Behavioral Intervention

Interventional group for Type 2 Diabetes

Sansum Diabetes Research Institute, Santa Barbara, CA
Smartphone diabetes management applicationN/ARecruitingLed by Ashley Thorsell, MDResearch Sponsored by Sansum Diabetes Research Institute

Study Summary

This trial will compare use of a diabetes management smartphone app (mySugr) vs. no use to see if it improves diabetes self-management among Hispanic/Latino adults with type 2 diabetes.

Eligible Conditions
  • Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have a smartphone that is compatible with the mySugr app.
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You have been diagnosed with type 2 diabetes for at least 6 months.
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You are not allowed to take any medication or treatment for lowering blood sugar levels, except for rapid-acting mealtime insulin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1, week 1 and visit 2, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1, week 1 and visit 2, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Spanish-language Diabetes Self-Efficacy Scale (DSES-S)
Secondary outcome measures
Blood glucose measurements
Hemoglobin A1c
Problem areas in diabetes (PAID) scale
+1 more
Other outcome measures
Health Information Technology Usability Evaluation Scale (Health-ITUES)
Mobile App Rating Scale (MARS)
Mobile Device Proficiency Questionnaire (MDPQ)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional groupExperimental Treatment1 Intervention
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.
Group II: Control groupActive Control1 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.

Find a site

Who is running the clinical trial?

Sansum Diabetes Research InstituteLead Sponsor
37 Previous Clinical Trials
2,374 Total Patients Enrolled
Roche Pharma AGIndustry Sponsor
402 Previous Clinical Trials
370,424 Total Patients Enrolled
Ashley Thorsell, MDPrincipal Investigator
Sansum Diabetes Research Institute
1 Previous Clinical Trials
750 Total Patients Enrolled

Media Library

Smartphone diabetes management application (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05975242 — N/A
Type 2 Diabetes Research Study Groups: Interventional group, Control group
Type 2 Diabetes Clinical Trial 2023: Smartphone diabetes management application Highlights & Side Effects. Trial Name: NCT05975242 — N/A
Smartphone diabetes management application (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975242 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this trial populated with participants?

"Affirmative. Clinicaltrials.gov corroborates that this clinical trial, which was first disseminated on April 4th 2023, is actively seeking participants. Approximately 30 individuals need to be enrolled from 1 research site."

Answered by AI

Is this experiment accessible to participants currently?

"Clinicaltrials.gov data indicates that this trial is currently searching for participants, with the first posting of the study occurring on April 4th 2023 and its most recent update being made on July 27th 2023."

Answered by AI
~14 spots leftby Apr 2024