Trial Outcomes & Findings for ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT) (NCT NCT02600845)
NCT ID: NCT02600845
Last Updated: 2017-11-06
Results Overview
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.
COMPLETED
NA
122 participants
Week 24
2017-11-06
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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122
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Overall Study
COMPLETED
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104
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Overall Study
NOT COMPLETED
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18
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Reasons for withdrawal
| Measure |
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.
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Overall Study
Reason Not Specified
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3
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Overall Study
Non-compliance with Study Procedures
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10
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Overall Study
Consent Withdrawal
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5
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Baseline Characteristics
ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)
Baseline characteristics by cohort
| Measure |
ACCU-CHEK
n=87 Participants
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.
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Age, Continuous
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57.9 years
STANDARD_DEVIATION 12.04 • n=5 Participants
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Sex: Female, Male
Female
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45 Participants
n=5 Participants
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Sex: Female, Male
Male
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42 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
ACCU-CHEK
n=87 Participants
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.
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Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24
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14.3 score on a scale
Interval 13.2 to 15.4
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SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
Outcome measures
| Measure |
ACCU-CHEK
n=80 Participants
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.
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Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score
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-0.3 score on a scale
Interval -0.4 to -0.2
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SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: 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.
Outcome measures
| Measure |
ACCU-CHEK
n=85 Participants
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.
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Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
Week 12
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-1.07 percent
Standard Deviation 1.384
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Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
Week 24
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-0.95 percent
Standard Deviation 1.588
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SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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).
Outcome measures
| Measure |
ACCU-CHEK
n=73 Participants
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.
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Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range
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14.74 percent
Standard Deviation 34.018
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SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
Outcome measures
| Measure |
ACCU-CHEK
n=73 Participants
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.
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Change From Baseline to Week 24 in Mean Blood Glucose Level
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-24.79 milligrams per deciliter
Standard Deviation 50.813
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SECONDARY outcome
Timeframe: Baseline, Week 24Population: 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.
Outcome measures
| Measure |
ACCU-CHEK
n=73 Participants
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.
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Change From Baseline to Week 24 in Glycemic Variability
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-9.26 milligrams per deciliter (mg/dL)
Standard Deviation 19.244
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SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: 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.
Outcome measures
| Measure |
ACCU-CHEK
n=87 Participants
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.
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Incidence of Hypoglycemia
Baseline
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1.45 hypoglycemic readings
Standard Deviation 3.227
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Incidence of Hypoglycemia
Week 12
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1.08 hypoglycemic readings
Standard Deviation 2.151
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Incidence of Hypoglycemia
Week 24
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1.48 hypoglycemic readings
Standard Deviation 3.445
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SECONDARY outcome
Timeframe: Week 24Population: 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.
Outcome measures
| Measure |
ACCU-CHEK
n=97 Participants
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.
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Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24
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1 Participants
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SECONDARY outcome
Timeframe: Up to Week 24Population: 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.
Outcome measures
| Measure |
ACCU-CHEK
n=86 Participants
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.
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Percent of Follow-Up Visits With Sufficient SMBG Data
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91.71 percentage of follow-up visits
Standard Deviation 15.281
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SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: 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.
Outcome measures
| Measure |
ACCU-CHEK
n=73 Participants
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.
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|---|---|
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Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24
Week 12
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16.25 blood glucose checks
Standard Deviation 35.653
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Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24
Week 24
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9.37 blood glucose checks
Standard Deviation 35.132
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SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 24Population: 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 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.
Outcome measures
| Measure |
ACCU-CHEK
n=73 Participants
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.
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Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at Weeks 12 and 24
Week 12
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0.45 glucose checks per day
Standard Deviation 1.201
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Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at Weeks 12 and 24
Week 24
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0.22 glucose checks per day
Standard Deviation 1.205
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SECONDARY outcome
Timeframe: Weeks 12 and 24Population: 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.
Outcome measures
| Measure |
ACCU-CHEK
n=87 Participants
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.
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Percentage of Blood Glucose Tagged Data
Week 12
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84.24 percentage
Standard Deviation 24.461
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Percentage of Blood Glucose Tagged Data
Week 24
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86.87 percentage
Standard Deviation 21.545
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Adverse Events
ACCU-CHEK
Serious adverse events
| Measure |
ACCU-CHEK
n=122 participants at risk
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.
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Cardiac disorders
Angina pectoris
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0.82%
1/122 • 24 weeks
The Safety Population included all participants.
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Cardiac disorders
Coronary artery disease
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0.82%
1/122 • 24 weeks
The Safety Population included all participants.
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Infections and infestations
Gastrointestinal infection
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0.82%
1/122 • 24 weeks
The Safety Population included all participants.
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Infections and infestations
Sepsis
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1.6%
2/122 • 24 weeks
The Safety Population included all participants.
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Metabolism and nutrition disorders
Diabetic ketoacidosis
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0.82%
1/122 • 24 weeks
The Safety Population included all participants.
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Musculoskeletal and connective tissue disorders
Exostosis
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0.82%
1/122 • 24 weeks
The Safety Population included all participants.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
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0.82%
1/122 • 24 weeks
The Safety Population included all participants.
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Nervous system disorders
Arachnoiditis
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0.82%
1/122 • 24 weeks
The Safety Population included all participants.
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Other adverse events
| Measure |
ACCU-CHEK
n=122 participants at risk
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.
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|---|---|
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Metabolism and nutrition disorders
Hypoglycemia
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14.8%
18/122 • 24 weeks
The Safety Population included all participants.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER