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

Trial Summary

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 data supports the effectiveness of the treatment CGM Toolkit Prescriber Training, Continuous Glucose Monitor, Glucose Sensor for diabetes?

Research shows that continuous glucose monitoring (CGM) helps improve blood sugar control in people with diabetes, leading to lower HbA1c levels (a measure of average blood sugar over time) and fewer low blood sugar episodes. Training and education on using CGM can enhance these benefits by improving adherence and understanding of the technology. ^{1 2 3 4 5}

Is the CGM Toolkit Training for Diabetes safe for humans?

Continuous glucose monitors (CGMs) have been associated with a significant number of adverse events, with 281,963 reported in 2022. However, a pilot study of a prototype CGM device assessed its safety over a 12-hour period, indicating ongoing evaluations of safety in these devices. ^{1 6 7 8 9}

How is the CGM Toolkit Prescriber Training treatment different from other diabetes treatments?

The CGM Toolkit Prescriber Training is unique because it focuses on educating patients and healthcare providers on the effective use of continuous glucose monitors (CGMs), which are devices that track blood sugar levels in real-time. Unlike traditional diabetes treatments that may rely solely on medication, this approach emphasizes training and support to improve adherence and outcomes, making it a novel educational intervention in diabetes management. ^{1 10 11 12 13}

What is the purpose of this trial?

Study Overview: This interventional study aims to assess whether training healthcare professionals (HCPs) increases the number of continuous glucose monitor (CGM) prescriptions for patients with Type 2 Diabetes in a Federally Qualified Health Center serving a predominantly Hispanic/Latino population. Research Questions: Does HCP training enhance CGM prescription rates in a primary care setting? Does receiving a CGM prescription lead to improved Type 2 Diabetes control, as measured by Hemoglobin A1c levels? What barriers do patients face when prescribed and using CGMs? Given the significant impact of CGMs on diabetes management, this project seeks to improve CGM utilization among eligible patients through a focused intervention for HCPs and evaluate diabetes outcomes for those who do and do not receive a CGM. Methodology: HCPs and staff from three clinics within the same healthcare system will undergo a brief, in-person training on current clinical guidelines and insurance eligibility for CGMs. A booster session will follow about one month later to reinforce learning and address any prescribing challenges. Training efficacy will be evaluated by comparing CGM prescription rates before and after training using electronic health records. HCPs will complete pre- and post-training surveys to assess changes in knowledge, beliefs, and prescribing practices related to CGMs. Additionally, a small subset of prescribers will participate in interviews about their experiences with CGM prescriptions four months post-training. Patient Recruitment and Surveys: Patients with Type 2 Diabetes will be recruited for surveys at baseline, and at 3 and 6 months. These surveys will gather information on their diabetes management experience, levels of diabetes distress, and whether CGM discussions occurred with their primary care provider. Participants who received CGM prescriptions will share their experiences and any barriers encountered. A subset will also be invited for interviews to further explore their CGM experiences. Conclusion: This study seeks to fill a crucial gap in understanding how HCP training influences CGM prescription rates and the associated diabetes management outcomes, ultimately aiming to enhance diabetes care for a vulnerable population.

Research Team

Emily Schmied,, PhD

Principal Investigator

San Diego State University

Shiloh Williams, PhD RN

Principal Investigator

San Diego State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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 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]

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]

References

1. Canada 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. [2021]

2. England 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Update on Clinical Utility of Continuous Glucose Monitoring in Type 1 Diabetes. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Therapeutic education and continuous glucose monitoring in insulin-treated diabetic patients]. [2011]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pilot study of a prototype minimally invasive intradermal continuous glucose monitor. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Experience with the Enlite sensor in a multicenter pediatric study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

SPECTRUM. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring technology for personal use: an educational program that educates and supports the patient. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Design and development of a continuous glucose monitoring educational module for students and practicing pharmacists. [2022]