Introducing CGM at Type 1 Diabetes Diagnosis

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).

Inclusion Criteria:

- Diagnosis of type 1 diabetes mellitus

Exclusion Criteria:

- No diagnosis of type 1 diabetes mellitus