Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Roche Diabetes Care | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This post-market, interventional, prospective, single arm, the United States (US) based multi-center study will assess the change in treatment satisfaction of participants who utilize the ACCU-CHEK Connect Diabetes Management System over a period of 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACCU-CHEK | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACCU-CHEK | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lena Borsa | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montgomery | Alabama | 36105 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29027812 | Derived | Mora P, Buskirk A, Lyden M, Parkin CG, Borsa L, Petersen B. Use of a Novel, Remotely Connected Diabetes Management System Is Associated with Increased Treatment Satisfaction, Reduced Diabetes Distress, and Improved Glycemic Control in Individuals with Insulin-Treated Diabetes: First Results from the Personal Diabetes Management Study. Diabetes Technol Ther. 2017 Dec;19(12):715-722. doi: 10.1089/dia.2017.0206. Epub 2017 Oct 13. |
Not provided
Not provided
Not provided
Participants were identified and recruited from the investigators' established subject populations or from the subject populations of other physicians within the group practice, using protocol-specified inclusion and exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ACCU-CHEK | All participants utilized 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population included the full analysis set (FAS), 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 study, and had completed the Diabetes Treatment Satisfaction Questionnaire (DTSQc) at Week 24.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ACCU-CHEK | All participants utilized 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 24 |
|
24 weeks
The Safety Population included all participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACCU-CHEK | All participants utilized 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA Version 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA Version 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, Week 24 |
| Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 | Assessment of HbA1c is an indicator of long-term control of diabetes. | Baseline, Weeks 12 and 24 |
| Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range | Glucose target range was specified as 70-180 milligrams per deciliter (mg/dL). | Baseline, Week 24 |
| Change From Baseline to Week 24 in Mean Blood Glucose Level | Blood glucose is a type of sugar in blood and is measured to assess a participant's control of diabetes. | Baseline, Week 24 |
| Change From Baseline to Week 24 in Glycemic Variability | 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. | Baseline, Week 24 |
| Incidence of Hypoglycemia | 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. | Baseline, Weeks 12 and 24 |
| Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24 | Competency was defined as appropriate response to high and low glucose values. | Week 24 |
| Percent of Follow-Up Visits With Sufficient SMBG Data | Sufficient SMBG data is based on the ability of the healthcare provider to make informed decisions regarding therapy adjustments. | Up to Week 24 |
| Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24 | An increase in the number of blood glucose checks indicates more glycemic control. | Baseline, Weeks 12 and 24 |
| Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at 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. | Baseline, Weeks 12 and 24 |
| Percentage of Blood Glucose Tagged Data | 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. | Weeks 12 and 24 |
| Huntington Beach |
| California |
| 92648 |
| United States |
| Atlanta | Georgia | 30318 | United States |
| Macon | Georgia | 31210 | United States |
| Ocean Springs | Mississippi | 39564 | United States |
| Lincoln | Nebraska | 68521 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Pottstown | Pennsylvania | 19464 | United States |
| Bristol | Tennessee | 37620 | United States |
| Plano | Texas | 75075 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 | Assessment of HbA1c is an indicator of long-term control of diabetes. | 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. | Posted | Mean | Standard Deviation | percent | Baseline, Weeks 12 and 24 |
|
|
|
| Secondary | Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range | Glucose target range was specified as 70-180 milligrams per deciliter (mg/dL). | 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. | Posted | Mean | Standard Deviation | percent | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Mean Blood Glucose Level | Blood glucose is a type of sugar in blood and is measured to assess a participant's control of diabetes. | 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. | Posted | Mean | Standard Deviation | milligrams per deciliter | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Glycemic Variability | 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. | 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. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline, Week 24 |
|
|
|
| Secondary | Incidence of Hypoglycemia | 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. | 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. | Posted | Mean | Standard Deviation | hypoglycemic readings | Baseline, Weeks 12 and 24 |
|
|
|
| Secondary | Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24 | Competency was defined as appropriate response to high and low glucose values. | 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. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | Percent of Follow-Up Visits With Sufficient SMBG Data | Sufficient SMBG data is based on the ability of the healthcare provider to make informed decisions regarding therapy adjustments. | 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. | Posted | Mean | Standard Deviation | percentage of follow-up visits | Up to Week 24 |
|
|
|
| Secondary | Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24 | An increase in the number of blood glucose checks indicates more glycemic control. | 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. | Posted | Mean | Standard Deviation | blood glucose checks | Baseline, Weeks 12 and 24 |
|
|
|
| Secondary | Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at 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. | 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. | Posted | Mean | Standard Deviation | glucose checks per day | Baseline, Weeks 12 and 24 |
|
|
|
| Secondary | Percentage of Blood Glucose Tagged Data | 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. | 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. | Posted | Mean | Standard Deviation | percentage | Weeks 12 and 24 |
|
|
|
| 8 |
| 122 |
| 18 |
| 122 |
| Coronary artery disease | Cardiac disorders | MedDRA Version 18.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA Version 18.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 18.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 18.1 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | Systematic Assessment |
|
| Melanoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.1 | Systematic Assessment |
|
| Arachnoiditis | Nervous system disorders | MedDRA Version 18.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| Week 24 |
|
|
|