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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voice Assistant Device | Device | Voice AI-enabled smart speaker device delivers daily custom insulin titration instructions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Optimal Insulin Dose | Number of days between study start date and goal fasting sugar | 8 weeks |
| Insulin Medication Adherence | Percentage of adherence to taking insulin based on logs over 8 weeks | 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. | 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. | 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. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Glycemic Control | Proportion (percentage) of participants with fasting sugar within goal at end of trial. | 8 weeks |
| Glycemic Improvement | Change in 3-day average fasting sugars between first 3 days and last 3 days of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Schulman, MD, MBA | Stanford University | Principal Investigator |
| Ashwin Nayak, MD | Stanford University | Principal Investigator |
| Sharif Vakili, MD, MS, MBA | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38039007 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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. |
| FG001 | Voice Assistant Device | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who received intervention as randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | 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. |
| BG001 | Voice Assistant Device |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Optimal Insulin Dose | Number of days between study start date and goal fasting sugar | Participants who received intervention as randomized | Posted | Median | Inter-Quartile Range | days | 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashwin K Nayak, MD | Stanford University | (650) 725-5071 | aknayak@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2022 | Dec 12, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2021 | Dec 12, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Voice Assistant Device | Device | Voice AI-enabled smart speaker device delivers daily generic insulin reminders. |
|
| Day 3 and 8 weeks (assessed at the end of each 3 day period) |
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.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Insulin Medication Adherence | Percentage of adherence to taking insulin based on logs over 8 weeks | Participants who received intervention as randomized | Posted | Mean | Standard Deviation | percentage of adherance | 8 weeks |
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| Primary | 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. | Participants who received intervention as randomized | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
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| Primary | 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. | Participants who received intervention as randomized | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
|
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|
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| Primary | 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. | Participants who received intervention as randomized | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
|
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| Secondary | Percentage of Participants Who Achieved Glycemic Control | Proportion (percentage) of participants with fasting sugar within goal at end of trial. | Participants who received intervention as randomized | Posted | Number | 95% Confidence Interval | percentage of participants | 8 weeks |
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| Secondary | Glycemic Improvement | Change in 3-day average fasting sugars between first 3 days and last 3 days of study | Participants who received intervention as randomized | Posted | Mean | Standard Deviation | mg/dL | Day 3 and 8 weeks (assessed at the end of each 3 day period) |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Voice Assistant Device | 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. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D001519 | Behavior |