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Trial record 31 of 49 for:    diabetes type 1 AND (woman OR women OR female) AND blood glucose

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

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ClinicalTrials.gov Identifier: NCT02609633
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : December 28, 2015
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.




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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609633


Locations
United States, Arizona
Pediatric Endocrinology of Phoenix
Phoenix, Arizona, United States, 85053
United States, California
Center of Excellence in Diabetes and Endocrinology
Sacramento, California, United States, 95821
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, Florida
Nemours Childrens Hospital
Pensacola, Florida, United States, 32504
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
University of South Florida College of Medicine
Tampa, Florida, United States, 33612
United States, Georgia
Pediatric Endocrine Associates
Atlanta, Georgia, United States, 30342
United States, Idaho
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Advocate Center for Pediatric Research
Oak Lawn, Illinois, United States, 60453
United States, Indiana
Indiana University Riley
Carmel, Indiana, United States, 46032
United States, Minnesota
Childrens Hospital and Clinics of Minnesota
Saint Paul, Minnesota, United States, 55102
United States, New York
Women and Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
United States, North Carolina
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)

Documents provided by Hoffmann-La Roche:
Study Protocol  [PDF] August 27, 2015
Statistical Analysis Plan  [PDF] June 27, 2016


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02609633     History of Changes
Other Study ID Numbers: RD002489
First Posted: November 20, 2015    Key Record Dates
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases