Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes

Synopsis of study protocol

This pilot randomized clinical trial compares newly diagnosed T1D youth who are started on
CGM (the intervention group) versus those who are not (the control group). The investigators
will examine group differences over a 6-month period (Phase 1) on two sets of outcomes:
psychosocial variables and glycemic variables. After the initial comparison of intervention
to control across the first six months after diagnosis, the investigators will conduct a
longitudinal follow-up (Phase 2) of glycemic and psychosocial variables for an additional 18
months. The CGM system used in this study is the Dexcom G5 System with the Share function
(FDA Approved). An IDE was obtained to use this system in a non-adjunctive manner.
Participants will complete Phase 1 in six months. Phase 2 includes 3 more assessments
conducted every six months until participants are two years post-diagnosis.

Study Procedures

Participants will be recruited at two centers: Stanford University and the Barbara Davis
Center for Diabetes, University of Colorado. Participants will be enrolled while inpatient or
within 1 month of diagnosis. Once identified, study staff will approach potential
participants to explain the study, determine eligibility, and obtain informed consent. Once
enrolled in the study, participants will be randomized. Participants will be randomized at a
2:1 ratio, intervention to control. The investigators will also stratify by age group to
ensure equal representation of ages across groups. The age groups (in years) are 2-6, 7-11,
and 12-17. To ensure safety in the youngest group, recruitment of participants in the age 2-6
years group will not begin until the investigators have at least 2 weeks of non-adjunctive
CGM use data in at least 3 participants aged 7-17 years. Data will be reviewed by the DSMB on
these 3 participants and if deemed safe by the DSMB, the investigators will start enrolling
participants in the youngest age group.

Inclusion Criteria:

To be eligible for the study, a child must meet the following criteria:

1. Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic
criteria

2. Time since diagnosis of no longer than one month

3. Age between 2 and 17 years

4. Parental consent (and assent from the child where applicable) to participate in the
study

5. No severe medical conditions, which in the opinion of the investigators are likely to
hinder participation in this clinical trial.

To be eligible for the study, a parent must meet the following criteria:

1. Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria
outlined above

2. Age of 18.0 years or older

3. Parent comprehends written English

4. Parent understands the study protocol and signs the informed consent document

Exclusion Criteria:

The presence of any of the following is an exclusion for the study:

1. Child has a medical disorder that in the judgment of the investigator will interfere
with completion of any aspect of the protocol (e.g., pregnancy, kidney disease,
adrenal insufficiency, skin condition that may hinder sensor application).

2. Child has a neurologic disorder that in the judgment of the investigator will affect
completion of the protocol

3. Current use of oral glucocorticoids or other medications, which in the judgment of the
investigator would be a contraindication to participation in the study

4. Child is unable to completely avoid acetaminophen for duration of study