Subjects are requested to perform self-monitoring of blood glucose (SMBG) 4 times per

Transcription

1 APPENDIX 1 Insulin Titration Algorithm Subjects are requested to perform self-monitoring of blood glucose (SMBG) 4 times per day. All subjects will be contacted weekly to review hypoglycemia and adverse events and to discuss insulin dose adjustment. Insulin glargine dose will be adjusted on a weekly basis by the clinic staff according to the following schedule: Mean Fasting SMBG (mg/dl) Insulin Glargine Adjustment 180 Increase by 8 units Increase by 6 units Increase by 4 units Increase by 2 units No change < 70 Decrease by 10% The 3 most recent fasting SMBG values will be used to determine the mean for the week. If during the week a subject has 2 or more fasting blood glucose values < 70 mg/dl, then the dose of insulin glargine will be decreased by 10% even if subject has a mean FBG 95 mg/dl. Insulin glulisine dose will be adjusted according to the following schedule:

2 Pre-Meal Dose of Insulin Glulisine Pattern of Low Preprandial or Bedtime BG Values Pattern of High Preprandial or Bedtime BG Values 10 units Decrease by 1 unit Increase by 1 unit units Decrease by 2 units Increase by 2 units > 20 units Decrease by 3 units Increase by 3 units A pattern of low BG values is defined as 2 or more preprandial or bedtime values < 70 mg/dl in a specific time period per week. A pattern of high BG is defined as 4 or more preprandial values 100 mg/dl, or 4 or more bedtime values 130 mg/dl, in a specific time period per week. The adjustment of the insulin glulisine dose is applied to the meal prior to the time period during which the pattern of high or low glucose is observed (e.g., if the pre-lunch glucose exhibits a high pattern, then the pre-breakfast dose of glulisine would be increased). If both patterns (high and low) are observed for the same time period during the week, the dose of glulisine should be decreased unless the investigator decides otherwise based on the circumstances surrounding the observed patterns. If a meal is skipped, bolus insulin planned for that meal should not be taken. Subjects will be instructed not to skip meals. Premix insulin (Humalog Mix 75/25 or Novolog Mix 70/30) will be adjusted according to the following schedule: Mean Fasting SMBG (mg/dl) Premix Adjustment Evening Dose > 180 Increase by 8 units Increase by 6 units

3 Increase by 4 units Increase by 2 units No change < 70 Decrease by 10% Mean Pre-Dinner SMBG (mg/dl) Premix Adjustment Morning Dose > 180 Increase by 8 units Increase by 6 units Increase by 4 units Increase by 2 units No change < 70 Decrease by 10% If during the week a subject has 2 or more BG values < 70 mg/dl in a specific time period, the dose of premix insulin corresponding to that time period will be decreased. Missing Blood Glucose Values: If a subject records fewer than the recommended 28 blood glucose readings each week then titration recommendations will be made whenever possible. If the investigator judges that too few values were collected and no recommendation should be made, none will be provided. In this case the investigator will counsel the subject on the importance of glucose measurements.

4 APPENDIX 2 Description of Patient-Reported Outcomes Scales The 71-item Diabetes Treatment Satisfaction module assesses satisfaction with diabetes treatment of any type and includes 13 scales as listed below (number of items in parentheses): Advocacy -- recommending treatment to persons with diabetes including family and friends (2) Burden associated with adherence, diet, exercise, performing daily and social activities and enjoying life (14) Convenience remember taking medication, amount of time required to manage diabetes, required procedures (6) Perceived Efficacy patient s perception of the treatment s effectiveness to control blood sugar (3) Flexibility scheduling and allowing variability in meals and activities (4) General Satisfaction -- pleased with current medication (4) Hassle bother associated with dosing, treatment supplies, carrying supplies, supply disposal, pain and discomfort, worries about hypoglycemia and hyperglycemia (8) Interference with daily routine, meals, recreation, family life, sleep schedules, energy levels, making plans, traveling (11) Pain discomfort (3) Preference desire to search out other regimens, continue on current regimen (2) Side Effects gaining weight, unpleasant feelings, distress with hypoglycemia (5) Social interference with social interactions with family and friends, travel, recreation, work and social roles (9) Overall Satisfaction mean of the 12 treatment satisfaction scales

5 The 12-item Comparative Treatment Preference module provides a direct comparison of preference for either basal-bolus or premix, and covers ease, convenience, flexibility, efficacy, social functioning, and preference. Quality-of-life assessment of psychological, physical and social functioning was evaluated by the following scales (number of items in parentheses): Perceived Health (Global Analogue Scale) overall, physical, emotional, personal life and job or work (5) Functional Health Status functional levels of activities of daily living ranging from strenuous activity to basic activities such as dressing, bathing and eating (12) Diabetes-Specific Interference and General Symptom Interference each assessing interference with work, social events, recreational activities, exercise and physical activities, work effectiveness, enjoying life and feeling your best (7 each) Symptoms and Side-Effects Distress diabetes-specific and general symptoms (prevalence, frequency and distress severity) (53) Mental and Emotional Health subscales of anxiety, depression, and loss of behavioral and emotional control (Domain of Psychological Distress) and life satisfaction, positive well being, and emotional ties (Domain of Psychological Well Being) (24) General Health Perceptions sleep disturbance, vitality and general health status (11) Cognitive Function and Performance cognitive acuity, memory, reasoning, disorientation and detachment and self-rated cognitive performance (21) Sexual Symptom Distress (male and female versions) sexual interest and satisfaction, problems with sexual functioning (5 each) Psychosocial (Itemwise) -- unweighted summative score of the 11 items of General Health Perceptions and 24 items of Mental and Emotional Health

6 Psychosocial (Composite) -- unweighted summative score of the 9 subscales of Mental and Emotional Health and General Health Perceptions (depression, general positive affect, emotional ties, anxiety, loss of behavioral and emotional control, life satisfaction, vitality, health status, and sleep disturbance) Overall Quality of Life Factor Score factor analysis combining the scales of General Health Perceptions, Mental and Emotional Health (Psychological Distress and Psychological Well Being), Perceived Health, Symptom Distress, Cognitive Function and Performance