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Behavioral Intervention
CGM Toolkit Training for Diabetes
N/A
Recruiting
Led By Emily Schmied,, PhD
Research Sponsored by San Diego State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current patient of one of the three participating Innercare Clinics with no plans to discontinue care at Innercare within the next 6 months
Be older than 18 years old
Must not have
Patients with newly diagnosed diabetes mellitus (less than one year), diabetes insipidus, diabetes type 1, or gestational diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up clinic implementation to month 9
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if training healthcare professionals increases the number of continuous glucose monitor prescriptions for Type 2 Diabetes patients in a Hispanic/Latino community health center. They will also study if using a
Who is the study for?
This trial is for healthcare professionals at clinics serving a predominantly Hispanic/Latino population, with the goal of increasing continuous glucose monitor (CGM) prescriptions for patients with Type 2 Diabetes. Patients participating must have Type 2 Diabetes and be attending these clinics.
What is being tested?
The study tests if training healthcare providers on CGM guidelines and insurance eligibility can boost CGM prescription rates. It also examines whether having a CGM affects diabetes control in patients, measured by Hemoglobin A1c levels.
What are the potential side effects?
Since this trial focuses on professional training rather than direct medical interventions, there are no traditional side effects involved. However, patient surveys will assess any barriers or difficulties encountered when using prescribed CGMs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently seeing a doctor at Innercare and plan to continue for at least 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I was diagnosed with diabetes less than a year ago, or I have diabetes insipidus, type 1 diabetes, or gestational diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ clinic implementation to month 9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~clinic implementation to month 9
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CGM prescription rates
Secondary study objectives
Challenges and Facilitators to CGM Uptake in Patients with T2D
Effect of CGM Prescription on HgbA1C
Effect of CGM on Individual Diabetes Distress Among Patients with T2D
+1 moreOther study objectives
HCP/Staff Experiences with Prescribing & Monitoring CGM use in Target Population
Participant Experience with Prescribing, Acquiring and/or Using a CGM.
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: Healthcare Prescribers Exposed to CGM Prescriber Toolkit TrainingExperimental Treatment1 Intervention
Participants in this arm will include qualified healthcare prescribers (MDs, DOs, PAs, NPs, etc.) and staff who treat patients with Type 2 diabetes in primary care settings who will receive in depth training using a study-developed prescriber toolkit. The toolkit covers important information including current clinical practice guidelines, eligibility criteria, provider documentation requirements and scripts for discussing CGM use with their patient population. The impact of the training will be evaluated by examining changes in CGM prescription rates for patients with Type 2 diabetes seen in primary care before and after the training is delivered. Secondarily, Participants will be surveyed pre- and post-training to elicit prescribing knowledge and attitudes towards CGM use.
Group II: Healthcare Prescribers Not Exposed to CGM Prescriber Toolkit TrainingActive Control1 Intervention
Participants in this arm are prescribers (MDs, DOs, PAs, NPs, etc.) and staff who will NOT receive in depth training using a study-developed prescriber toolkit.
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Who is running the clinical trial?
National Institute on Minority Health and Health Disparities (NIMHD)NIH
434 Previous Clinical Trials
1,378,515 Total Patients Enrolled
15 Trials studying Diabetes
15,645 Patients Enrolled for Diabetes
San Diego State UniversityLead Sponsor
169 Previous Clinical Trials
114,556 Total Patients Enrolled
University of California, BerkeleyOTHER
186 Previous Clinical Trials
640,430 Total Patients Enrolled
2 Trials studying Diabetes
2,402 Patients Enrolled for Diabetes
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