Clinical trial NCT02734667: Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
Official title: Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2016-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope to learn about how continuous glucose monitoring affects glycemic variables and diabetes-related distress.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time Spent in Blood Glucose Range (70-180mg/dL)
timeFrame: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point
measure: Glucose Monitoring Satisfaction Survey (GMSS) - Parent
timeFrame: Baseline, 24 months
measure: Time Spent in Hypoglycemia (< 70 mg/dL)
timeFrame: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point
Secondary outcomes:
measure: Pediatric Quality of Life Inventory
timeFrame: Baseline, 24 months
measure: Problem Areas in Diabetes Score
timeFrame: Baseline, 24 months
measure: Diabetes Distress Scale
timeFrame: Baseline, 24 months
measure: Patient Health Questionnaire 9
timeFrame: Baseline, 24 months
measure: State-Trait Anxiety Inventory
timeFrame: Baseline, 24 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 24 months
measure: Hypoglycemic Fear Survey
timeFrame: Baseline, 24 months
measure: Hypoglycemic Confidence Questionnaire
timeFrame: Baseline, 24 months
measure: General and Diabetes-specific Technology Use
timeFrame: Baseline, 24 months
measure: Center for Epidemiologic Studies Depression Measure
timeFrame: Baseline, 24 months
measure: Child Health Utility 9D
timeFrame: Baseline, 24 months
measure: Hemoglobin A1c
timeFrame: Baseline, 24 months
measure: C-peptide
timeFrame: Baseline, 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: Stanford University
name: Korey K Hood, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Bruce Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Paul Wadwa, MD
role: PRINCIPAL_INVESTIGATOR
References: