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Acceptability & Impact of a Diabetes Management Smartphone App (mySugr) for Spanish-literate Adults With Type 2 Diabetes

NCT05975242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-12-05

No results posted yet for this study

Summary

The goal of this clinical trial is to compare those using a diabetes management smartphone application (mySugr) to those not using the application. This smartphone application is for Spanish-literate adults with poorly controlled, non-intensively treated type 2 diabetes (T2D).

The main question\[s\] that it aims to answer are:

* What is the impact of the use of mySugr (a smartphone-based application or app) with structured blood glucose monitoring on diabetes self-management among Hispanic/Latino adults with poorly controlled, non-intensively treated T2D?
* Will diabetes self-management be more effective for those using mySugr (the Active group) compared to those not using mySugr (the Control group) over a 12-week study period? Participants will be screened and enrolled if they are eligible; they will have the study explained to them in Spanish or English and have time to ask questions and then sign an informed consent form. Clinical measurements (including height, weight, and blood pressure) and hemoglobin A1c will be done. All subjects will be given a blood glucose meter, lancing device, and blood glucose strips for the meter, and they will also receive an electronic scale. Several questionnaires will be answered.

If a subject is randomly assigned to the Active group, they will download the mySugr PRO (professional) app in Spanish to their smartphone and be trained in its use. They will receive education focused on paired (before and 2 hours after a meal) blood glucose testing, which participants will conduct twice a day for 6 days and once a month for 3 months. Participants will continue structured blood glucose testing with the mySugr PRO app for 12 weeks, and they will have 3 virtual visits in Spanish with mySugr PRO coaches who will review the blood glucose records and advise the subjects.

Subjects in the Control group will not receive the mySugr PRO app or coaching. They will continue with their usual diabetes management.

All subjects will return after 12 weeks to return the scale and have a close-out visit with clinical measurements and questionnaires. Subjects will also receive a disturbance allowance for their time and participation.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Smartphone diabetes management application

The intervention is a smartphone diabetes management application that is combined with structured blood glucose testing.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Sansum Diabetes Research Institute

    lead OTHER

Principal Investigators

  • Ashley Thorsell, MD · Sansum Diabetes Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2024-04-01
Completion
2024-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975242 on ClinicalTrials.gov