ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)

The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3='much worse now' to 3='much better now'). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only.

Time frame: Week 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24.

An increase in SMBG frequency indicates more glycemic control. The average number of daily SMBG measurements per interval was calculated based on the total number of blood glucose readings recorded during the study visit interval.

Time frame: Baseline, Weeks 12 and 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.

An increase in the number of blood glucose checks indicates more glycemic control.

Time frame: Baseline, Weeks 12 and 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.

Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.

Time frame: Baseline, Week 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.

Glycemic variability refers to swings in blood glucose levels. Mean glycemic variability is expressed as a standard deviation of blood glucose data. A negative number indicates a decrease in glucose variability. A positive number indicates and increase in glucose variability.

Time frame: Baseline, Week 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.

Blood glucose is a type of sugar in blood and is measured to assess a participant's control of diabetes.

Time frame: Baseline, Week 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.

A hypoglycemic reading was defined as a glucose value that fell below the 70 mg/dL level. The incidence of hypoglycemia was defined as the number of hypoglycemic readings in the interval divided by the total number of blood glucose checks in the interval.

Time frame: Baseline, Weeks 12 and 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.

Assessment of HbA1c is an indicator of long-term control of diabetes.

Time frame: Baseline, Weeks 12 and 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.

Glucose target range was specified as 70-180 milligrams per deciliter (mg/dL).

Time frame: Baseline, Week 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.

Competency was defined as appropriate response to high and low glucose values.

Time frame: Week 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.

Tagged data specifies the timing of blood glucose recording and includes: fasting, before breakfast, after breakfast, before lunch, after lunch, before dinner, after dinner, and bedtime. The percentage of blood glucose tagged data per interval was calculated as the total number of tagged blood glucose readings during the interval divided by the total number of readings within the interval.

Time frame: Weeks 12 and 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.

Sufficient SMBG data is based on the ability of the healthcare provider to make informed decisions regarding therapy adjustments.

Time frame: Up to Week 24

Population: The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.