Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04577976
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Brief Summary:
This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in pediatric patients.

Condition or disease Intervention/treatment
Diabetes Mellitus Device: SMBG

Detailed Description:
Approximately 400 subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of Adverse Events experienced during the duration of the study. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Intervention Details:
  • Device: SMBG
    Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months.


Primary Outcome Measures :
  1. Safety of the SMBG devices. The safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in a pediatric patient population will be characterized: Serious Adverse events [ Time Frame: six months ]
    Rate of Serious Adverse events associated with Hypoglycemia and Hyper glycaemia will be determined. (e.g severe hypoglycemic occurrences requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization and moderate hypoglycemia in which the patient required the assistance of another person [e.g. as a result of confusion, coma, or seizure] during the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 50% of the study population will be age 4-12 years of age.
Criteria

Inclusion Criteria:

  • Subject must be 4 - 17 years of age.
  • Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
  • Subject is currently using SMBG for managing their diabetes.
  • Subject and/or caregiver must be able to read and understand English.
  • In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
  • Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.

Exclusion Criteria:

  • Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months.
  • Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
  • Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
  • Subject is on dialysis at the time of enrollment.
  • Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
  • Subject currently is participating in another clinical trial.
  • Subject is unsuitable for participation due to any other cause as determined by the Investigator.

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): NCT04577976


Contacts
Layout table for location contacts
Contact: Mohamed Nada, PhD (510) 749 5416 mohamed.nada@abbott.com

Locations
Layout table for location information
United States, Florida
Florida Institute Recruiting
Orlando, Florida, United States, 32825
Contact: Humberto Cruz, DO         
United States, Nevada
The DOCS Recruiting
Las Vegas, Nevada, United States, 89113
Contact: Asheesh Devan, MD         
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
Layout table for investigator information
Study Director: Shridhara A Karinka, PhD Abbott Diabetes Care
Layout table for additonal information
Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT04577976    
Other Study ID Numbers: ADC-US-PMS-20194
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No