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Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study

Stanford University logo

Stanford University

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Device: Continuous Glucose Monitor
Other: Patient Reported Outcome Questionnaires

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this pilot feasibility study is to provide continued CGM access to youth with type 2 diabetes and collect descriptive data about feasibility of use of CGM in youth with type 2 diabetes ages 4 years and older. From this study the investigators hope to learn if CGM use in youth with type 2 diabetes can be tolerated and sustained with good adherence and to describe blood glucose patterns in youth with type 2 diabetes. The primary aim will be to evaluate the feasibility of CGM start and continuation in youth with T2D and describe glucose metrics and patient reported outcomes (PROs). The investigators will pilot and refine a program to test the hypothesis that CGM start and continuation in youth with T2D is feasible and then evaluate glucose metrics and PROs.

Enrollment

30 patients

Sex

All

Ages

4 to 19 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • public insurance
  • between ages 4-19.99 years inclusive
  • diagnosis of T2D (diabetes autoantibody negative) followed in the Pediatric Endocrinology clinic at Stanford Children's Health
  • HbA1C greater than 6.5% at enrollment
  • interested in starting on a continuous glucose monitor
  • have access to a mobile device that is compatible with CGM applications or willing to use CGM receiver provided

Exclusion criteria

  • non-T2D diagnosis
  • HgA1C < 6.5%
  • are not willing to wear CGM
  • have private health insurance.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Continuous Glucose Monitor
Other group
Description:
All participants will be included in this arm
Treatment:
Other: Patient Reported Outcome Questionnaires
Device: Continuous Glucose Monitor

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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