- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03736083
Introducing CGM at Type 1 Diabetes Diagnosis
Introducing Continuous Glucose Monitoring Technology at Diagnosis in Pediatric Type 1 Diabetes: A Proof of Concept Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of type 1 diabetes mellitus
Exclusion Criteria:
- No diagnosis of type 1 diabetes mellitus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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'
|
2 weeks,3 months, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 weeks,3 months, and 12 months
|
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'
|
2 weeks,3 months, and 12 months
|
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.'
|
2 weeks,3 months, and 12 months
|
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'
|
2 weeks,3 months, and 12 months
|
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.' |
2 weeks,3 months, and 12 months
|
Change in Glycemic control measured by A1c
Time Frame: 3 and 12 months
|
Measurement of A1c
|
3 and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of flash glucose measurements at the intervention arm
Time Frame: 3 months
|
# of flash measurements provided by the freestyle reader
|
3 months
|
Number of glucose measurements of the control arm
Time Frame: 3 months
|
# of glucose readers based on there glucose meter download
|
3 months
|
Percentage of glucose sensor readings within the range of 70 to 180 mg/dl
Time Frame: 3 months
|
Data by Freestyle libre readings
|
3 months
|
Percentage of glucose sensor readings below 80 mg/dl
Time Frame: 3 months
|
Data by Freestyle libre readings
|
3 months
|
Percentage of glucose sensor readings above 180 mg/dl
Time Frame: 3 months
|
Data by Freestyle libre readings
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Hiers, MD, University of Florida
Publications and helpful links
General Publications
- Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
- Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module. Diabetes Care. 2003 Mar;26(3):631-7. doi: 10.2337/diacare.26.3.631.
- Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.
- Gonder-Frederick L, Nyer M, Shepard JA, Vajda K, Clarke W. Assessing fear of hypoglycemia in children with Type 1 diabetes and their parents. Diabetes Manag (Lond). 2011;1(6):627-639. doi: 10.2217/DMT.11.60.
- Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the Juvenile Diabetes Research Foundation continuous glucose monitoring (JDRF-CGM) trial. Diabetes Care. 2010 Jan;33(1):17-22. doi: 10.2337/dc09-1502. Epub 2009 Oct 16.
- Shapiro JB, Vesco AT, Weil LEG, Evans MA, Hood KK, Weissberg-Benchell J. Psychometric Properties of the Problem Areas in Diabetes: Teen and Parent of Teen Versions. J Pediatr Psychol. 2018 Jun 1;43(5):561-571. doi: 10.1093/jpepsy/jsx146.
- Barnard K, Thomas S, Royle P, Noyes K, Waugh N. Fear of hypoglycaemia in parents of young children with type 1 diabetes: a systematic review. BMC Pediatr. 2010 Jul 15;10:50. doi: 10.1186/1471-2431-10-50.
- Markowitz JT, Volkening LK, Butler DA, Laffel LM. Youth-Perceived Burden of Type 1 Diabetes: Problem Areas in Diabetes Survey-Pediatric Version (PAID-Peds). J Diabetes Sci Technol. 2015 Apr 24;9(5):1080-5. doi: 10.1177/1932296815583506.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201802031 -A
- OCR19017 (Other Identifier: UF ID)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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