Diabetes
Conditions
Keywords
Glucose Control, Type 2 Diabetes, Continuous Glucose Monitoring, Educational support
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.
Interventions
OTHERContinuous Glucose Monitoring and Education Support
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.
Sponsors
Hackensack Meridian Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A1c - Marker of overall glucose control | At 3 months post enrollment | A1c levels measured at 12 weeks post enrollment will be compared to the baseline A1c level (measured at enrollment). |
| Glycemic control | At 3 months post enrollment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | At 3 months post enrollment | 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. |
| ER visit | For the 3 months post enrollment | To determine if CGM and diabetes education glycemic control as demonstrated by ER visit due to hypoglycemia or hyperglycemic events. |
| Hospital admissions | For the 3 months post enrollment | To determine if CGM and diabetes education glycemic control as demonstrated by hospital admission due to hypoglycemia or hyperglycemic events. |
| Glycemic control - Episodes of hypoglycemia | For the 3 months post enrollment | 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. |
| Blood pressure | At 3 months post enrollment | 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. |
| Diabetes self-care | At 3 months post enrollment | 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). |
| Diabetes distress | At 3 months post enrollment | 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. |
| Satisfaction with CGM device | At 3 months post enrollment | 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. |
| Diabetes knowledge | At 3 months post enrollment | 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. |
| Weight | At 3 months post enrollment | 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. |
Countries
United States
Outcome results
None listed