Clinical trial NCT05840250: Continuous Glucose Monitoring and Diabetes
Official title: Improving Glucose Control and Self-Management in Adults With Type 2 Diabetes From Health Disparate Groups Using Continuous Glucose Monitoring and Education Support
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Keywords: Glucose Control
Type 2 Diabetes
Continuous Glucose Monitoring
Educational support
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: A1c - Marker of overall glucose control
timeFrame: At 3 months post enrollment
measure: A1c - Marker of overall glucose control
timeFrame: At 6 months post enrollment
measure: Glycemic control
timeFrame: At 3 months post enrollment
measure: Glycemic control
timeFrame: At 6 months post enrollment
Secondary outcomes:
measure: Blood pressure
timeFrame: At 3 months post enrollment
measure: Weight
timeFrame: At 3 months post enrollment
measure: BMI
timeFrame: At 3 months post enrollment
measure: ER visit
timeFrame: For the 3 months post enrollment
measure: Hospital admissions
timeFrame: For the 3 months post enrollment
measure: Glycemic control - Episodes of hypoglycemia
timeFrame: For the 3 months post enrollment
measure: Diabetes knowledge
timeFrame: At 3 months post enrollment
measure: Diabetes self-care
timeFrame: At 3 months post enrollment
measure: Diabetes distress
timeFrame: At 3 months post enrollment
measure: Satisfaction with CGM device
timeFrame: At 3 months post enrollment
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack Univeristy Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Colette Knight, MD
role: PRINCIPAL_INVESTIGATOR
References:
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