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OpenTrials
Completed

NCT Number: NCT05081011

Managing Insulin With a Voice AI

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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Key information

Conditions

Medication Adherence Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voice Assistant Device

Device

Voice AI-enabled smart speaker device delivers daily custom insulin titration instructions.

Primary outcomes

  1. Time to Optimal Insulin Dose

    Time frame: 8 weeks

    Number of days between study start date and goal fasting sugar

  2. Insulin Medication Adherence

    Time frame: 8 weeks

    Percentage of adherence to taking insulin based on logs over 8 weeks

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Percentage of Participants Who Achieved Glycemic Control

    Time frame: 8 weeks

    Proportion (percentage) of participants with fasting sugar within goal at end of trial.

  2. Glycemic Improvement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: MIVA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2021
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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