Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes

NCT ID: NCT03020069

Last Updated: 2020-03-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-07-13

Brief Summary

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The purpose of this study is to determine that continuous glucose monitoring systems (CGMS) with intensive real time feedback about diabetes management from medical staff to the patient will affect motivation and/or behavior, in adolescents with poorly controlled type 1 diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack thereof) and patients' sense of self-efficacy will influence their stage of change and potentially glucose levels.

Detailed Description

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Sixty adolescents, ages 13-19 years, with type 1 diabetes and an HbA1c \> = 8 % who are also naive to CGMS use will be recruited from the diabetes outpatient population followed at Bellevue Hospital, Lutheran Hospital, Woodhull Hospital, and the NYU Fink Pediatric Ambulatory Care Center. Forty subjects will be randomly assigned to the CGMS group and 20 subjects will be assigned to the control group.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Glucose Meter

Continuing Glucose Monitoring Device

Group Type EXPERIMENTAL

CGMS Device

Intervention Type DEVICE

No Glucose Meter

Average Blood glucose measure

Group Type ACTIVE_COMPARATOR

No Device

Intervention Type OTHER

Interventions

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CGMS Device

Intervention Type DEVICE

No Device

Intervention Type OTHER

Other Intervention Names

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Continuing Glucose Monitoring Device

Eligibility Criteria

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Inclusion Criteria

* type 1 diabetes
* HbA1c \> = 8 %
* naive to CGMS use

Exclusion Criteria

* Patients with developmental delay
* Patients who do not use a glucose meter to test capillary blood glucose level
* Patients without access to a telephone will be excluded.
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bonita Franklin, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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New York University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-01011

Identifier Type: -

Identifier Source: org_study_id

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