Managing Insulin With a Voice AI

NCT05081011 | Completed Results FDA Device

• 1 other identifier: 58276
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence

Keywords

Voice Assistant; Medication Management; Insulin Management; Smart Speaker; AI; Artificial Intelligence; Autonomous Prescriptions

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (2)

• Percentage of Participants Who Achieved Glycemic Control

  8 weeks

• Glycemic Improvement

  Day 3 and 8 weeks (assessed at the end of each 3 day period)

Study Arms (2)

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.

Device: Voice Assistant Device

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.

Device: Voice Assistant Device

Interventions

Voice Assistant Device DEVICE

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

Voice Assistant Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 38039007 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ashwin K Nayak, MD
• Organization: Stanford University

aknayak@stanford.edu

(650) 725-5071

Study Officials

• Kevin Schulman, MD, MBA

  Stanford University

  PRINCIPAL INVESTIGATOR

• Ashwin Nayak, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Sharif Vakili, MD, MS, MBA

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 18, 2021
• Study Start: March 24, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 2, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)