Diabetes Mellitus, Type 1
Conditions
Brief summary
This interventional, 6-month post-marketing study is designed to evaluate the change in diabetes-related distress among parents/caregivers of school-age children and adolescents with type 1 diabetes (T1D) who are receiving multiple daily injections (MDI) therapy. Investigational sites will be assigned using cluster randomization, with approximately 10 to 20 children at each site. In order to maintain a true control group for comparison, the investigational sites will be randomly assigned to the Accu-Chek® CONNECT Diabetes Management System (DMS) or usual care/continued use of current DMS devices.
Interventions
DEVICEAccu-Chek® CONNECT DMS
SMBG will be performed during the 6-month study using the Accu-Chek® Aviva CONNECT monitoring device, and corresponding Smartphone app and online tracking tool.
DEVICEDMS
SMBG will be performed during the 6-month study according to usual care, using the participant's current DMS (other than Accu-Chek® CONNECT DMS).
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children or adolescents, aged 6 to 18 years * Diagnosis of T1D for at least 3 months * Currently managed with insulin Multiple Daily Injection (MDI) therapy * Attending full-day school schedule in Grade K through 12 * Able to provide SMBG data minimum of one month prior to study start * Currently using a compatible Smartphone with ability to download the Accu-Chek® CONNECT System App accordingly OR ability to utilize Smartphone and Accu-Chek® CONNECT System App as provided for use in study * Adolescents (18 years) with diabetes provide written informed consent * Children 7 to 17 years to provide age-appropriate child assent * Parent/caregiver currently using a compatible Smartphone with ability to receive Short Message Service/Multimedia Messaging Service (SMS/MMS) messages * Able to read/write in English and comply with study procedures, including provision of self-monitoring blood glucose (SMBG) data at least 1 month prior to the study
Exclusion criteria
* Current or planned use of continuous subcutaneous insulin infusions during the study period * Use of continuous glucose monitoring or a remote data-sharing system/device (i.e. NightScout, DexCom Share, Medtronic Connect) during the study * Pregnancy * Clinically significant medical condition(s) such as anemia, major organ system disease, infection, psychosis, or cognitive impairment * Requirement for chronic steroids, immunomodulatory medication, or chemotherapy in adrenal suppressive doses * Visual impairment preventing use of the Accu-Chek® CONNECT system * Parent/caregiver is an investigator, general practitioner, practice staff, pharmacist, research assistant, or other staff or relative of those directly involved in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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, Months 3 and 6 | 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. |
| 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 | Baseline, Months 3 and 6 | 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. |
| 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 | Baseline, Months 3 and 6 | 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. |
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6 | Baseline, Months 3 and 6 | Assessment of HbA1c is an indicator of long-term control of diabetes. |
| 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 | Baseline, Months 3 and 6 | 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. |
| Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3 | Baseline, Month 3 | 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. |
| Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6 | Baseline, Months 3 and 6 | 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. |
| Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability | Month 6 | 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. |
| Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process | Month 6 | 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. |
| Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire | Month 6 | 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. |
| Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6 | Baseline, Months 3 and 6 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Interventional: Accu-Chek® CONNECT DMS Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months. | 46 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent Withdrawn | 0 | 1 |
| Overall Study | Non-Compliant with Study Procedures | 2 | 0 |
| Overall Study | Protocol Deviation | 1 | 0 |
| Overall Study | Reason not Specified | 2 | 1 |
Baseline characteristics
| Characteristic | Control: Usual Care - Current Diabetes Management System (DMS) | Interventional: Accu-Chek® CONNECT DMS | Total |
|---|---|---|---|
| Age, Continuous | 13.3 years STANDARD_DEVIATION 3.06 | 12.6 years STANDARD_DEVIATION 3.03 | 12.9 years STANDARD_DEVIATION 3.04 |
| 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 | 71.1 Score on a Scale STANDARD_DEVIATION 24.53 | 69.1 Score on a Scale STANDARD_DEVIATION 23.4 |
| Race/Ethnicity, Customized Ethnicity Hispanic/latino:No | 30 Participants | 42 Participants | 72 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic/latino:Yes | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Race White | 24 Participants | 34 Participants | 58 Participants |
| Sex: Female, Male Female | 13 Participants | 24 Participants | 37 Participants |
| Sex: Female, Male Male | 19 Participants | 22 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 56 |
| other Total, other adverse events | 28 / 42 | 6 / 56 |
| serious Total, serious adverse events | 4 / 42 | 2 / 56 |
Outcome results
Primary
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
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.
Time frame: Baseline, Month 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -5.0 score on a scale | Standard Deviation 21.42 |
Secondary
Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6
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.
Time frame: Baseline, Months 3 and 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Interventional: Accu-Chek® CONNECT DMS | Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6 | Baseline | 99.2 milligrams per deciliter (mg/dl) | Standard Deviation 32.38 |
| Interventional: Accu-Chek® CONNECT DMS | Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6 | Change at Month 3 | -2.3 milligrams per deciliter (mg/dl) | Standard Deviation 21.78 |
| Interventional: Accu-Chek® CONNECT DMS | Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6 | Change at Month 6 | -3.4 milligrams per deciliter (mg/dl) | Standard Deviation 23.48 |
Secondary
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
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.
Time frame: Baseline, Months 3 and 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 2.8 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 14.0 score on a scale | Standard Deviation 4.03 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -0.3 score on a scale | Standard Deviation 4.39 |
| Interventional: Accu-Chek® CONNECT DMS | 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 2.9 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 13.7 score on a scale | Standard Deviation 3.85 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -0.7 score on a scale | Standard Deviation 3.53 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -0.1 score on a scale | Standard Deviation 3.01 |
Secondary
Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3
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.
Time frame: Baseline, Month 3
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Interventional: Accu-Chek® CONNECT DMS | Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3 | Baseline | 70.4 score on a scale | Standard Deviation 24.14 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -1.3 score on a scale | Standard Deviation 19.14 |
Secondary
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
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.
Time frame: Baseline, Months 3 and 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 62.2 score on a scale | Standard Deviation 24.44 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 1.2 score on a scale | Standard Deviation 17.44 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -0.2 score on a scale | Standard Deviation 17.98 |
Secondary
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6
Assessment of HbA1c is an indicator of long-term control of diabetes.
Time frame: Baseline, Months 3 and 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 1.1 |
| Interventional: Accu-Chek® CONNECT DMS | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6 | Baseline | 9.1 percentage of glycated hemoglobin | Standard Deviation 1.8 |
| Interventional: Accu-Chek® CONNECT DMS | 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 1.25 |
| Interventional: Accu-Chek® CONNECT DMS | 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 1.44 |
Secondary
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
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.
Time frame: Baseline, Months 3 and 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -1.3 score on a scale | Standard Deviation 6.15 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 30.3 score on a scale | Standard Deviation 9.57 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 27.6 score on a scale | Standard Deviation 8.37 |
| Interventional: Accu-Chek® CONNECT DMS | 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 9.37 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -1.6 score on a scale | Standard Deviation 9.73 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -0.9 score on a scale | Standard Deviation 7.93 |
Secondary
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
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.
Time frame: Baseline, Months 3 and 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 25.6 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 3.8 percentage of blood glucose measurements | Standard Deviation 12.99 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 30.0 percentage of blood glucose measurements | Standard Deviation 19.42 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 31.9 percentage of blood glucose measurements | Standard Deviation 20.26 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 2.8 percentage of blood glucose measurements | Standard Deviation 12.46 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 1.4 percentage of blood glucose measurements | Standard Deviation 14.96 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 0.5 percentage of blood glucose measurements | Standard Deviation 15.6 |
Secondary
Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
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.
Time frame: Baseline, Months 3 and 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 6.2 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 5.1 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -0.6 percentage of hypoglycemic measurements | Standard Deviation 3.98 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 5.4 percentage of hypoglycemic measurements | Standard Deviation 6.64 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 0.1 percentage of hypoglycemic measurements | Standard Deviation 7.55 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 1.6 percentage of hypoglycemic measurements | Standard Deviation 9.04 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 2.8 percentage of hypoglycemic measurements | Standard Deviation 4.64 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 0.1 percentage of hypoglycemic measurements | Standard Deviation 6.37 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | 1.4 percentage of hypoglycemic measurements | Standard Deviation 3.45 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -0.5 percentage of hypoglycemic measurements | Standard Deviation 3.74 |
| Interventional: Accu-Chek® CONNECT DMS | 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 | -0.0 percentage of hypoglycemic measurements | Standard Deviation 5.53 |
Secondary
Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
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.
Time frame: Month 6
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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
Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire
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.
Time frame: Month 6
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
Secondary
Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
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.
Time frame: Month 6
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |
| Control: Usual Care - Current Diabetes Management System (DMS) | 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 |