Continuous Glucose Monitoring and Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Improving Glucose Control and Self-Management in Adults With Type 2 Diabetes From Health Disparate Groups Using Continuous Glucose Monitoring and Education Support

Conditions
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Diabetes

Intervention / Treatment
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* Other: Continuous Glucose Monitoring and Education Support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitoring and Education Support Group<br>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. | Other: Continuous Glucose Monitoring and Education Support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c - Marker of overall glucose control | A1c levels measured at 12 weeks post enrollment will be compared to the baseline A1c level (measured at enrollment). | At 3 months post enrollment | 
| A1c - Marker of overall glucose control | A1c levels measured at 24 weeks post enrollment will be compared to the baseline A1c level (measured at enrollment). | At 6 months post enrollment | 
| Glycemic control | To investigate the effect of the Continuous Glucose Monitoring (CGM) device and educational support on the Glycemic control. Glycemic control will be measured based on the percent time that glucose is on target vs off target. On target is within the normal range of 70-180 mg/dL. Off target includes: <54 mg/dL (critical low glucose); < 70 mg/dL (low glucose); >180 mg/dL (high glucose); and >250 mg/dL (very high). The range at 12 weeks post enrollment will be compared to the baseline data that will be collected after the first 14 days (2 weeks). | At 3 months post enrollment | 
| Glycemic control | To investigate the effect of the Continuous Glucose Monitoring (CGM) device and educational support on the Glycemic control. Glycemic control will be measured based on the percent time that glucose is on target vs off target. On target is within the normal range of 70-180 mg/dL. Off target includes: <54 mg/dL (critical low glucose); < 70 mg/dL (low glucose); >180 mg/dL (high glucose); and >250 mg/dL (very high). The range at 24 weeks post enrollment will be compared to the baseline data that will be collected after the first 14 days (2 weeks). | At 6 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | To determine if CGM and diabetes education affects Blood pressure. Blood pressure will be measured before the CGM/education begins and at the 3 month follow up appointment. | At 3 months post enrollment | 
| Weight | To determine if CGM and diabetes education affects weight. Weight will be measured before the CGM/education begins and at the 3 month follow up appointment. | At 3 months post enrollment | 
| BMI | To determine if CGM and diabetes education affects BMI. BMI will be calculated before the CGM/education begins and at the 3 month follow up appointment. | At 3 months post enrollment | 
| ER visit | To determine if CGM and diabetes education glycemic control as demonstrated by ER visit due to hypoglycemia or hyperglycemic events. | For the 3 months post enrollment | 
| Hospital admissions | To determine if CGM and diabetes education glycemic control as demonstrated by hospital admission due to hypoglycemia or hyperglycemic events. | For the 3 months post enrollment | 
| Glycemic control - Episodes of hypoglycemia | To determine if CGM and diabetes education glycemic control as demonstrated by the number of episodes of hypoglycemia occurred during the 3 months post enrollment. The number of hypoglycemic events will be recorded at baseline (2 weeks) and compared to the data collected at the 12 weeks timepoint. | For the 3 months post enrollment | 
| Diabetes knowledge | To determine if CGM and diabetes education Diabetes knowledge. Diabetes knowledge will be measured before the CGM/education begins (baseline) and at the 3 month follow up appointment. Diabetes knowledge will be measured using a 10-item survey called The SKILLD Knowledge Assessment Scale (Spoken Knowledge in Low Literacy patients with Diabetes (SKILLD)). The scale ranges from 0% to 100% with higher scores demonstrating better knowledge. | At 3 months post enrollment | 
| Diabetes self-care | To determine if CGM and diabetes education affects Diabetes self-care. Diabetes self-care will be measured before the CGM/education begins (baseline) and at the 3 month follow up appointment. Diabetes self-care will be measured using a 11-item survey and reflects on activities for the past 7 days. The survey used is called Summary of Diabetes Self-Care Activities . The survey includes five regimen areas: Diet, Exercise, Blood-Glucose Testing, Foot-Care, and Smoking Status and each area is scored separately based on the number of days an event took place (from 0 for 0 days to 7 for each day). | At 3 months post enrollment | 
| Diabetes distress | To determine if CGM and diabetes education affects Diabetes distress. Diabetes distress will be measured before the CGM/education begins (baseline) and at the 3 month follow up appointment. Diabetes distress will be measured using a survey. The 17-item survey called Diabetes Distress Screening (DDS17) assesses the difficulties living with diabetes as it relates to disease. management, support, emotional burden and access to care. Each item is scored from 1 (No distress) to 6 (distress). The overall score is calculated as the mean of all items and higher the number the higher the distress level reported. | At 3 months post enrollment | 
| Satisfaction with CGM device | Using a satisfaction scale, the satisfaction with the CGM device will be measured at 3 months post enrollment. A 15-item Survey will be used to evaluate treatment burden/satisfaction with using a continuous glucose monitor. The survey contains four subscales (Openness, Emotional Burden, Behavioral Burden, and Worthwhileness) as well as a total score. Each can be obtained by calculating the mean item response score for the groups of items below. Each item is scored between 1 and 5 with 1 being strongly disagree and 5 being strongly agree. Higher scores indicate greater satisfaction. | At 3 months post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose Control, Type 2 Diabetes, Continuous Glucose Monitoring, Educational support