60 Participants Needed

Continuous Glucose Monitor for Type 2 Diabetes

RL
Overseen ByRyan Larson, PharmD, CPP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since you need an active prescription for insulin and must inject at least once daily, it seems you will continue using insulin.

What data supports the effectiveness of the treatment Continuous Glucose Monitor for Type 2 Diabetes?

Continuous glucose monitoring (CGM) has been shown to help people with diabetes, including type 2, by providing detailed information about blood sugar patterns, which can lead to better management of their condition. Studies indicate that CGM can improve blood sugar control and reduce the risk of low blood sugar episodes by allowing for timely adjustments in diet and medication.12345

Is continuous glucose monitoring (CGM) safe for humans?

Continuous glucose monitors (CGMs) have been used safely in people with diabetes, including children, for managing blood sugar levels. However, there were 281,963 adverse events reported in 2022, which suggests that while generally safe, there can be issues that users should be aware of.26789

How is the Continuous Glucose Monitor treatment different from other treatments for type 2 diabetes?

The Continuous Glucose Monitor (CGM) is unique because it continuously tracks glucose levels in the body, providing real-time data and alerts for high or low blood sugar, which helps improve glucose control without increasing the risk of hypoglycemia (low blood sugar). Unlike traditional methods that require finger-prick blood tests, CGMs offer a more comprehensive view of glucose patterns, aiding in better diabetes management.15101112

What is the purpose of this trial?

The purpose of this research is to find out if using a continuous glucose monitor and working with a clinical pharmacist can help improve the health of uninsured minority patients with type 2 diabetes.

Research Team

RL

Ryan Larson, PharmD, CPP

Principal Investigator

Myers Park Internal Medicine

Eligibility Criteria

This trial is for uninsured Hispanic or non-Hispanic Black individuals with type 2 diabetes, specifically those who have had an HbA1c level of 8% or higher in the past three months and are currently taking insulin injections at least once a day.

Inclusion Criteria

I am either Hispanic or non-Hispanic Black.
My HbA1c level has been 8% or higher in the last 3 months.
I have been diagnosed with Type 2 diabetes.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a continuous glucose monitor and pharmacist-led medication management services

6 months
At least 1 visit per month (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Continuous Glucose Monitor
Trial Overview The study is testing whether using a continuous glucose monitor (CGM) along with support from a clinical pharmacist can better manage blood sugar levels in participants compared to usual care without these additional tools.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Glucose MonitorExperimental Treatment1 Intervention
Patients in the intervention arm will receive a continuous glucose monitor in addition to usual care. These patients will be scheduled at least once monthly for clinical pharmacy visits.
Group II: Usual CareActive Control1 Intervention
Patients in the usual care arm will have routine physician office visits every 3 months if HbA1c outside goal or every 6 months if HbA1c within goal. Medication regimens will be managed by physicians, nurse practitioners, and physician assistants.

Continuous Glucose Monitor is already approved in United States, European Union, Canada, Japan for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Continuous Glucose Monitor for:
  • Type 1 Diabetes
  • Type 2 Diabetes
  • Insulin-treated Diabetes
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Continuous Glucose Monitor for:
  • Type 1 Diabetes
  • Type 2 Diabetes
  • Gestational Diabetes
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Continuous Glucose Monitor for:
  • Type 1 Diabetes
  • Type 2 Diabetes
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as Continuous Glucose Monitor for:
  • Type 1 Diabetes
  • Type 2 Diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

American Society of Health System

Collaborator

Trials
1
Recruited
60+

Findings from Research

Continuous glucose monitoring (CGM) technology allows for real-time tracking of glucose levels, helping users manage their blood sugar more effectively without increasing the risk of hypoglycemia.
Key challenges for CGM include ensuring sensor accuracy, reliability, and comfort, which are essential for advancing towards artificial pancreas systems that automate blood sugar management.
Continuous glucose monitoring: current use and future directions.DeSalvo, D., Buckingham, B.[2022]
Continuous glucose monitoring (CGM) significantly improves diabetes management for insulin-requiring patients, particularly in type 1 diabetes, by providing real-time insights into glycemic fluctuations and allowing for better lifestyle and medication adjustments.
The review highlights that CGM can lead to improved hemoglobin A1c (A1C) levels, reduced hypoglycemia, and enhanced quality of life, suggesting its potential benefits for broader patient populations with proper education and support.
Continuous glucose monitoring: A review of the technology and clinical use.Klonoff, DC., Ahn, D., Drincic, A.[2022]
Continuous glucose monitors (CGMs) have been developed and are available, but their widespread use in diabetes care is still limited due to insufficient evidence of their effectiveness in improving glycemic control for most type 1 diabetes patients.
Current studies show a lack of controlled trials demonstrating significant impacts of CGMs on important health metrics like hemoglobin A1c and hypoglycemia frequency, highlighting the need for future research to focus on patient outcomes and the overall effectiveness of CGMs.
Continuous glucose monitors: the long-awaited watch dogs?Wentholt, IM., Hoekstra, JB., Devries, JH.[2007]

References

Continuous glucose monitoring: current use and future directions. [2022]
Continuous glucose monitoring: A review of the technology and clinical use. [2022]
Continuous glucose monitors: the long-awaited watch dogs? [2007]
Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. [2022]
Continuous Glucose Monitoring for the Internist. [2022]
Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]
Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor. [2019]
Clinical overview of continuous glucose monitoring. [2021]
Extended use of a new continuous glucose monitoring system with wireless data transmission in children with type 1 diabetes mellitus. [2009]
Usability and Teachability of Continuous Glucose Monitoring Devices in Older Adults and Diabetes Educators: Task Analysis and Ease-of-Use Survey. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]
[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. [2022]
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