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

NCT05975242 | Completed

• 1 other identifier: IIS-000011
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hispanic/Latino; smartphone application; self-monitoring blood glucose; Spanish; mySugr PRO

Outcome Measures

Primary Outcomes (1)

• Spanish-language Diabetes Self-Efficacy Scale (DSES-S)

  A scale of 8 Likert-type 10-point items to measure self-efficacy of diabetes self-management

  Visit 1, week 1 and Visit 2, week 12

Secondary Outcomes (4)

• Hemoglobin A1c

  Visit 1, week 1 and Visit 2, week 12

• Problem areas in diabetes (PAID) scale

  Visit 1, week 1 and Visit 2, week 12

• Blood glucose measurements

  Week 1, Week 4, Week 8

• Weight

  Visit 1, week 1 and Visit 2, week 12

Other Outcomes (3)

• Health Information Technology Usability Evaluation Scale (Health-ITUES)

  Visit 1, week 1 and Visit 2, week 12

• Mobile App Rating Scale (MARS)

  Visit 1, week 1 and Visit 2, week 12

• Mobile Device Proficiency Questionnaire (MDPQ)

  Visit 1, week 1 and Visit 2, week 12

Study Arms (2)

Interventional group

EXPERIMENTAL

The interventional group will use the digital self-management smartphone application during the 12-week study period and will have access to 3 coaching sessions. The interventional group will be trained in the use of the app and receive education focused on self-monitoring blood glucose based on paired (before and 2 hours after a meal) blood glucose testing, which participants will conduct twice daily for 6 days once monthly for 3 months.

Behavioral: Smartphone diabetes management application

Control group

NO INTERVENTION

The control group will not have use of the digital self-management smartphone application during the 12-week study period and will not have access to 3 coaching sessions. No structured self-monitoring blood glucose testing will be done.

Interventions

Smartphone diabetes management application BEHAVIORAL

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

Also known as: mySugr

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years of age at enrollment
• Self-reported Hispanic/Latino ethnicity
• Spanish-literate with Spanish as preferred language
• Diagnosis of T2D for at least 6 months
• HbA1c 7.5% - 10%
• mySugr-compatible smartphone
• Any glucose lowering therapy except rapid-acting mealtime insulin
• Residence in Central Coast of California -

You may not qualify if:

• \. Type 1 diabetes 2. Use of rapid-acting mealtime insulin 3. Pregnancy 4. Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ashley Thorsell, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be single site, prospective data collection, with pre- and post-intervention comparison. A total of 30 people with T2D will be randomly allocated (2:1 randomization) to the interventional group (n = 20) that will use the digital self-management application during the 12-week study period or the control group (n = 10) without the app.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 3, 2023
• Study Start: April 4, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

US (1)