| Outcome Measures: |
Primary: Glycemic Control Measured by HbA1c, HbA1c (%), 6-months | Secondary: Pancreatic and Hepatic Triglyceride Content, Liver Triglyceride and Pancreatic Triglyceride, 6-months|Weight, 6-months|Beta-Cell Function, Fasting Glucose as a Measure of Beta-Cell Function, 6-months|Glucagon, Measured during mixed meal challenge test., 6-months|Total Daily Insulin Dose, The 3 days average of the total daily dose of insulin used within 3 consecutive days prior office visit 6 month., 6-months|Number of Daily Injections, The 3 days average of the number of daily injections performed within 3 consecutive days prior office visit 6 month., 6-months|Blood Pressure, 6-months|Lipid Profile, 6-months|Liver Function Blood Test, 6-months|Hypoglycemic Events, Reported as hypoglycemic events per month by patient as any blood glucose \<70 mg/dl or symptoms of hypoglycemia with blood glucose \>70 mg/dl, 6-months|Quality of Life Survey (QoL) - General Health Perception, General health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = excellent; 2 = very good; 3 = good; 4 = fair; 5 = poor., 6-months|Beta-Cell Function, Fasting C-peptide as a Measure of Beta-Cell Function, 6 months|Matsuda Index as a Measure of Beta Cell Function, The Matsuda index is a measure of insulin sensitivity and has no minimum/maximum values. Index values are calculated as 500,000/square root of ((fasting glucose x fasting c-peptide x 333) x (mean 120 min post-meal glucose x mean 120 min post-meal c-peptide x 333)). Higher/lower values = better/worse insulin sensitivity., 6 months|Beta-cell Function, AUC c-peptide, 6 Months|Ratio (AUC C-peptide/AUC Glucose), 6 months|AUC Glucose, 6 months|Quality of Life Survey (QoL) - Current Health Perception, Current health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago., 6 months|Quality of Life Survey (QoL) - Treatment Satisfaction, Quality of Life Survey (QoL) - treatment satisfactionTreatment satisfaction was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied., 6 months|Quality of Life Survey (QoL) - Treatment Impact, Treatment impact was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied., 6 months|Quality of Life Survey (QoL) - Social or Vocational Worry, Social or vocational worry was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0-5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time., 6 months|Quality of Life Survey (QoL) - Hypoglycemia Fear, Hypoglycemia fear was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry., 6 months|Quality of Life Survey (QoL) - Glycemia Control Perception, Glycemia control perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1-7, where 1 - extremely controlled and 7 - not at all controlled., 6 months|Quality of Life Survey (QoL) - Lifestyle Flexibility, Lifestyle flexibility was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice., 6 months|Quality of Life Survey (QoL) - Social Stigma, Social stigma was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree., 6 months|Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment, Satisfaction with insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied., 6 months|Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment, Willingness to continue insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing., 6 months
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