| Outcome Measures: |
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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|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|Number of Hospital Readmissions, The number of hospital readmissions occurring during the treatment period will be compared between study groups., Baseline through Week 26|Total Daily Insulin Dose, The total insulin dose measured in units per day will be compared between study groups., Baseline, Week 26
|
