ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02600845|
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: ACCU-CHEK||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ACCU-CHEK Connect Personal Diabetes Management Study (PDM)|
|Actual Study Start Date :||December 30, 2015|
|Actual Primary Completion Date :||September 29, 2016|
|Actual Study Completion Date :||February 20, 2017|
All participants will utilize ACCU-CHEK Connect Diabetes Management System containing three primary components: ACCU-CHEK Aviva Connect Blood Glucose Monitoring System intended to be used for the quantitative measurement of glucose, ACCU-CHEK Connect Diabetes Management App indicated as an aid in the treatment of diabetes, and ACCU-CHEK Connect Online Diabetes Management System indicated for use by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
ACCU-CHEK Connect Diabetes Management System contains ACCU-CHEK Aviva Connect Blood Glucose Monitoring System, ACCU-CHEK Connect Diabetes Management App, and ACCU-CHEK Connect Online Diabetes Management System.
- Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24 [ Time Frame: Week 24 ]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.
- Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score [ Time Frame: Baseline, Week 24 ]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.
- Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]Assessment of HbA1c is an indicator of long-term control of diabetes.
- Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range [ Time Frame: Baseline, Week 24 ]Glucose target range was specified as 70-180 milligrams per deciliter (mg/dL).
- Change From Baseline to Week 24 in Mean Blood Glucose Level [ Time Frame: Baseline, Week 24 ]Blood glucose is a type of sugar in blood and is measured to assess a participant's control of diabetes.
- Change From Baseline to Week 24 in Glycemic Variability [ Time Frame: Baseline, Week 24 ]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.
- Incidence of Hypoglycemia [ Time Frame: Baseline, Weeks 12 and 24 ]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.
- Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24 [ Time Frame: Week 24 ]Competency was defined as appropriate response to high and low glucose values.
- Percent of Follow-Up Visits With Sufficient SMBG Data [ Time Frame: Up to Week 24 ]Sufficient SMBG data is based on the ability of the healthcare provider to make informed decisions regarding therapy adjustments.
- Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]An increase in the number of blood glucose checks indicates more glycemic control.
- Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 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.
- Percentage of Blood Glucose Tagged Data [ Time Frame: Weeks 12 and 24 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600845
|United States, Alabama|
|Montgomery, Alabama, United States, 36105|
|United States, California|
|Huntington Beach, California, United States, 92648|
|United States, Georgia|
|Atlanta, Georgia, United States, 30318|
|Macon, Georgia, United States, 31210|
|United States, Mississippi|
|Ocean Springs, Mississippi, United States, 39564|
|United States, Nebraska|
|Lincoln, Nebraska, United States, 68521|
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27609|
|Wilmington, North Carolina, United States, 28401|
|United States, Pennsylvania|
|Pottstown, Pennsylvania, United States, 19464|
|United States, Tennessee|
|Bristol, Tennessee, United States, 37620|
|United States, Texas|
|Plano, Texas, United States, 75075|
|Study Director:||Lena Borsa||Hoffmann-La Roche|