Type 1 Diabetes and Eating Disorder Diurnal Glucose Patterns (REACT5)

November 25, 2015 updated by: HealthPartners Institute

Characterizing Diurnal Glucose Patterns of Individuals With Type 1 Diabetes and Eating Disorders

The purpose of this study is to use data from the Continuous Glucose Monitor (CGM) to determine the degree of variation in glucose levels of individuals with an eating disorder and type 1 diabetes and only an eating disorder.

Study Overview

Status

Terminated

Conditions

Detailed Description

The specific aims of the proposed research are to:

2.1 Determine the degree of variation in glycemic profiles of individuals with an Eating Disorder and Type 1 Diabetes (ED-DMT1) and an Eating Disorder only (ED/only); and

2.2 Determine the impact of nutritional intake and planned physical activity on glucose profiles of individuals with ED-DMT1 and ED/only.

These aims will be examined by characterizing:

  • glucose exposure, as measured by area under the Ambulatory Glucose Profile (AGP) median curve;
  • glucose variability, as measured by the AGP inter-quartile range; and
  • glucose stability, as measured by change in the AGP median curve.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Melrose Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Current Melrose Institute Patient

Description

Inclusion Criteria:

  • Admitted to the ISL unit at Melrose Institute

  • Diagnosed with an eating disorder (Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified)

    1. For ED-DMT1 group: Diagnosis of an eating disorder AND diagnosis of type 1 diabetes.
    2. For ED/only group: Diagnosis of an eating disorder AND no history/diagnosis of type 1 or type 2 diabetes.
  • Female.
  • At least 14 years of age.

  • Able to provide informed consent.

    1. If the potential participant's age is at least 18 years she must be able to provide informed consent.
    2. If the potential participant is less than 18 years she must have a parent or guardian able and willing to provide written informed consent on the participant's behalf. In addition, the participant must be willing to sign a consent on her own behalf.
  • Participants must be able and willing to utilize the CGM system and perform required calibrations using self-monitored blood glucose.

Exclusion Criteria:

  • Male.
  • Age < 14 years.
  • History of self-injurious behavior that the senior clinician feels precludes participation.
  • Unable to understand the study protocol.
  • Unwilling to follow the study protocol.
  • Participation in any competing research study.
  • Planned ISL admission for <4 days.
  • Pregnant.
  • Not able to communicate in English.
  • Regular use of acetaminophen or acetaminophen containing medications and not able to modify their medication to a non-acetaminophen based medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ED-DMT1 and ED/only
Eating Disorder and Type 1 Diabetes and only an Eating Disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in Glycemic Profiles of ED-DMT1 and ED/only
Time Frame: 10 days
Determine the degree of variation in glycemic profiles of individuals with ED-DMT1 and ED/only using Continuous Glucose Monitoring (CGM). CGM will be graphically and statistically represented by an Ambulatory Glucose Profile (AGP).
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Dietary Intake on Glucose Profiles of ED-DMT1 and ED/only
Time Frame: 10 days
Determine the impact of dietary intake and planned physical activity on glucose profiles of individuals with ED-DMT1 and ED/only using Continuous Glucose Monitoring (CGM). CGM will be graphically and statistically represented by an Ambulatory Glucose Profile (AGP).
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

International Diabetes Center at Park Nicollet
Park Nicollet Foundation
Melrose Institute

Investigators

  • Principal Investigator: Mazze S Mazze, PhD, International Diabetes Center At Park Nicollet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 29, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

November 26, 2015

Last Update Submitted That Met QC Criteria

November 25, 2015

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04126-11-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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