Score of Attitudes Toward Medication Adherence. A 5-item self-report questionnaire on a 5-point Likert scale (0 to 4). The scores are summed to create an overall score (Minimum value = 0, Maximum value = 20). Higher scores indicate more favorable attitudes toward medication adherence.
Measured: Baseline and 8 weeks

Secondary outcomes (2)

Percentage of Participants Who Achieved Glycemic Control
Proportion (percentage) of participants with fasting sugar within goal at end of trial.
Measured: 8 weeks
Glycemic Improvement
Change in 3-day average fasting sugars between first 3 days and last 3 days of study
Measured: Day 3 and 8 weeks (assessed at the end of each 3 day period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 20211 Dec 2022

First posted18 Oct 2021
Study start24 Mar 2021
Primary completion1 Dec 2022
Study completion1 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Medication AdherenceStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05081011
Sponsor's protocol ID: 58276
Acronym: MIVA
Status last verified: Dec 2023
First submitted: 5 Oct 2021
Last updated: 2 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Nayak A, Vakili S, Nayak K, Nikolov M, Chiu M, Sosseinheimer P, Talamantes S, Testa S, Palanisamy S, Giri V, Schulman K. Use of Voice-Based Conversational Artificial Intelligence for Basal Insulin Prescription Management Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2340232. doi: 10.1001/jamanetworkopen.2023.40232.
PubMed 38039007

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Medication Adherence trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using an AI-based Voice Assistant to Manage Insulin in Diabetes: a Randomized-Control Trial
ClinicalTrials.gov ID: NCT05081011
Acronym / sponsor ID: MIVA / 58276
Conditions: Medication Adherence
Keywords: Voice Assistant, Medication Management, Insulin Management, Smart Speaker, AI, Artificial Intelligence, Autonomous Prescriptions
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 24 Mar 2021 (actual)
Primary completion: 1 Dec 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 18 Oct 2021 (actual)
Results: Posted 2 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Voice Assistant Device	Experimental	Device: Voice Assistant DeviceSubjects have their insulin titrated by a voice assistant device for 8 weeks. The Voice Assistant Device software algorithm is used to provide daily insulin dose and titration instructions.
Control	Active comparator	Device: Voice Assistant DeviceSubjects have their insulin titrated via standard of care for 8 weeks. The Voice Assistant Device is limited to providing a daily reminder to take medication.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with Type 2 Diabetes
Patients clinically indicated to be taking daily long-acting insulin
Patients currently taking long-acting insulin but necessitating active dose adjustments

Key exclusion criteria (3 listed)

Patients who do not speak English
Patients who do not own a smart phone
Patients who do not have stable wireless internet connection at home

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
Voice Assistant DeviceVoice AI-enabled smart speaker device delivers daily custom insulin titration instructions.	Device	Voice Assistant Device
Voice Assistant DeviceVoice AI-enabled smart speaker device delivers daily generic insulin reminders.	Device	Control

Primary outcome

Time to Optimal Insulin Dose
Time frame: 8 weeks
Number of days between study start date and goal fasting sugar
Insulin Medication Adherence
Time frame: 8 weeks
Percentage of adherence to taking insulin based on logs over 8 weeks
Attitudes Toward Diabetes
Time frame: Baseline and 8 weeks
Change in Composite Score of Attitudes Toward Diabetes (PAID-5). A 5-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores of each item are summed to create an overall score (Minimum value = 0; Maximum value = 20). Higher scores denote higher levels of diabetes related distress.
Attitudes Toward Health Technology
Time frame: Baseline and 8 weeks
Change in Composite Score of Attitudes Toward Health Technology. A 2-item self-report questionnaire on a 5 point Likert scale, scored 0 to 4. The scores are summed to create an overall score (Minimum value = 0, Maximum value = 8). Higher scores indicated more favorable attitudes toward health technology.
Attitudes Toward Medication Adherence
Time frame: Baseline and 8 weeks
Change in Composite Score of Attitudes Toward Medication Adherence. A 5-item self-report questionnaire on a 5-point Likert scale (0 to 4). The scores are summed to create an overall score (Minimum value = 0, Maximum value = 20). Higher scores indicate more favorable attitudes toward medication adherence.

2 secondary outcomes

Percentage of Participants Who Achieved Glycemic Control
Time frame: 8 weeks
Glycemic Improvement
Time frame: Day 3 and 8 weeks (assessed at the end of each 3 day period)

Results and safety

Results posted to the registry on 2 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	18	16
Voice Assistant Device	21	16

Primary outcome: Time to Optimal Insulin Dose

Time frame: 8 weeks. Median (Inter-Quartile Range). Unit: days

Measure	Control n = 16	Voice Assistant Device n = 16
Value	56 (29.5 to 56)	15 (6 to 27)

Control vs Voice Assistant Device: p = 0.006, Log Rank

Population analysed: Participants who received intervention as randomized

Primary outcome: Insulin Medication Adherence

Time frame: 8 weeks. Mean (Standard Deviation). Unit: percentage of adherance

Measure	Control n = 16	Voice Assistant Device n = 16
Value	50.2 (43.0)	82.9 (20.6)

Control vs Voice Assistant Device: Mean Difference (Final Values): 32.7 (95% CI 8.0 to 57.4), p = 0.01, Welch 2-sample method

Population analysed: Participants who received intervention as randomized

Primary outcome: Attitudes Toward Diabetes

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Control n = 16	Voice Assistant Device n = 16
Baseline	6.5 (4.9)	8.4 (3.4)
Change at Week 8	1.7 (4.4)	-1.9 (4.2)

Control vs Voice Assistant Device: Mean Difference (Final Values): -3.6 (95% CI -6.8 to -0.4), p = 0.03, Welch 2-sample method

Population analysed: Participants who received intervention as randomized

Primary outcome: Attitudes Toward Health Technology

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Control n = 16	Voice Assistant Device n = 16
Baseline	6.6 (1.9)	7.1 (1.5)
Change at Week 8	-1.1 (2.3)	0.3 (1.4)

Control vs Voice Assistant Device: Mean Difference (Final Values): 1.4 (95% CI -0.03 to 2.8), p = 0.06, Welch 2-sample method

Population analysed: Participants who received intervention as randomized

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Voice Assistant Device	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38039007Nayak A, Vakili S, Nayak K, Nikolov M, Chiu M, Sosseinheimer P, Talamantes S, Testa S, Palanisamy S, Giri V, Schulman K. Use of Voice-Based Conversational Artificial Intelligence for Basal Insulin Prescription Management Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2340232. doi: 10.1001/jamanetworkopen.2023.40232.
Individual participant dataSharing planned: No

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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.

Kevin Schulman, MD, MBA principal investigator

Stanford University

Ashwin Nayak, MD principal investigator

Stanford University

Sharif Vakili, MD, MS, MBA principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Voice Assistant Device in people with Medication Adherence, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Optimal Insulin Dose (time frame: 8 weeks). The study lists 5 primary outcomes in all. 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 NCT05081011, which also lists 1 linked publication.

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 2 Jan 2024.