Continuous Glucose Monitoring and Diabetes

Hackensack Meridian Health

Status: Terminated

Conditions: Diabetes

Treatments: Other: Continuous Glucose Monitoring and Education Support

Study type: Interventional

Funder types: Other

Identifiers

NCT05840250

Pro2022-0402

Details and patient eligibility

About

The study is a longitudinal single-arm prospective study design. Adult patients who are African American or Hispanic with type 2 diabetes mellitus will be recruited to participate in this study. The goal of the study is to determine if the use of a continuous glucose monitoring system will improve diabetes management in persons from health disparity background.

The subjects will be closely monitored for the first 3 months as they utilize the continuous glucose monitor and engage in diabetes education classes. They will then be followed for an additional 3 months to determine if they are able to maintain the same glucose control as experienced for the initial 3 months.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subjects with type 2 diabetes mellitus ≥18 years
• African-American or Hispanic
• with A1c ≥8% to ≤12%

Exclusion criteria

• Patients with type 1 diabetes,
• pregnant,
• End-Stage Renal Disease,
• recent use of any CGM within the last 12 months,
• on steroid therapy and history of adhesive allergy.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Continuous Glucose Monitoring and Education Support Group

Experimental group

Description:

Participants will be provided with a device to monitor their blood glucose (Abbott Free Style Libre2 Flash CGM system) along with educational materials to better understand and manage their diabetes and other supporting services. Pre and post intervention surveys will be implemented. Participants will be closely monitored for 3 months and then followed up for 3 more months for a total of 6-month participation.

Treatment:

Other: Continuous Glucose Monitoring and Education Support