Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Hemoglobin A1c (HbA1c) |
HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. |
Baseline, Week 26 |
|
Secondary |
Average Fasting Blood Glucose |
Mean fasting blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. The measurement taken before breakfast is used to assess fasting blood glucose. For people without diabetes, fasting blood glucose is typically between 70-100 mg/dL while fasting blood glucose for those with diabetes is in the range of 70-130 mg/dL. |
Week1, Week 12, Week 26 |
|
Secondary |
Average Daily Blood Glucose |
Mean daily blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. Blood glucose levels vary depending on when and what food has been consumed. A blood glucose level taken regardless of timing of meals of greater than 200 mg/dL often indicates diabetes. Blood glucose decreases with improved diabetes management. |
Week1, Week 12, Week 26 |
|
Secondary |
Participants With HbA1c <7.0% and no Hypoglycemia |
Percent of study participants experiencing HbA1c <7.0% and no hypoglycemia will be compared between groups. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. |
Week 26 |
|
Secondary |
Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia |
Percent of study participants reaching A1c < 7% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. |
Week 26 |
|
Secondary |
Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia |
Percent of study participants reaching A1c < 7.5% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. |
Week 26 |
|
Secondary |
Participants With HbA1c >10% Achieving HbA1c <7.5% |
Percent of study participants with baseline HbA1c >10% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. |
Baseline, Week 26 |
|
Secondary |
Participants With HbA1c >10% Achieving HbA1c <8.0% |
Percent of study participants with baseline HbA1c >10% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. |
Baseline, Week 26 |
|
Secondary |
Participants With HbA1c >11% Achieving HbA1c <7.5% |
Percent of study participants with baseline HbA1c >11% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. |
Baseline, Week 26 |
|
Secondary |
Participants With HbA1c >11% Achieving HbA1c <8.0% |
Percent of study participants with baseline HbA1c >11% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. |
Baseline, Week 26 |
|
Secondary |
Participants With HbA1c <7.0% and no Weight Gain |
Percent of study participants reaching A1c < 7% without weight gain will be compared between groups. |
Week 26 |
|
Secondary |
Participants With HbA1c <7.0% and no Hypoglycemia |
Percent of study participants reaching A1c < 7% without hypoglycemia will be compared between groups. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. |
Week 12 |
|
Secondary |
Number of Participants With Documented Symptomatic Hypoglycemic Events |
Documented symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs at any time of the day. Number of participants with documented hypoglycemic events will be compared between study groups. |
Baseline through Week 26 |
|
Secondary |
Asymptomatic Hypoglycemic Events |
Asymptomatic hypoglycemia is defined as no typical symptoms reported by the study participant but detected by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL. Incidence of asymptomatic hypoglycemic events will be compared between study groups. |
Baseline through Week 26 |
|
Secondary |
Number of Participants With Severe Hypoglycemic Events |
Severe hypoglycemia is defined as severe cognitive impairment requiring assistance from another person. Number of participants with severe hypoglycemic events will be compared between study groups. |
Baseline through Week 26 |
|
Secondary |
Nocturnal Symptomatic Hypoglycemic Events |
Nocturnal symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs between midnight and 5:59 am. Incidence of nocturnal symptomatic hypoglycemic events will be compared between study groups. |
Baseline through Week 26 |
|
Secondary |
Nocturnal Asymptomatic Hypoglycemic Events |
Nocturnal asymptomatic hypoglycemia is defined as SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL between midnight and 5:59 am. Incidence of nocturnal asymptomatic hypoglycemic events will be compared between study groups. |
Baseline through Week 26 |
|
Secondary |
Percentage of Time With Interstitial Glucose <70 mg/dL |
Percentage of time with a interstitial glucose level below 70 mg/dL as obtained by CGM will be compared between study groups. |
Baseline through Week 26 |
|
Secondary |
Percentage of Time With Interstitial Glucose <54 mg/dL |
Percentage of time with a interstitial glucose level below <54 mg/dL as obtained by CGM will be compared between study groups. |
Baseline through Week 26 |
|
Secondary |
Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL |
Percentage of time with interstitial glucose in the range of 70-180 mg/dL as measured by CGM will be compared between study groups. |
Baseline through Week 26 |
|
Secondary |
Glycemic Variability |
Glycemic variability will be assessed with continuous glucose monitoring (CGM). It will be calculated using CGM and Standard Deviation. |
Week1, Week 12, Week 26 |
|
Secondary |
Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score |
Treatment satisfaction will be assessed with the DTSQs. The DTSQs contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained by summing responses to yield a total score between 0 to 48. Higher scores indicate higher satisfaction with diabetes treatment. |
Baseline, Week 12 |
|
Secondary |
Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score |
Satisfaction with the study treatment will be assessed with items 1, 4, 5, 6, 7, and 8 the DTSQc. Items are rated on a scale of -3 (much less satisfied compared to prior treatment) to 3 (much more satisfied compared to prior treatment). Total scores for these three items range from -18 to +18 with higher scores indicating greater satisfaction with the study treatment compared to their prior treatment. |
Week 26 |
|
Secondary |
Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score |
Satisfaction with the study treatment will be assessed with the TRIM-D survey. TRIM-D includes 28 items that are scored on a scale from 1 to 5. Total scores are transformed to a scale of 0 to 100 where higher scores indicate increased satisfaction. |
Baseline, Week 12, Week 26 |
|
Secondary |
Number of Emergency Room (ER) Visits |
The number of emergency room visits occurring during the treatment period will be compared between study groups. |
Baseline through Week 26 |
|
Secondary |
Number of Hospital Readmissions |
The number of hospital readmissions occurring during the treatment period will be compared between study groups. |
Baseline through Week 26 |
|
Secondary |
Total Daily Insulin Dose |
The total insulin dose measured in units per day will be compared between study groups. |
Baseline, Week 26 |
|