Accu-Chek® CONNECT at School (CATS) Pediatric Study

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02609633
• Collaborator: (none)
• Enrollment: 196
• Locations: 13
• Arms: 2
• Actual Duration (Months): 12.8
• Patients Per Site: 15.1
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Device: Accu-Chek® CONNECT DMS; Device: DMS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Accu-Chek® CONNECT at School (CATS) Pediatric Study
• Actual Study Start Date: Dec 28, 2015
• Actual Primary Completion Date: Jan 20, 2017
• Actual Study Completion Date: Jan 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control: Usual Care - Current Diabetes Management System (DMS) Participants will perform self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device. Follow-up office visits will be scheduled at Months 3 and 6 to review and discuss SMBG data and modify the type 1 diabetes (T1D) regimen as needed.	Device: DMS; 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).
Experimental: Interventional: Accu-Chek® CONNECT DMS Participants will receive training on Day 1 with the Accu-Chek® CONNECT DMS and will thereafter perform SMBG for 6 months. Follow-up office visits will be scheduled at Months 3 and 6 to review and discuss SMBG data and modify the T1D regimen as needed.	Device: Accu-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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric Endocrinology of Phoenix	Phoenix	Arizona	United States	85053
2	Center of Excellence in Diabetes and Endocrinology	Sacramento	California	United States	95821
3	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado	United States	80045
4	Nemours Childrens Hospital	Pensacola	Florida	United States	32504
5	Tallahassee Memorial Hospital	Tallahassee	Florida	United States	32308
6	University of South Florida College of Medicine	Tampa	Florida	United States	33612
7	Pediatric Endocrine Associates	Atlanta	Georgia	United States	30342
8	Rocky Mountain Diabetes & Osteoporosis Center	Idaho Falls	Idaho	United States	83404
9	Advocate Center for Pediatric Research	Oak Lawn	Illinois	United States	60453
10	Indiana University Riley	Carmel	Indiana	United States	46032
11	Childrens Hospital and Clinics of Minnesota	Saint Paul	Minnesota	United States	55102
12	Women and Children's Hospital of Buffalo	Buffalo	New York	United States	14222
13	East Caroline University - Pediatric specialty Care	Greenville	North Carolina	United States	27834

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Lena Borsa, Roche Diabetes Care GmbH

Study Documents (Full-Text)

• Study Protocol - Aug 27, 2015
• Statistical Analysis Plan - Jun 27, 2016

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02609633
• Other Study ID Numbers: RD002489
• First Posted: Nov 20, 2015
• Last Update Posted: May 18, 2018
• Last Verified: Apr 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Diabetes Mellitus, Type 1

Study Results

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 Detail	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.

Arm/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Period Title: Overall Study
STARTED	42	56
Full Analysis Set (FAS)	32	46
COMPLETED	37	54
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS	Total
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.	Total of all reporting groups
Overall Participants	32	46	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13.3 (3.06)	12.6 (3.03)	12.9 (3.04)
Sex: Female, Male (Count of Participants)
Female	13 40.6%	24 52.2%	37 47.4%
Male	19 59.4%	22 47.8%	41 52.6%
Race/Ethnicity, Customized (Count of Participants)
Black or African American	6 18.8%	5 10.9%	11 14.1%
White	24 75%	34 73.9%	58 74.4%
Asian	0 0%	1 2.2%	1 1.3%
Native Hawaiian or other Pacific Islander	0 0%	1 2.2%	1 1.3%
Other	2 6.3%	5 10.9%	7 9%
Race/Ethnicity, Customized (Count of Participants)
Hispanic/latino:Yes	2 6.3%	4 8.7%	6 7.7%
Hispanic/latino:No	30 93.8%	42 91.3%	72 92.3%
Diabetes-Related Distress According to the PAID Child and Teen (C&T) Parent Questionnaire Score (Score on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score on a Scale]	66.2 (21.72)	71.1 (24.53)	69.1 (23.40)

Outcome Measures

1. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	32	46
Mean (Standard Deviation) [score on a scale]	-0.3 (17.82)	-5.0 (21.42)

2. Secondary Outcome

Title	Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	32	46
Baseline	65.3 (21.42)	70.4 (24.14)
Change at Month 3	4.7 (18.06)	-1.3 (19.14)

3. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	32	46
Baseline	53.1 (26.85)	62.2 (24.44)
Change at Months 3	-3.0 (16.89)	1.2 (17.44)
Change at Months 6	-2.1 (18.00)	-0.2 (17.98)

4. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	32	46
Children/adolescents DFCS Score at Baseline	28.3 (10.54)	30.3 (9.57)
Children/adolescents DFCS Change Score at Month 3	0.5 (11.23)	-0.5 (9.37)
Children/adolescents DFCS Change Score at Month 6	-0.8 (12.09)	-0.9 (7.93)
Parent/Caregiver DFCS Score at Baseline	27.9 (9.13)	27.6 (8.37)
Parent/Caregiver DFCS Change Score at Month 3	-1.6 (8.02)	-1.3 (6.15)
Parent/Caregiver DFCS Change Score at Month 6	-0.2 (7.93)	-1.6 (9.73)

5. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	32	46
Children/Adolescents BGMC Score at Baseline	12.4 (4.01)	13.7 (3.85)
Children/Adolescents BGMC Change Score at Month 3	-0.9 (2.86)	-0.1 (3.01)
Children/Adolescents BGMC Change Score at Month 6	-0.4 (4.09)	-0.4 (2.90)
Parents/Caregivers BGMC Score at Baseline	14.4 (3.45)	14.0 (4.03)
Parents/Caregivers BGMC Change Score at Month 3	0.3 (2.38)	-0.7 (3.53)
Parents/Caregivers BGMC Score Change at Month 6	-0.5 (2.80)	-0.3 (4.39)

6. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6
Description	Assessment of HbA1c is an indicator of long-term control of diabetes.
Time Frame	Baseline, Months 3 and 6

Outcome Measure Data

Analysis Population Description

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/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	32	46
Baseline	9.3 (1.81)	9.1 (1.80)
Change at Month 3	-0.1 (0.94)	-0.1 (1.25)
Change at Month 6	-0.1 (1.10)	-0.1 (1.44)

7. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	32	46
Target Range 70-160 mg/dl: Baseline	39.0 (18.91)	30.0 (19.42)
Target Range 70-160 mg/dl: Change at Month 3	-3.9 (25.56)	2.8 (12.46)
Target Range 70-160 mg/dl: Change at Month 6	-4.8 (22.13)	0.5 (15.60)
Target Range 80-180 mg/dl: Baseline	41.4 (19.03)	31.9 (20.26)
Target Range 80-180 mg/dl: Change at Month 3	-4.6 (25.60)	3.8 (12.99)
Target Range 80-180 mg/dl: Change at Month 6	-4.2 (22.68)	1.4 (14.96)

8. Secondary Outcome

Title	Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	32	46
Baseline	94.0 (30.84)	99.2 (32.38)
Change at Month 3	-1.3 (30.47)	-2.3 (21.78)
Change at Month 6	2.8 (20.39)	-3.4 (23.48)

9. Secondary Outcome

Title	Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	32	46
Hypoglycemia (< 70 mg/dl): Baseline	4.4 (6.20)	5.4 (6.64)
Hypoglycemia (< 70 mg/dl) Change at Months 3	1.7 (7.07)	0.1 (7.55)
Hypoglycemia (< 70 mg/dl): Change at Months 6	1.3 (6.22)	1.6 (9.04)
Hypoglycemia (< 60 mg/dl): Baseline	2.2 (4.28)	2.8 (4.64)
Hypoglycemia (< 60 mg/dl): Change at Month 3	0.8 (5.03)	-0.0 (5.53)
Hypoglycemia (< 60 mg/dl): Change at Month 6	0.5 (5.10)	0.1 (6.37)
Hypoglycemia (< 50 mg/dl): Baseline	1.0 (2.76)	1.4 (3.45)
Hypoglycemia (< 50 mg/dl): Change at Month 3	-0.4 (3.08)	-0.5 (3.74)
Hypoglycemia (< 50 mg/dl): Change at Month 6	0.1 (3.21)	-0.6 (3.98)

10. Secondary Outcome

Title	Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	46
Children/Adolescents: BSM - Frequently Used	97.6 305%
Children/Adolescents: BSM - Frequently Not Used	2.4 7.5%
Children/Adolescents: PA - Frequently Used	78.0 243.8%
Children/Adolescents: PA - Frequently Not Used	22.0 68.8%
Children/Adolescents: WP - Frequently Used	36.6 114.4%
Children/Adolescents: WP - Frequently Not Used	63.4 198.1%
Parents: BSM - Frequently Used	86.4 270%
Parents: BSM - Frequently Not Used	13.6 42.5%
Parents: PA - Frequently Used	79.5 248.4%
Parents: PA - Frequently Not Used	18.2 56.9%
Parents: WP - Frequently Used	47.7 149.1%
Parents: WP - Frequently Not Used	43.2 135%

11. Secondary Outcome

Title	Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	46
Children/Adolescents: Q 1- Mostly Agree	90.2 281.9%
Children/Adolescents: Q 1- Mostly Disagree	7.3 22.8%
Children/Adolescents: Q 2- Mostly Agree	90.2 281.9%
Children/Adolescents: Q 2- Mostly Disagree	9.8 30.6%
Children/Adolescents: Q 3- Mostly Agree	90.2 281.9%
Children/Adolescents: Q 3- Mostly Disagree	9.8 30.6%
Children/Adolescents: Q 4- Mostly Agree	90.2 281.9%
Children/Adolescents: Q 4- Mostly Disagree	9.8 30.6%
Children/Adolescents: Q 5- Mostly Agree	85.4 266.9%
Children/Adolescents: Q 5- Mostly Disagree	14.6 45.6%
Parent: Q 1- Mostly Agree	90.9 284.1%
Parent: Q 1- Mostly Disagree	9.1 28.4%
Parent: Q 2- Mostly Agree	88.6 276.9%
Parent: Q 2- Mostly Disagree	11.4 35.6%
Parent: Q 3- Mostly Agree	90.9 284.1%
Parent: Q 3- Mostly Disagree	9.1 28.4%
Parent: Q 4- Mostly Agree	90.9 284.1%
Parent: Q 4- Mostly Disagree	9.1 28.4%
Parent: Q 5- Mostly Agree	95.5 298.4%
Parent: Q 5- Mostly Disagree	4.5 14.1%

12. Secondary Outcome

Title	Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
Measure Participants	46
Children/adolescents: Satisfied	87.8 274.4%
Children/adolescents: Not Satisfied	9.8 30.6%
Parent: Satisfied	88.4 276.3%
Parent: Not Satisfied	4.7 14.7%

Adverse Events

Time Frame	Baseline up to Month 6
Adverse Event Reporting Description	The Safety Population included all participants.
Arm/Group Title	Control: Usual Care - Current Diabetes Management System (DMS)		Interventional: Accu-Chek® CONNECT DMS
Arm/Group Description	Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.		Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.
All Cause Mortality
	Control: Usual Care - Current Diabetes Management System (DMS)		Interventional: Accu-Chek® CONNECT DMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/56 (0%)
Serious Adverse Events
	Control: Usual Care - Current Diabetes Management System (DMS)		Interventional: Accu-Chek® CONNECT DMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/42 (9.5%)		2/56 (3.6%)
Gastrointestinal disorders
Vomiting	1/42 (2.4%)		0/56 (0%)
Infections and infestations
Appendicitis	0/42 (0%)		1/56 (1.8%)
Gastroenteritis viral	2/42 (4.8%)		0/56 (0%)
Metabolism and nutrition disorders
Diabetic Ketoacidosis	1/42 (2.4%)		1/56 (1.8%)
Respiratory, thoracic and mediastinal disorders
Wheezing	1/42 (2.4%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Control: Usual Care - Current Diabetes Management System (DMS)		Interventional: Accu-Chek® CONNECT DMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/42 (66.7%)		6/56 (10.7%)
Infections and infestations
Gastroenteritis viral	4/42 (9.5%)		0/56 (0%)
Upper respiratory tract infection	5/42 (11.9%)		1/56 (1.8%)
Metabolism and nutrition disorders
Hypoglycaemia	27/42 (64.3%)		5/56 (8.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.