Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy

The proportion of time within target glucose range (3.9 to 10.0 mmol/L) among adults with type 2 diabetes (T2D) inadequately controlled with non-insulin antihyperglycemic therapy compared to a control group not using an FGM device measured during the blinded continuous glucose monitor (CGM) period during the final last two-weeks of the Phase 1

Mean HbA1c (blood drawn for laboratory testing) at the end of Phase 1

Proportion of participants with HbA1c < 7.0% and with HbA1c > 9.0% at the end of Phase 1

Mean glucose based on blinded CGM recordings at the end of Phase 1

• Tight glycemic range (3.9 to 7.8 mmol/L)
• Hypoglycemia range (3.0 to 3.8 mmol/L)
• Clinically significant (level 2) hypoglycemia range (< 3.0 mmol/L)
• Hyperglycemia (> 10.0 mmol/L)

Standard deviation and % coefficient of variation based on blinded CGM recordings

Based on the blinded CGM recording, including:

• All (hypoglycemic episode occurring at anytime);
• Nocturnal (hypoglycemic episode occurring between 12 am and 6 am); and
• Level 2 hypoglycemic (<3.9 mmol/L)

A hypoglycemic episode that requires assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions as reported by participant

The ARMS-D is an 11-item self-reported measure of adherence that assesses one's ability to take and refill medication under different circumstances, and identifies barriers to medication adherence. The ARMS-D demonstrates good internal consistency, reliability (α=0.86), shows good convergent validity with other adherence to medication scales, and independently predicts HbA1c (β=0.16, p<0.01)

The DDS is a 17-item scale that captures four dimensions of distress: emotional burden, regime distress, interpersonal distress and physician distress. The DDS list potential problem areas that people with diabetes may experience. Respondents are asked to indicate the degree to which each problem may be bothering them in their life on a 6-point Likert Scale from 1 (not a problem) to 6 (a very serious problem). The DDS and its subscales has been shown to have good internal reliability (α > 0.87) and validity.

The GMSS is a 15-item self-reported measure of glucose device satisfaction. The GMSS provides a comprehensive profile of key contributors to device satisfaction. The GMSS has shown good criterion validity against the World Health Organization-5 measure of quality of life and the DDS, and the Self-Monitoring Blood Glucose (SMBG) Obstacles scale (all p < 0.001)

The SCPI is a 23-item scale that includes three subscales: Skills; confidence; and preparedness. Each question contains a 7-point Likert scale response. The SCPI has been demonstrated to have high validity internal consistency and test-retest reliability, with no floor or ceiling effect. Furthermore, SCPI scores are significantly correlated with HbA1c in both type 1 diabetes and T2D populations (p < 0.001)

Change in the mean number of antihyperglycemic therapies from baseline to end of

Change in weight (kg) from baseline to end of Phase 1

Change in waist circumference (cm) from baseline to end of Phase 1

Mean number of diabetes self-management education (DSME) goals set per person

Each DSME goal set during the trial is be graded on a 6-point rating scale. Goal attainment scores range from 1 (goal not attempted) to 6 (exceeded expectation).

Mean number of FGM scans for the intervention group; and mean number of self-monitoring of blood glucose for the control arm

Within group change in the proportion of time spent in targeted glucose range based on FGM metrics from the first 2-week and final 2-week periods of Phase 2

Within group change in the proportion of time spent in hypoglycemia (<3.8 mmol/L) ranged based on FGM metrics from the first 2-week and the final 2-week periods of Phase 2

Within group change in the proportion of time spent in hyperglycemia (>10 mmol/L) range based on FGM metrics from the first 2-weeks and final 2-week periods of Phase 2

Within group change in HbA1c based on blood drawn for laboratory testing from the first 2-week and the final 2-week periods of Phase 2

Within group change in mean glucose based on FGM metrics from the first 2-week and final 2-week periods of Phase 2

Within group change in standard deviation and % coefficient of variation based on FGM metrics from the first 2-week and final 2-week periods of Phase 2

Within group change in the frequency of hypoglycemia based on FGM metrics from the first 2-week and final 2-week periods of Phase 2

Within group change in the frequency of severe hypoglycemia, defined as a hypoglycemic episode that required assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions, based on FGM metrics from the first 2-week and final 2-week periods of Phase 2

Within group change in the Adherence to Refills and Medication-Diabetes (ARMS-D) from the beginning to the end of Phase 2

Within group change in the Diabetes Distress Scale from the beginning to the end of Phase 2.

Within group change in the Glucose Monitoring System Satisfaction Survey from the

Within group change in the Skills, Confidence and Preparedness Index (SCPI) from the beginning to the end of Phase 2.

The effect of DSME goal achievement, independent of glucose monitoring system used, on the change in proportion of time spent in targeted glucose range in the final 2-week CGM period of Phase 1 vs baseline

The effect of DSME goal achievement, independent of glucose monitoring system used, on the frequency of FGM-measured hypoglycemia in the final 2-week CGM period of Phase 1 vs baseline

The effect of DSME goal achievement, independent of glucose monitoring system used, on the association between the daily frequency of FGM scanning/self-monitored blood glucose and TIR.

The optimal frequency of glucose testing for greatest impact on glycemic control (TIR)