CGM Toolkit Training for Diabetes
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: San Diego State University
Disqualifiers: Newly diagnosed diabetes, Diabetes insipidus, Type 1 diabetes, Gestational diabetes, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
16789How 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.
110111213Eligibility 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
+6 more
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.
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Innercare IncEl Centro, CA
Innercare, IncEl Centro, CA
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Who Is Running the Clinical Trial?
San Diego State UniversityLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
University of California, BerkeleyCollaborator
References
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]Proper training and follow-up for patients new to continuous glucose monitor (CGM) use are required to maintain adherence and achieve diabetes-related outcomes. However, CGM training is hampered by the lack of evidence-based standards and poor reimbursement. We hypothesized that web-based CGM training and education would be effective and could be provided with minimal burden to the health care team.
Adjusting insulin doses in patients with type 1 diabetes who use insulin pump and continuous glucose monitoring: Variations among countries and physicians. [2019]To evaluate physicians' adjustments of insulin pump settings based on continuous glucose monitoring (CGM) for patients with type 1 diabetes and to compare these to automated insulin dose adjustments.
Update on Clinical Utility of Continuous Glucose Monitoring in Type 1 Diabetes. [2022]Since the early 2000s, continuous glucose monitoring (CGM) technology has advanced to become a standard of care in the treatment of type 1 diabetes. Unfortunately, CGM use is not commonly integrated into practice. This article will review the history, technology, and need for systematic training in CGM. Additionally, it will review recent clinical trial data demonstrating the benefits that CGM offers to all people with type 1 diabetes and the clinicians who care for them.
[Therapeutic education and continuous glucose monitoring in insulin-treated diabetic patients]. [2011]The effectiveness of a specific educational programme involving the use of a real-time glucose-sensor system to improve glucose control was investigated in patients with type 1 diabetes (glucose sensor combined with a portable insulin pump--Paradigm Real Time) and in patients with type 2 diabetes poorly controlled despite insulin therapy (Guardian RT one week per month for 3 months compared to blood glucose self-monitoring). Both studies showed a reduction in glycated haemoglobin (HbA1c) levels with the glucose sensor, associated with less symptomatic hypoglycaemic episodes. Despite some technical difficulties (mainly in patients with type 2 diabetes), this approach represents a useful tool for therapeutic education. These promising results justify the initiation of larger studies evaluating glucose sensor use in well selected diabetic patients.
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]To assess the effect of treatment guidance based on data from a continuous glucose monitoring (CGM) device on glycaemic control, and patient satisfaction, in patients with type 2 diabetes mellitus (T2DM).
Pilot study of a prototype minimally invasive intradermal continuous glucose monitor. [2021]The purpose of this study was to assess point accuracy, rate-of-change accuracy, and safety of a prototype, minimally invasive continuous glucose monitoring (CGM) device over a 12 h in-clinic study. The CGM system consisted of a wireless electronics module with a disposable glucose sensor attached to the bottom. The electronics module was affixed to the abdomen using an adhesive pad on the bottom of the disposable sensor housing.
Reducing Glucose Meter Adverse Events by Using Reliability Growth With the FDA MAUDE Database. [2020]Glucose meter evaluations are common and provide important information about glucose meter performance versus standards. Although some meters meet guidelines and others fall short in these evaluations, most results are within the A and B zones of a glucose meter error grid. Another data source that is seldom used is the FDA adverse event database (MAUDE). This database describes glucose meter malfunctions and injury as reported by actual users and returned 10 837 adverse events across all meters for the first 7 months of 2018. Reliability growth management is an established tool to reduce failure rates. A reliability growth example is presented followed by a discussion of how this tool could be applied to reduce glucose meter failure events using the MAUDE database.
Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]Adverse events for continuous glucose monitors (CGMs) represent a significant issue for people with diabetes with 281 963 CGM adverse events occurring in 2022. The process to obtain adverse events and the US Food and Drug Administration (FDA) database that contains them are reviewed.
Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. [2019]Users of continuous glucose monitoring (CGM) systems are concerned with the frequency of inserting and calibrating new sensors, with sensor accuracy and reliability throughout the sensor's functional life, and with the risks associated with inaccurate sensor readings.
Experience with the Enlite sensor in a multicenter pediatric study. [2022]The purpose of this article is to outline the experience of certified diabetes educators (CDEs) using the Enlite continuous glucose monitoring sensor system in a pediatric multicenter randomized controlled trial. Continuous glucose monitoring (CGM) is becoming popular as a tool for educators and families to improve glycemic control. CGM can be a valuable educational tool to demonstrate to the user the impact of insulin dosing and effects of physical activity, food intake, and other life events such as work, illness, and stress on their glycemic control. The authors will share education tips and practical applications for diabetes educators to facilitate education and sustained use of Enlite glucose sensors in children and adolescents using insulin pump therapy.
SPECTRUM. [2018]Optimal usage of continuous glucose monitoring (CGM) requires adequate training of the users. Providing patients with a CGM system without such a training usually doesn't lead to the intended improvement in metabolic control.
Continuous glucose monitoring technology for personal use: an educational program that educates and supports the patient. [2018]The purpose of this article is to describe the development and implementation of an educational program for the initiation of real-time continuous glucose monitoring (CGM) technology for personal use, not 3-day CGMS diagnostic studies. The education program was designed to meet the needs of patients managing their diabetes with either diabetes medications or insulin pump therapy in an outpatient diabetes education center using a team-based approach.
Design and development of a continuous glucose monitoring educational module for students and practicing pharmacists. [2022]This study aimed to investigate a 2-week, hands-on continuous glucose monitoring (CGM) module on third-year pharmacy students' and practicing pharmacists' knowledge and confidence.