17 Participants Needed

Continuous Glucose Monitors for Uncontrolled Type 2 Diabetes

JA
AC
Overseen ByAnne Camp, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 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, but you must be willing to follow any medication adjustments your provider suggests.

What data supports the effectiveness of the treatment Continuous Glucose Monitor (CGM) for uncontrolled Type 2 Diabetes?

Research shows that real-time continuous glucose monitoring (RT-CGM) helps people with diabetes better manage their blood sugar levels by providing detailed information on glucose patterns, which can motivate behavior changes and improve glucose control.12345

Is continuous glucose monitoring safe for humans?

Continuous glucose monitors (CGMs) are generally considered safe for people with diabetes, though some users report mild discomfort or skin irritation. They are a low-pain method and have been used safely across various age groups, but there are some limitations like sensor accuracy and the need for calibration.678910

How is the Continuous Glucose Monitor (CGM) treatment different from other treatments for uncontrolled Type 2 Diabetes?

The Continuous Glucose Monitor (CGM) treatment is unique because it continuously tracks glucose levels in real-time, providing immediate feedback and alerts, unlike traditional methods that require manual blood sugar checks. This allows for more precise and timely management of diabetes, helping to improve glucose control and reduce the risk of low blood sugar episodes.211121314

What is the purpose of this trial?

This non-blinded, non-randomized pre-post study will examine the impact of providing CGM sensors free of charge to adult patients of Fair Haven Community Health Care with poorly controlled type 2 diabetes on glycemic control and quality of life.

Research Team

KL

Kasia Lipska, MD MHS

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults with poorly controlled type 2 diabetes who are patients at Fair Haven Community Health Care. It's designed to see if using a Continuous Glucose Monitor (CGM) helps manage their condition better.

Inclusion Criteria

A1c greater than or equal to 8.0 within two weeks of the time of enrollment
I have been on insulin for at least a year, with or without other diabetes medications.
Stated willingness to comply with all study procedures and availability for the duration of the study
See 5 more

Exclusion Criteria

Pregnancy
I have not had diabetic ketoacidosis in the last 6 months.
Contraindications to CGM use
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive CGM sensors and are instructed on their use. Medication adjustments are made based on CGM data.

12 weeks
3 visits (in-person) at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with additional A1c measurements and questionnaire completions.

12 weeks
1 visit (in-person) at 24 weeks

Treatment Details

Interventions

  • Continuous Glucose Monitor (CGM)
Trial Overview The study provides free CGM sensors to participants and observes any changes in blood sugar control and quality of life before and after the use of CGMs, without comparing different groups or treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Poorly Controlled Type 2 Diabetes- CGMExperimental Treatment1 Intervention
Participants will have CGM sensor placed at first visit and will be worn for 12 weeks. Sensor must be scanned 3 times daily. Adjustments to medication regimen will be recommended at 6 weeks. Follow-up appointments will be at 12 weeks and 24 weeks.

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

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Continuous Glucose Monitoring System for:
  • Type 1 diabetes
  • Type 2 diabetes
  • Glycemic control
  • Hypoglycemia prevention
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Continuous Glucose Monitoring System for:
  • Type 1 diabetes
  • Type 2 diabetes
  • Glycemic control
  • Hypoglycemia prevention
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Continuous Glucose Monitoring System for:
  • Type 1 diabetes
  • Type 2 diabetes
  • Glycemic control
  • Hypoglycemia prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Yale Office of Global Health

Collaborator

Trials
1
Recruited
20+

Findings from Research

In a study of 65 patients with poorly controlled type 2 diabetes, those using a real-time continuous glucose monitoring system (RT-CGM) showed a significant reduction in HbA1c levels from 9.1% to 8.0% over 12 weeks, compared to a smaller reduction in the self-monitoring blood glucose (SMBG) group.
The RT-CGM group also experienced improvements in lifestyle factors, including reduced calorie intake, weight loss, lower body mass index (BMI), and increased exercise time, indicating that RT-CGM not only aids in glucose control but also promotes healthier habits.
Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes.Yoo, HJ., An, HG., Park, SY., et al.[2022]
Real-time continuous glucose monitoring (RT-CGM) significantly reduces HbA1c levels in patients with type 1 diabetes compared to self blood glucose measurement (SBGM), based on a systematic review of 7 randomized controlled trials involving 948 participants.
The use of RT-CGM does not increase the risk of major hypoglycemic episodes, and consistent use (over 60-70% of the time) is linked to better glucose control, indicating its safety and efficacy in diabetes management.
Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials.Szypowska, A., Ramotowska, A., Dzygalo, K., et al.[2022]
A program for real-time continuous glucose monitoring (rtCGM) in hospitalized patients with diabetes showed a mean absolute relative difference (MARD) of 10.3% when compared to traditional blood glucose measurements, indicating good accuracy for monitoring glucose levels.
The study found that 99.2% of rtCGM data points were clinically acceptable, suggesting that while rtCGM can effectively alert for hypoglycemia, insulin dosing should still rely on fingerstick measurements to avoid potential discrepancies in treatment.
Practical implementation of remote continuous glucose monitoring in hospitalized patients with diabetes.Baker, M., Musselman, ME., Rogers, R., et al.[2022]

References

Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. [2022]
Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials. [2022]
Practical implementation of remote continuous glucose monitoring in hospitalized patients with diabetes. [2022]
A Prospective Multicenter Clinical Performance Evaluation of the C-CGM System. [2022]
A head-to-head comparison between Guardian Connect and FreeStyle Libre systems and an evaluation of user acceptability of sensors in patients with type 1 diabetes. [2022]
Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]
Open-Source Technology for Real-Time Continuous Glucose Monitoring in the Neonatal Intensive Care Unit: Case Study in a Neonate With Transient Congenital Hyperinsulinism. [2021]
[Metabolic/glycemic control accuracy, effect and complications of the continuous glucose monitoring system in diabetic patients]. [2019]
Real-time continuous glucose monitoring in the clinical setting: the good, the bad, and the practical. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Continuous glucose monitoring: current use and future directions. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Comparative Accuracy Analysis of a Real-time and an Intermittent-Scanning Continuous Glucose Monitoring System. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. [2019]
[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. [2022]
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