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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Accu-Chek® CONNECT DMS
* Device: DMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control: Usual Care - Current Diabetes Management System (DMS)<br>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<br>* 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).<br>|
| Experimental: Interventional: Accu-Chek® CONNECT DMS<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Month 3 | 
| 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. | Baseline, Months 3 and 6 | 
| 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. | Baseline, Months 3 and 6 | 
| 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. | Baseline, Months 3 and 6 | 
| 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. | Baseline, Months 3 and 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 | 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. | Baseline, Months 3 and 6 | 
| 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. | Baseline, Months 3 and 6 | 
| 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. | Baseline, Months 3 and 6 | 
| 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. | Month 6 | 
| 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. | Month 6 | 
| 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. | Month 6 |