Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes

NCT ID: NCT02734667

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-02-29

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CGM at diagnosis of T1D

Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.

Group Type: EXPERIMENTAL

CGM at diagnosis of T1D

Intervention Type: DEVICE

Initiation of non-adjunctive CGM use at diagnosis of T1D

Usual Care

Participants receive usual care for T1D for 6 months post diagnosis.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CGM at diagnosis of T1D

Initiation of non-adjunctive CGM use at diagnosis of T1D

Intervention Type: DEVICE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Korey Hood

OTHER

Sponsor Role: lead

Responsible Party

Korey Hood

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Korey K Hood, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Bruce Buckingham, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Paul Wadwa, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Stanford University

Stanford, California, United States

University of Colorado

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

35990

Identifier Type: -

Identifier Source: org_study_id