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Behavioral Intervention
Diabetes Management App for Type 2 Diabetes (mySugr Trial)
N/A
Recruiting
Led By Ashley Thorsell, MD
Research Sponsored by Sansum Diabetes Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any glucose lowering therapy except rapid-acting mealtime insulin
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1, week 1 and visit 2, week 12
Awards & highlights
mySugr Trial 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.
Who is the study for?
This trial is for Spanish-speaking adults with type 2 diabetes living in Central California who have an HbA1c level between 7.5% and 10%. They must own a smartphone compatible with the mySugr app, not be on rapid-acting insulin, and have no other significant health issues that could affect their participation.Check my eligibility
What is being tested?
The study tests if using the mySugr smartphone app improves diabetes management over a period of 12 weeks compared to usual care without the app. Participants will either use the app along with virtual coaching or continue their regular diabetes treatment without it.See study design
What are the potential side effects?
Since this trial involves using a smartphone application for managing diabetes, there are no direct medical side effects. However, participants may experience frustration or stress from learning new technology or changes in their routine.
mySugr Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on diabetes medication that is not rapid-acting insulin.
mySugr Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 1, week 1 and visit 2, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1, week 1 and visit 2, week 12
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 moreOther outcome measures
Health Information Technology Usability Evaluation Scale (Health-ITUES)
Mobile App Rating Scale (MARS)
Mobile Device Proficiency Questionnaire (MDPQ)
mySugr 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.
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Who is running the clinical trial?
Sansum Diabetes Research InstituteLead Sponsor
38 Previous Clinical Trials
2,248 Total Patients Enrolled
Roche Pharma AGIndustry Sponsor
408 Previous Clinical Trials
400,766 Total Patients Enrolled
Ashley Thorsell, MDPrincipal InvestigatorSansum Diabetes Research Institute
1 Previous Clinical Trials
750 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on diabetes medication that is not rapid-acting insulin.You live in the Central Coast of California.Your HbA1c level is between 7.5% and 10%.I am 18 years old or older.I have been diagnosed with type 2 diabetes for over 6 months.I don't have any health issues that could affect my study participation.You have a smartphone that is compatible with the mySugr app.You identify as Hispanic or Latino.I have Type 1 diabetes.I prefer to communicate in Spanish and can read it well.I use fast-acting insulin before meals.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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