治験レーダー

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

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