Managing Insulin With a Voice AI

Not Applicable

Completed

• Conditions: Medication Adherence
• Interventions: Device: Voice Assistant Device

• Registration Number: NCT05081011
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-03-24
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-18
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Results First Submitted: 2023-11-20
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Results First Posted: 2024-01-02
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Voice Assistant Device	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.
Voice Assistant Device	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.

Primary Outcome Measures

Name	Time	Method
Time to Optimal Insulin Dose	8 weeks	Number of days between study start date and goal fasting sugar
Insulin Medication Adherence	8 weeks	Percentage of adherence to taking insulin based on logs over 8 weeks
Attitudes Toward Health Technology	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	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.
Attitudes Toward Diabetes	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States