Managing Insulin With a Voice AI

Medication Adherence Clinical Trial

— MIVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05081011
• Other study ID #: 58276
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Optimal Insulin Dose	Number of days between study start date and goal fasting sugar	8 weeks
Primary	Insulin Medication Adherence	Percentage of adherence to taking insulin based on logs over 8 weeks	8 weeks
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.	Baseline and 8 weeks
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.	Baseline and 8 weeks
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.	Baseline and 8 weeks
Secondary	Percentage of Participants Who Achieved Glycemic Control	Proportion (percentage) of participants with fasting sugar within goal at end of trial.	8 weeks
Secondary	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)