Managing Insulin With a Voice AI

Study Overview
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Brief Summary
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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.

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

Conditions
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Medication Adherence

Intervention / Treatment
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* Device: Voice Assistant Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Voice Assistant Device<br>Subjects have their insulin titrated by a voice assistant device for 8 weeks. | Device: Voice Assistant Device<br>* Voice AI-enabled smart speaker device delivers daily insulin titration instructions.<br>|
| No Intervention: Control<br>Subjects have their insulin titrated via standard of care for 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 days adherent to insulin based on logs | 8 weeks | 
| Attitudes toward Diabetes | Change in Composite Score of Attitudes Toward Diabetes (PAID-5) | Baseline and 8 weeks | 
| Attitudes toward Health Technology | Change in Composite Score of Attitudes Toward Health Technology | Baseline and 8 weeks | 
| Attitudes Toward Medication Adherence | Change in Composite Score of Attitudes Toward Medication Adherence | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control | Percentage of 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 | Day 3 and 8 weeks (assessed at the end of each 3 day period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Voice Assistant, Medication Management, Insulin Management, Smart Speaker, AI, Artificial Intelligence, Autonomous Prescriptions