CGM Toolkit Training for Diabetes

Recruiting at 1 trial location

Overseen By Nicole Rivera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Newly diagnosed diabetes, Diabetes insipidus, Type 1 diabetes, Gestational diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

318 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether training healthcare professionals increases prescriptions for continuous glucose monitors (CGMs) for patients with Type 2 Diabetes. The goal is to determine if better access to CGMs can improve diabetes management, particularly in clinics serving Hispanic/Latino communities. Patients with Type 2 Diabetes, diagnosed for over a year and regularly visiting certain clinics, may be suitable for this trial. Participants will share their experiences and any barriers faced when using CGMs. The study aims to enhance diabetes care by understanding the impact of healthcare provider training on CGM prescription rates. As an unphased trial, this study offers a unique opportunity to contribute to improving diabetes care in the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on training healthcare providers to prescribe continuous glucose monitors, so it's unlikely that your current medications would be affected.

What prior data suggests that this training method is safe for healthcare professionals?

A previous study showed that continuous glucose monitors (CGMs) are safe for people with diabetes. These devices, worn on the body, provide real-time updates on blood sugar levels. Research shows that most people tolerate CGMs well. Some might experience mild skin irritation from the device, but serious side effects are rare.

For healthcare providers, learning to use CGMs is safe as it is an educational activity, not a physical one. The goal is to enhance their knowledge and skills. Overall, both CGMs and the training for their use have strong safety records. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CGM Toolkit Training for diabetes because it aims to improve how healthcare providers prescribe continuous glucose monitors (CGMs) for people with Type 2 diabetes. Unlike standard treatments that focus on medication or lifestyle changes, this training enhances prescribers' knowledge and communication skills regarding CGM use. By equipping healthcare providers with updated guidelines and effective communication strategies, the training could increase the adoption of CGMs, which are vital tools for better diabetes management. Ultimately, this could lead to more personalized and effective care for patients, bridging the gap between technology and everyday clinical practice.

What evidence suggests that CGM Toolkit Prescriber Training is effective for increasing CGM prescriptions for Type 2 Diabetes?

Research shows that continuous glucose monitors (CGMs) can greatly help people with Type 2 Diabetes control their blood sugar. Studies have found that using a CGM provides patients with real-time information about their glucose levels, aiding in better diabetes management. In regular healthcare settings, patients using CGMs had better blood sugar control compared to those who did not use them. This improved control helps keep blood sugar within the recommended range more effectively, which is crucial for reducing the risk of diabetes-related health issues. In this trial, the CGM Toolkit Prescriber Training aims to increase the use of these devices among healthcare prescribers, potentially leading to better health outcomes for patients. Participants in one arm of the trial will receive in-depth training using a study-developed prescriber toolkit, while those in the other arm will not receive this training. ^{3 5 6 7 8}

Who Is on the Research Team?

Emily Schmied,, PhD

Principal Investigator

San Diego State University

Shiloh Williams, PhD RN

Principal Investigator

San Diego State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Currently employed at one of the participating Innercare clinics (Brawley, El Centro, Calexico)

Have telephone access

Do not plan to move out of the area within the next 6 months

Exclusion Criteria

Plans to move out of the area in the next 6 months

Personnel without experience providing care to adult patients with T2D in primary care settings

I was diagnosed with diabetes less than a year ago, or I have diabetes insipidus, type 1 diabetes, or gestational diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Toolkit Implementation

Healthcare professionals undergo training on CGM prescription guidelines and receive a toolkit to improve CGM prescription rates.

1 month

1 in-person training session, 1 booster session

Patient Surveys and CGM Prescription Monitoring

Patients with Type 2 Diabetes are recruited for surveys at baseline, 3 months, and 6 months to monitor CGM prescription rates and diabetes management outcomes.

6 months

3 survey sessions

Follow-up

Participants are monitored for changes in A1C values and diabetes distress after receiving CGM prescriptions.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CGM Toolkit Prescriber Training

Trial Overview 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.

How Is the Trial Designed?

Group I: Healthcare Prescribers Exposed to CGM Prescriber Toolkit Training Experimental Treatment 1 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 Training Active Control 1 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.

CGM Toolkit Prescriber Training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Continuous Glucose Monitoring System for:

• Type 1 Diabetes
• Type 2 Diabetes

Approved in European Union as Continuous Glucose Monitoring System for:

• Type 1 Diabetes
• Type 2 Diabetes

Approved in Canada as Continuous Glucose Monitoring System for:

• Type 1 Diabetes
• Type 2 Diabetes

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

Published Research Related to This Trial

The prototype continuous glucose monitoring (CGM) device demonstrated high accuracy, providing clinically accurate results 98.9% of the time during a 12-hour study with 15 participants, including those with diabetes.

The device was well tolerated by participants, causing little to no pain and no adverse events, indicating its safety for use in monitoring glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a prototype minimally invasive intradermal continuous glucose monitor. Weinstock, RS., Bristol, S., Armenia, A., et al.[2021]

Glucose meter evaluations show that while many devices perform well according to standards, there are still significant malfunctions reported, with 10,837 adverse events documented in the FDA's MAUDE database in just the first 7 months of 2018.

Using reliability growth management techniques could help reduce the failure rates of glucose meters by analyzing and addressing the issues highlighted in the MAUDE database.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Glucose Meter Adverse Events by Using Reliability Growth With the FDA MAUDE Database. Krouwer, JS.[2020]

The structured training program 'SPECTRUM' was developed in Germany to improve the effectiveness of continuous glucose monitoring (CGM) systems, ensuring users of all ages can benefit from proper training.

Implementing this training program can enhance the quality of CGM usage, potentially leading to better metabolic control in patients, with plans for translations and further clinical trials to evaluate its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SPECTRUM. Gehr, B., Holder, M., Kulzer, B., et al.[2018]

In a study involving 26 physicians and 15 patients with type 1 diabetes, there was only moderate agreement among physicians on insulin dose adjustments based on continuous glucose monitoring data, indicating variability in clinical decision-making.

The automated insulin adjustment algorithm, Advisor Pro, provided recommendations that were similar in direction and magnitude to those of the physicians, suggesting that automated systems can effectively support insulin dosing decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjusting insulin doses in patients with type 1 diabetes who use insulin pump and continuous glucose monitoring: Variations among countries and physicians. Nimri, R., Dassau, E., Segall, T., et al.[2019]

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

The IDEAL CGM web-based training intervention showed proof of concept for improving adherence to continuous glucose monitors (CGM) among adolescents and young adults with type 1 diabetes, although engagement levels varied significantly among participants.

While the study indicated potential benefits for glycemic control and psychosocial measures, it highlighted the need for revisions to enhance participant engagement and ensure effective training before conducting larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study. Smith, MB., Albanese-O'Neill, A., Yao, Y., et al.[2021]

The new continuous glucose monitoring (CGM) system demonstrated strong accuracy over a 10-day period, with a mean absolute relative difference of 9.6%, indicating reliable glucose readings for users.

With 99.6% of measurements categorized as 'no' or 'slight' risk for discrepancies compared to self-monitored blood glucose values, this CGM system supports its use in diabetes management without the need for adjunctive testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. Hughes, J., Welsh, JB., Bhavaraju, NC., et al.[2019]

The Enlite continuous glucose monitoring (CGM) sensor system is a comfortable and user-friendly device that can significantly aid diabetes educators in teaching children and adolescents about managing their glycemic control.

Improvements in the sensor's design have enhanced comfort during insertion and wear, which may lead to better adherence to using the device and ultimately improve its effectiveness in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with the Enlite sensor in a multicenter pediatric study. Evans, K., Richardson, C., Landry, A., et al.[2022]

The use of a real-time glucose-sensor system significantly improved glucose control in patients with type 1 and type 2 diabetes, leading to reduced HbA1c levels and fewer hypoglycemic episodes.

Despite some technical challenges, particularly in type 2 diabetes patients, the positive outcomes suggest that glucose sensors could be an effective educational tool for managing diabetes, warranting further research in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic education and continuous glucose monitoring in insulin-treated diabetic patients]. Thielen, V., Radermecker, RP., Renard, E., et al.[2011]

In a study involving 34 patients with poorly-controlled type 2 diabetes, treatment guidance based on continuous glucose monitoring (CGM) data did not lead to significant improvements in glycaemic control compared to standard advice based on blood glucose and HbA1c levels.

There was also no notable difference in patient satisfaction regarding diabetes treatment between those receiving CGM-based guidance and those receiving traditional guidance, indicating that CGM data may not enhance treatment outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial. Sato, J., Kanazawa, A., Ikeda, F., et al.[2022]

The educational program for real-time continuous glucose monitoring (CGM) was developed through observational research and input from diabetes educators, endocrinologists, and patients, ensuring it meets the needs of those managing diabetes with medications or insulin pumps.

The program emphasizes a structured approach, starting with a group class that educates patients about CGM technology, which helps them make informed decisions about their readiness to use CGM and sets realistic expectations for its benefits and limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring technology for personal use: an educational program that educates and supports the patient. Evert, A., Trence, D., Catton, S., et al.[2018]

A 2-week hands-on continuous glucose monitoring (CGM) module significantly improved knowledge and confidence in CGM use among third-year pharmacy students and practicing pharmacists, with 36 students and 5 pharmacists participating in the study.

While students maintained their confidence in CGM tasks long-term, their knowledge showed a slight decline, indicating the need for ongoing education to reinforce learning about CGM technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and development of a continuous glucose monitoring educational module for students and practicing pharmacists. Sherrill, CH., Lee, S., Bradley, CL.[2022]

Continuous glucose monitoring (CGM) technology has become a standard treatment for type 1 diabetes since the early 2000s, but its integration into clinical practice remains limited.

Recent clinical trials have shown that CGM provides significant benefits for individuals with type 1 diabetes, highlighting the need for systematic training for both patients and healthcare providers to maximize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Clinical Utility of Continuous Glucose Monitoring in Type 1 Diabetes. Haviland, N., Walsh, J., Roberts, R., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6712232/

Continuous Glucose Monitoring Sensors for Diabetes ... CGM sensors deliver an almost continuous glucose trace providing BG readings every 1 to 5 minutes, mitigating the need of SMBG and greatly increasing the ...

2. diabetesjournals.org diabetesjournals.org/clinical/article/43/1/139/157329/Continuous-Glucose-Monitoring-in-Individuals-With

Continuous Glucose Monitoring in Individuals With Type 2 ... The use of CGM in the population of people with type 2 diabetes has been shown to improve patients' ability to use real-time glycemic ...

3. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) What is a CGM? CGMs continually monitor your blood glucose (blood sugar), giving you real-time updates through a device that is attached to your body.

4. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-playbook-directory

CGM Playbook Our CGM Playbook is a practical tool for diabetes care and education specialists, providing a step-by-step pathway to help you and your practice get started.

5. nature.com nature.com/articles/s41598-024-83548-4

Continuous glucose monitoring among adults with type 2 ... CGM use in a primary care setting compared to usual care significantly improved glycemic control in T2D patients not on bolus insulin.

6. pro.aace.com pro.aace.com/cgm/toolkit/integrating-cgm-clinical-practice

aace guide to continuous glucose monitoring (cgm) Here's a step-by-step guide to getting started with CGM devices in your practice. What are the indications for CGM in persons with diabetes mellitus? GUIDELINE: ...

7. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-selection-training

CGM Selection & Training Here's a list of training needs broken into basic and advanced categories that will help you teach a person with diabetes to properly use their CGM.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7755046/

Using Continuous Glucose Monitoring in Clinical Practice This article will provide an overview of CGM and equip health care providers to begin integrating this technology into their clinical practice.