Introducing CGM at Type 1 Diabetes Diagnosis
- Conditions
- Type1diabetesHypoglycemia
- Interventions
- Device: Freestyle Libre Blood Glucose Monitor
- Registration Number
- NCT03736083
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Diagnosis of type 1 diabetes mellitus
- No diagnosis of type 1 diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Freestyle Libre Group Freestyle Libre Blood Glucose Monitor Freestyle Libre Group: Participants will use the Freestyle Libre flash glucose monitoring system throughout the study for 2-3 months.
- Primary Outcome Measures
Name Time Method Change in Diabetes Treatment Satisfaction Questionnaire- Parent version 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
Name Time Method Change in Pediatric Quality of Life Survey- Parent and child versions 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'
Change in Diabetes Treatment Satisfaction Questionnaire- Teen version 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
Change in Diabetes Distress Survey- Parent version 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.'Change in Glycemic control measured by A1c 3 and 12 months Measurement of A1c
Change in Problem Areas in Diabetes survey 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.'
Change in Hypoglycemia Fear Survey - Parent and Child Versions 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'