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Introducing CGM at Type 1 Diabetes Diagnosis

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ClinicalTrials.gov Identifier: NCT03736083
Recruitment Status : Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Diabetes Action Research and Education Foundation
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Diabetes technology is changing and has quickly become an integral part of diabetes care and management. The study team plans to study the effects of introducing technology to newly diagnosed type 1 diabetes patients. The investigators hypothesize that early access to continuous glucose monitoring (CGM) technology will potentially improve satisfaction scores, hemoglobin A1c, glycemic control, reduce hypoglycemia, and ease the burden of disease when compared to new onset patients who receive standard of care access to CGM.

Condition or disease Intervention/treatment Phase
Type1diabetes Hypoglycemia Device: Freestyle Libre Blood Glucose Monitor Not Applicable

Detailed Description:

Abstract: Diabetes technology is changing and has quickly become an integral part of diabetes care and management. Typically, patients will need to wait months due to paperwork, insurance, and logistical issues before utilizing these technologies. With this project, the investigators plan to study the effects of introducing technology to newly diagnosed type 1 diabetes patients. It is hypothesized that early access to flash continuous glucose monitoring (CGM) technology will improve scores in diabetes's measures. The primary outcome with be the parent version of the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Secondary outcomes will include other diabetes measures such as DTSQ teen version, Hypoglycemia Fear Survey (HFS)- Parent and child version, Diabetes Distress Survey (DDS)-parent version, PedsQL- parent and child versions. The study team will also look at other diabetes outcomes including A1c, time in range, and reduction in hypoglycemia.

Background: Type 1 diabetes is a complex disease requiring newly diagnosed pediatric patients and families to learn how to check blood glucoses, inject insulin, count carbohydrates, treat hypoglycemia/hyperglycemia, and perform many other complex tasks, all within the first few days after diagnosis.

Continuous glucose monitors (CGMs) and flash glucose monitors have emerged as important diabetes technologies towards providing improved care and easing the burden of disease. These technologies are most typically introduced to families in the outpatient setting 2-3 months following diagnosis due to logistical issues related to insurance coverage.

Barriers to access include requirements for insurance prior authorization, lack of immediate availability at local pharmacies, need for patient training, and the historical bias towards requiring finger stick glucose monitoring as the basis for diabetes management. Despite these barriers, the data supports the observation that CGM technology provides for better understanding of diabetes, improved quality of life for parents and children, reduced frequency of hypoglycemia, and improved A1c.

This project will potentially show the feasibility of introducing these technologies at diagnosis. New onset type 1 diabetes patients will be randomized to receive either a Freestyle Libre flash glucose monitoring system immediately at diagnosis or to delayed use of CGM (standard of care).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study team will enroll 52 consecutive new onset type 1 diabetes patients and stratify the subjects into two groups, age 4-10 vs 11-17, aiming for 26 subjects in each group. Participants will be randomized to one of the two groups using blocked randomization with random block sizes of 2 and 4, stratified by age (4-10 vs. 11-17).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Introducing Continuous Glucose Monitoring Technology at Diagnosis in Pediatric Type 1 Diabetes: A Proof of Concept Study
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Active Comparator: Freestyle Libre Group
Freestyle Libre Group: Participants will use the Freestyle Libre flash glucose monitoring system throughout the study for 2-3 months.
Device: Freestyle Libre Blood Glucose Monitor
The intervention arm of this study will begin using the Freestyle Libre glucose monitor within 2 weeks of their diabetes diagnosis

No Intervention: Control Group (standard diabetes care)
This group will receive standard care. At the around 1 week and 2 month visits, control group subjects will use a blinded Freestyle Libre Pro to provide data that can be used to compare glucose variability between groups. The Libre sensor will allow the study team to measure glucose values but the subjects will not have access to this information for management/treatment decisions and usual diabetes care will be unaffected. The Freestyle Libre Pro last 14 days, can be activated in clinic, and the sensor can be returned in person or via mail where the investigators will download the data.



Primary Outcome Measures :
  1. Change in Diabetes Treatment Satisfaction Questionnaire- Parent version [ Time Frame: 2 weeks,3 months, and 12 months ]
    Survey for Diabetes treatment satisfaction: 14 question survey with each question scaled from 0-6; with 0 being 'very dissatisfied' and 4 being 'very satisfied'


Secondary Outcome Measures :
  1. Change in Diabetes Treatment Satisfaction Questionnaire- Teen version [ Time Frame: 2 weeks,3 months, and 12 months ]
    Survey for Diabetes treatment satisfaction: 12 question survey with each question scaled from 0-6; with 0 being 'very dissatisfied' and 6 being 'very satisfied

  2. Change in Pediatric Quality of Life Survey- Parent and child versions [ Time Frame: 2 weeks,3 months, and 12 months ]
    Survey for Pediatric quality of life: 33 question survey with each question scaled from 0-4; with 0 being 'never to 4 being 'almost always'

  3. Change in Problem Areas in Diabetes survey [ Time Frame: 2 weeks,3 months, and 12 months ]
    Survey for diabetes specific distress: mean item score or 0 - 1.9 should be considered "little or no distress," a mean item score between 2.0 - 2.9 should be considered 'moderate distress,' and a mean item score > 3.0 should be considered 'high distress.'

  4. Change in Hypoglycemia Fear Survey - Parent and Child Versions [ Time Frame: 2 weeks,3 months, and 12 months ]
    Survey for fear associated with hypoglycemia: 26 question survey with each question scaled from 0-4; with 0 being 'never' and 4 being 'almost always'

  5. Change in Diabetes Distress Survey- Parent version [ Time Frame: 2 weeks,3 months, and 12 months ]

    The PARENT DDS yields a total diabetes distress score plus 4 subscale scores, each addressing a different kind of distress. To score, simply sum the patient's responses to the appropriate items and divide by the number of items in that scale.

    Current research suggests that a mean item score or 0 - 1.9 should be considered "little or no distress," a mean item score between 2.0 - 2.9 should be considered 'moderate distress,' and a mean item score > 3.0 should be considered 'high distress.'


  6. Change in Glycemic control measured by A1c [ Time Frame: 3 and 12 months ]
    Measurement of A1c


Other Outcome Measures:
  1. Number of flash glucose measurements at the intervention arm [ Time Frame: 3 months ]
    # of flash measurements provided by the freestyle reader

  2. Number of glucose measurements of the control arm [ Time Frame: 3 months ]
    # of glucose readers based on there glucose meter download

  3. Percentage of glucose sensor readings within the range of 70 to 180 mg/dl [ Time Frame: 3 months ]
    Data by Freestyle libre readings

  4. Percentage of glucose sensor readings below 80 mg/dl [ Time Frame: 3 months ]
    Data by Freestyle libre readings

  5. Percentage of glucose sensor readings above 180 mg/dl [ Time Frame: 3 months ]
    Data by Freestyle libre readings



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus

Exclusion Criteria:

  • No diagnosis of type 1 diabetes mellitus

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): NCT03736083


Locations
United States, Florida
UF Health Children's Hospital
Gainesville, Florida, United States, 32608
UF Health Pediatrics - Gerold L. Schiebler CMS Center Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Paul Hiers, MD    352-265-7337    phiers88@ufl.edu   
Contact: Michael Haller, MD    352-265-7337    hallerms@ufl.edu   
Pediatrics Endocrinology/Diabetes at UF Health Medical Plaza and Children's Medical Services Building Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Paul Hiers, MD    352-265-7337    phiers88@ufl.edu   
Contact: Michael Haller, MD    352-265-7337    hallerms@ufl.edu   
Sponsors and Collaborators
University of Florida
Diabetes Action Research and Education Foundation
Investigators
Principal Investigator: Paul Hiers, MD University of Florida

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03736083     History of Changes
Other Study ID Numbers: IRB201802031
OCR19017 ( Other Identifier: UF ID )
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 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
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Florida:
glucose monitoring
glycemic control

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