Assessing Adherence to Digital Health Technologies Among Hispanic/Latino Adults With or At Risk of Type 2 Diabetes:

NCT04820348 | Completed

• 1 other identifier: IRB-FY2021-54
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

In an effort to personalize medical care, novel approaches have been used to categorize sub-populations of patients with type 2 diabetes (T2D). These are based on biological and genetic variables, allowing identification of clusters with significantly different clinical characteristics and risks of complications that may be more amenable to targeted and precise therapeutic interventions. Increasingly, wearable and other digital health technologies have the potential to capture additional and objective information to support personalized medicine but at present underserved populations have largely been excluded from clinical trials incorporating digital health. With this study, the Investigators aim to build on prior work using specially trained community health workers ("Community Scientists") to support engagement with an underserved population and to encourage adherence to using wearables and other digital health technologies. In the US, this is especially imperative for the Hispanic/Latino population, which is at high risk for T2D and associated complications.

Conditions

Diabetes Mellitus, Type 2; Depression; Anxiety; Diet Habit

Keywords

Diabetes Mellitus, Type 2; Minority Health; Endophenotype

Outcome Measures

Primary Outcomes (1)

• Adherence to wearing continuous glucose monitoring (CGM) devices to measure glucose levels.

  Unit of measure: Percent of time and percent of days CGM is active during the study period.

  2 weeks

Secondary Outcomes (9)

• Adherence to wearing ActiGraph to measure physical activity and sleep.

  2 weeks

• Adherence to wearing Fitbit to measure physical activity and sleep.

  2 weeks

• Adherence to using the HealthSense app to capture food intake data.

  2 weeks

• Adherence to using the MyFitnessPal app to capture food intake data.

  2 weeks

• Feasibility of measuring glycemic impact of meal quantity and composition using CGMs.

  2 weeks

Eligibility Criteria

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

Study Population

Hispanic/Latino adults with or at high risk of developing type 2 diabetes and who currently use a compatible smartphone will be enrolled.

You may qualify if:

• Adults ≥ 18 years of age at Visit 1.
• Self-reported Hispanic/Latino heritage.
• Self-reported diagnosis of type 2 diabetes OR self-reported as at risk for developing type 2 diabetes OR healthy individuals who are not at-risk or have diabetes (healthy controls).
• Based on staff's judgment, the subject must have a good understanding, ability, and willingness to adhere to the protocol and to participate in the video-recording part of the study.
• Exclusive and continuous use, for the 2 week participation period, of a study-compatible smartphone.

You may not qualify if:

• Currently taking insulin as treatment for diabetes.
• Pregnant.
• Any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation in the trial.
• Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of study activities and informed consent.
• Current participation in other trials involving medications or devices.
• Meets criteria for substance use disorders as defined by DSM-5 (e.g., abuse of alcohol, narcotics, or illicit drugs).
• Self-reported diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia or antisocial personality disorder.
• At high risk for suicide based on staff judgement.
• Neuromuscular disease.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• William Marsh Rice University: collaborator
• Carnegie Mellon University: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression; Anxiety Disorders; Feeding Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Behavior, Animal

Study Officials

• David Kerr, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 29, 2021
• Study Start: April 9, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)