NCT07734259

Brief Summary

This is a pre-post pilot study that will test the feasibility and acceptability of a health educator delivered diabetes education and skills training intervention using a voice-activated, touch screen controlled, smart speaker. We will enroll 30 adults aged 50 and older with poorly controlled type 2 diabetes as defined by a hemoglobin A1C of 8% in the study.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
19mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • HemoglobinA1C

    About 10cc of blood will be drawn by phlebotomist and sent to the lab for testing

    Baseline and 3-months post enrollment

  • Blood Pressure

    Blood pressure readings will be obtained using automated blood pressure monitors (OMRON IntelliSenseTM HEM-907 XL). The device will be programmed to take 3 readings at 2-minute intervals and give an average of the 3 blood pressure readings.

    Baseline and 3-months post-enrollment

  • Low-Density Lipoprotein Cholesterol

    About 10cc of blood will be drawn by phlebotomist and sent to the lab for testing

    Baseline and 3-months post-enrollment

Secondary Outcomes (3)

  • Depression

    Baseline and 3-months post-enrollment

  • Social Isolation

    Baseline and 3-months post-enrollment

  • Loneliness

    Baseline and 3-months post-enrollment

Study Arms (1)

VATC-SS Intervention

EXPERIMENTAL

Individuals in the VATC-SS intervention will receive weekly diabetes education and skills training calls for 12 weeks from a health educator through the voice-activated, touch screen controlled smart speaker.

Behavioral: VATC-SS Intervention

Interventions

Individuals in the VATC-SS intervention will receive weekly diabetes education and skills training calls for 12 weeks from a health educator through the voice-activated, touch screen controlled smart speaker.

VATC-SS Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Aged 50 and older; 2) clinical diagnosis of poorly controlled type 2 diabetes, defined as HbA1C greater than or equal to 8% at the screening visit; 3) willing to install and use the VATC-SS for the 3 months of the study.

You may not qualify if:

  • \) Mental confusion at screening assessment suggesting significant dementia; 2) alcohol or drug abuse/dependency at screening assessment; 3) active psychosis or acute mental disorder at screening assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Aprill Z Dawson, PhD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 29, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

March 30, 2028

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share