Trial Outcomes & Findings for Accu-Chek® CONNECT at School (CATS) Pediatric Study (NCT NCT02609633)
NCT ID: NCT02609633
Last Updated: 2018-05-18
Results Overview
The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.
COMPLETED
NA
196 participants
Baseline, Month 6
2018-05-18
Participant Flow
Families of participants were identified and recruited from the investigators' established participant populations or from the participant populations of other physicians within the group practice, using protocol-specified inclusion and exclusion criteria.
Although a total of 196 parents and children/adolescents were enrolled, only the 98 children/adolescents were considered participants in the study. Baseline and adverse events data were only collected for children/adolescents.
Participant milestones
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
56
|
|
Overall Study
Full Analysis Set (FAS)
|
32
|
46
|
|
Overall Study
COMPLETED
|
37
|
54
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Overall Study
Consent Withdrawn
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
|
Overall Study
Non-Compliant with Study Procedures
|
2
|
0
|
|
Overall Study
Reason not Specified
|
2
|
1
|
Baseline Characteristics
Accu-Chek® CONNECT at School (CATS) Pediatric Study
Baseline characteristics by cohort
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=32 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=46 Participants
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.3 years
STANDARD_DEVIATION 3.06 • n=5 Participants
|
12.6 years
STANDARD_DEVIATION 3.03 • n=7 Participants
|
12.9 years
STANDARD_DEVIATION 3.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic/latino:Yes
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic/latino:No
|
30 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Diabetes-Related Distress According to the PAID Child and Teen (C&T) Parent Questionnaire Score
|
66.2 Score on a Scale
STANDARD_DEVIATION 21.72 • n=5 Participants
|
71.1 Score on a Scale
STANDARD_DEVIATION 24.53 • n=7 Participants
|
69.1 Score on a Scale
STANDARD_DEVIATION 23.40 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4.
The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=32 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=46 Participants
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the Problem Areas in Diabetes (PAID) Child and Teen (C&T) Parent Questionnaire Score at Month 6
|
-0.3 score on a scale
Standard Deviation 17.82
|
-5.0 score on a scale
Standard Deviation 21.42
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.
The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=32 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=46 Participants
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3
Baseline
|
65.3 score on a scale
Standard Deviation 21.42
|
70.4 score on a scale
Standard Deviation 24.14
|
|
Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3
Change at Month 3
|
4.7 score on a scale
Standard Deviation 18.06
|
-1.3 score on a scale
Standard Deviation 19.14
|
SECONDARY outcome
Timeframe: Baseline, Months 3 and 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.
The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=32 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=46 Participants
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Change From Baseline in Diabetes-Related Distress Among School-age Children/Adolescents and Adolescents According to the PAID C&T Child Questionnaire Score at Month 3 and 6
Baseline
|
53.1 score on a scale
Standard Deviation 26.85
|
62.2 score on a scale
Standard Deviation 24.44
|
|
Change From Baseline in Diabetes-Related Distress Among School-age Children/Adolescents and Adolescents According to the PAID C&T Child Questionnaire Score at Month 3 and 6
Change at Months 3
|
-3.0 score on a scale
Standard Deviation 16.89
|
1.2 score on a scale
Standard Deviation 17.44
|
|
Change From Baseline in Diabetes-Related Distress Among School-age Children/Adolescents and Adolescents According to the PAID C&T Child Questionnaire Score at Month 3 and 6
Change at Months 6
|
-2.1 score on a scale
Standard Deviation 18.00
|
-0.2 score on a scale
Standard Deviation 17.98
|
SECONDARY outcome
Timeframe: Baseline, Months 3 and 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. The number analysed is the participants who were evaluable for this outcome measure.
The DFCS Questionnaire has 19 questions, each question ranges in response values between 1 ("Almost Never") and 3 ("Almost Always"). The derived total score (19 questions) ranges between 19 and 57, where higher score indicates worsened condition. This questionnaire was answered by Children/adolescents and Parents.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=32 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=46 Participants
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6
Children/adolescents DFCS Score at Baseline
|
28.3 score on a scale
Standard Deviation 10.54
|
30.3 score on a scale
Standard Deviation 9.57
|
|
Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6
Children/adolescents DFCS Change Score at Month 3
|
0.5 score on a scale
Standard Deviation 11.23
|
-0.5 score on a scale
Standard Deviation 9.37
|
|
Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6
Children/adolescents DFCS Change Score at Month 6
|
-0.8 score on a scale
Standard Deviation 12.09
|
-0.9 score on a scale
Standard Deviation 7.93
|
|
Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6
Parent/Caregiver DFCS Score at Baseline
|
27.9 score on a scale
Standard Deviation 9.13
|
27.6 score on a scale
Standard Deviation 8.37
|
|
Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6
Parent/Caregiver DFCS Change Score at Month 3
|
-1.6 score on a scale
Standard Deviation 8.02
|
-1.3 score on a scale
Standard Deviation 6.15
|
|
Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6
Parent/Caregiver DFCS Change Score at Month 6
|
-0.2 score on a scale
Standard Deviation 7.93
|
-1.6 score on a scale
Standard Deviation 9.73
|
SECONDARY outcome
Timeframe: Baseline, Months 3 and 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analysed' is the participants who were evaluable for this outcome measure.
The BGMC Questionnaire has 8 questions, each question ranges in response values from 1 ("Almost Never") to 3 ("Almost Always"). The derived total score ranges between 8 and 24, where higher score indicates worsened condition.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=32 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=46 Participants
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6
Children/Adolescents BGMC Score at Baseline
|
12.4 score on a scale
Standard Deviation 4.01
|
13.7 score on a scale
Standard Deviation 3.85
|
|
Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6
Children/Adolescents BGMC Change Score at Month 3
|
-0.9 score on a scale
Standard Deviation 2.86
|
-0.1 score on a scale
Standard Deviation 3.01
|
|
Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6
Children/Adolescents BGMC Change Score at Month 6
|
-0.4 score on a scale
Standard Deviation 4.09
|
-0.4 score on a scale
Standard Deviation 2.90
|
|
Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6
Parents/Caregivers BGMC Score at Baseline
|
14.4 score on a scale
Standard Deviation 3.45
|
14.0 score on a scale
Standard Deviation 4.03
|
|
Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6
Parents/Caregivers BGMC Change Score at Month 3
|
0.3 score on a scale
Standard Deviation 2.38
|
-0.7 score on a scale
Standard Deviation 3.53
|
|
Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6
Parents/Caregivers BGMC Score Change at Month 6
|
-0.5 score on a scale
Standard Deviation 2.80
|
-0.3 score on a scale
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: Baseline, Months 3 and 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.
Assessment of HbA1c is an indicator of long-term control of diabetes.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=32 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=46 Participants
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6
Baseline
|
9.3 percentage of glycated hemoglobin
Standard Deviation 1.81
|
9.1 percentage of glycated hemoglobin
Standard Deviation 1.80
|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6
Change at Month 3
|
-0.1 percentage of glycated hemoglobin
Standard Deviation 0.94
|
-0.1 percentage of glycated hemoglobin
Standard Deviation 1.25
|
|
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6
Change at Month 6
|
-0.1 percentage of glycated hemoglobin
Standard Deviation 1.10
|
-0.1 percentage of glycated hemoglobin
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: Baseline, Months 3 and 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. The number analysed is the participants who were evaluable for this outcome measure.
The percentage of target range measurements was defined as the number of within target range readings in the interval divided by the total number of BG checks in the interval.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=32 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=46 Participants
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range
Target Range 70-160 mg/dl: Baseline
|
39.0 percentage of blood glucose measurements
Standard Deviation 18.91
|
30.0 percentage of blood glucose measurements
Standard Deviation 19.42
|
|
Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range
Target Range 70-160 mg/dl: Change at Month 3
|
-3.9 percentage of blood glucose measurements
Standard Deviation 25.56
|
2.8 percentage of blood glucose measurements
Standard Deviation 12.46
|
|
Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range
Target Range 70-160 mg/dl: Change at Month 6
|
-4.8 percentage of blood glucose measurements
Standard Deviation 22.13
|
0.5 percentage of blood glucose measurements
Standard Deviation 15.60
|
|
Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range
Target Range 80-180 mg/dl: Baseline
|
41.4 percentage of blood glucose measurements
Standard Deviation 19.03
|
31.9 percentage of blood glucose measurements
Standard Deviation 20.26
|
|
Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range
Target Range 80-180 mg/dl: Change at Month 3
|
-4.6 percentage of blood glucose measurements
Standard Deviation 25.60
|
3.8 percentage of blood glucose measurements
Standard Deviation 12.99
|
|
Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range
Target Range 80-180 mg/dl: Change at Month 6
|
-4.2 percentage of blood glucose measurements
Standard Deviation 22.68
|
1.4 percentage of blood glucose measurements
Standard Deviation 14.96
|
SECONDARY outcome
Timeframe: Baseline, Months 3 and 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analysed' is the participants who were evaluable for this outcome measure.
Glycemic variability, expressed as mean of all blood glucose(BG) readings per subject within the interval. BG variability was defined as standard deviation (SD) of all glucose readings over the interval.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=32 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=46 Participants
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6
Baseline
|
94.0 milligrams per deciliter (mg/dl)
Standard Deviation 30.84
|
99.2 milligrams per deciliter (mg/dl)
Standard Deviation 32.38
|
|
Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6
Change at Month 3
|
-1.3 milligrams per deciliter (mg/dl)
Standard Deviation 30.47
|
-2.3 milligrams per deciliter (mg/dl)
Standard Deviation 21.78
|
|
Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6
Change at Month 6
|
2.8 milligrams per deciliter (mg/dl)
Standard Deviation 20.39
|
-3.4 milligrams per deciliter (mg/dl)
Standard Deviation 23.48
|
SECONDARY outcome
Timeframe: Baseline, Months 3 and 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.
A measurement was defined as hypoglycemic if the glucose value was below 70 mg/dl or below 60 mg/dl or below 50 mg/dl.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=32 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=46 Participants
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
Hypoglycemia (< 50 mg/dl): Change at Month 6
|
0.1 percentage of hypoglycemic measurements
Standard Deviation 3.21
|
-0.6 percentage of hypoglycemic measurements
Standard Deviation 3.98
|
|
Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
Hypoglycemia (< 70 mg/dl): Baseline
|
4.4 percentage of hypoglycemic measurements
Standard Deviation 6.20
|
5.4 percentage of hypoglycemic measurements
Standard Deviation 6.64
|
|
Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
Hypoglycemia (< 70 mg/dl) Change at Months 3
|
1.7 percentage of hypoglycemic measurements
Standard Deviation 7.07
|
0.1 percentage of hypoglycemic measurements
Standard Deviation 7.55
|
|
Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
Hypoglycemia (< 70 mg/dl): Change at Months 6
|
1.3 percentage of hypoglycemic measurements
Standard Deviation 6.22
|
1.6 percentage of hypoglycemic measurements
Standard Deviation 9.04
|
|
Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
Hypoglycemia (< 60 mg/dl): Baseline
|
2.2 percentage of hypoglycemic measurements
Standard Deviation 4.28
|
2.8 percentage of hypoglycemic measurements
Standard Deviation 4.64
|
|
Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
Hypoglycemia (< 60 mg/dl): Change at Month 3
|
0.8 percentage of hypoglycemic measurements
Standard Deviation 5.03
|
-0.0 percentage of hypoglycemic measurements
Standard Deviation 5.53
|
|
Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
Hypoglycemia (< 60 mg/dl): Change at Month 6
|
0.5 percentage of hypoglycemic measurements
Standard Deviation 5.10
|
0.1 percentage of hypoglycemic measurements
Standard Deviation 6.37
|
|
Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
Hypoglycemia (< 50 mg/dl): Baseline
|
1.0 percentage of hypoglycemic measurements
Standard Deviation 2.76
|
1.4 percentage of hypoglycemic measurements
Standard Deviation 3.45
|
|
Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
Hypoglycemia (< 50 mg/dl): Change at Month 3
|
-0.4 percentage of hypoglycemic measurements
Standard Deviation 3.08
|
-0.5 percentage of hypoglycemic measurements
Standard Deviation 3.74
|
SECONDARY outcome
Timeframe: Month 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analyzed' is the participants who were evaluable for this outcome measure.
Percentage of participants who frequently used Accu-Chek® CONNECT Diabetes Management System (blood sugar meter \[BSM\], phone application \[PA\] and web portal \[WP\]) according to the questionnaire about usability answered by children/adolescents and Parent were reported. Here, in parent post questionnaire for usability the sum of percentages are not equal to 100%, because percentage is based on n=44.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=46 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Parents: WP - Frequently Not Used
|
43.2 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Children/Adolescents: BSM - Frequently Used
|
97.6 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Children/Adolescents: BSM - Frequently Not Used
|
2.4 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Children/Adolescents: PA - Frequently Used
|
78.0 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Children/Adolescents: PA - Frequently Not Used
|
22.0 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Children/Adolescents: WP - Frequently Used
|
36.6 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Children/Adolescents: WP - Frequently Not Used
|
63.4 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Parents: BSM - Frequently Used
|
86.4 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Parents: BSM - Frequently Not Used
|
13.6 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Parents: PA - Frequently Used
|
79.5 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Parents: PA - Frequently Not Used
|
18.2 percentage of participants
|
—
|
|
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Parents: WP - Frequently Used
|
47.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analyzed' is the participants who were evaluable for this outcome measure.
Participants preference the Accu-Chek® CONNECT process compared with previous technology/process assessed by questionnaire including following questions; Q 1: Felt more sure of myself using the system, Q 2: Less worried about low BG than used to be, Q 3: Would rather use the system than what used before, Q 4: Felt safer managing diabetes using system than what used before, Q 5: Friends with diabetes should also use the system. Questionnaire was answered by children/adolescents and parents. Here, in children/adolescents post questionnaire for preference the percentage sum is not equal to 100%, because percentage is based on n=41.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=46 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Children/Adolescents: Q 1- Mostly Agree
|
90.2 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Children/Adolescents: Q 1- Mostly Disagree
|
7.3 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Children/Adolescents: Q 2- Mostly Agree
|
90.2 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Children/Adolescents: Q 2- Mostly Disagree
|
9.8 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Children/Adolescents: Q 3- Mostly Agree
|
90.2 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Children/Adolescents: Q 3- Mostly Disagree
|
9.8 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Children/Adolescents: Q 4- Mostly Agree
|
90.2 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Children/Adolescents: Q 4- Mostly Disagree
|
9.8 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Children/Adolescents: Q 5- Mostly Agree
|
85.4 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Children/Adolescents: Q 5- Mostly Disagree
|
14.6 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Parent: Q 1- Mostly Agree
|
90.9 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Parent: Q 1- Mostly Disagree
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Parent: Q 2- Mostly Agree
|
88.6 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Parent: Q 2- Mostly Disagree
|
11.4 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Parent: Q 3- Mostly Agree
|
90.9 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Parent: Q 3- Mostly Disagree
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Parent: Q 4- Mostly Agree
|
90.9 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Parent: Q 4- Mostly Disagree
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Parent: Q 5- Mostly Agree
|
95.5 percentage of participants
|
—
|
|
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Parent: Q 5- Mostly Disagree
|
4.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analyzed' is the participants who were evaluable for this outcome measure.
Percentage of participants with overall treatment satisfaction with the use of Accu-Chek® CONNECT Diabetes Management system according to the questionnaire answered by children/adolescents and parents were reported.
Outcome measures
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=46 Participants
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire
Children/adolescents: Satisfied
|
87.8 percentage of participants
|
—
|
|
Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire
Children/adolescents: Not Satisfied
|
9.8 percentage of participants
|
—
|
|
Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire
Parent: Satisfied
|
88.4 percentage of participants
|
—
|
|
Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire
Parent: Not Satisfied
|
4.7 percentage of participants
|
—
|
Adverse Events
Control: Usual Care - Current Diabetes Management System (DMS)
Interventional: Accu-Chek® CONNECT DMS
Serious adverse events
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=42 participants at risk
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=56 participants at risk
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Baseline up to Month 6
The Safety Population included all participants.
|
0.00%
0/56 • Baseline up to Month 6
The Safety Population included all participants.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/42 • Baseline up to Month 6
The Safety Population included all participants.
|
1.8%
1/56 • Baseline up to Month 6
The Safety Population included all participants.
|
|
Infections and infestations
Gastroenteritis viral
|
4.8%
2/42 • Baseline up to Month 6
The Safety Population included all participants.
|
0.00%
0/56 • Baseline up to Month 6
The Safety Population included all participants.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
2.4%
1/42 • Baseline up to Month 6
The Safety Population included all participants.
|
1.8%
1/56 • Baseline up to Month 6
The Safety Population included all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.4%
1/42 • Baseline up to Month 6
The Safety Population included all participants.
|
0.00%
0/56 • Baseline up to Month 6
The Safety Population included all participants.
|
Other adverse events
| Measure |
Control: Usual Care - Current Diabetes Management System (DMS)
n=42 participants at risk
Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.
|
Interventional: Accu-Chek® CONNECT DMS
n=56 participants at risk
Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
9.5%
4/42 • Baseline up to Month 6
The Safety Population included all participants.
|
0.00%
0/56 • Baseline up to Month 6
The Safety Population included all participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.9%
5/42 • Baseline up to Month 6
The Safety Population included all participants.
|
1.8%
1/56 • Baseline up to Month 6
The Safety Population included all participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
64.3%
27/42 • Baseline up to Month 6
The Safety Population included all participants.
|
8.9%
5/56 • Baseline up to Month 6
The Safety Population included all participants.
|
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