NCT01390636

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 26, 2015

Status Verified

August 1, 2013

Enrollment Period

Same day

First QC Date

June 29, 2011

Last Update Submit

November 25, 2015

Conditions

Type I Diabetes Mellitus Without ComplicationEating Disorder

Keywords

Continuous Glucose MonitoringType 1 Diabetes and an Eating DisorderEating Disorder Only

Outcome Measures

Primary Outcomes (1)

  • Variation in Glycemic Profiles of ED-DMT1 and ED/only

    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 Outcomes (1)

  • Impact of Dietary Intake on Glucose Profiles of ED-DMT1 and ED/only

    10 days

Study Arms (1)

ED-DMT1 and ED/only

Eating Disorder and Type 1 Diabetes and only an Eating Disorder

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Current Melrose Institute Patient

You may qualify if:

  • Admitted to the ISL unit at Melrose Institute
  • Diagnosed with an eating disorder (Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified)
  • For ED-DMT1 group: Diagnosis of an eating disorder AND diagnosis of type 1 diabetes.
  • 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.
  • If the potential participant's age is at least 18 years she must be able to provide informed consent.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melrose Institute

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Feeding and Eating DisordersDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mazze S Mazze, PhD

    International Diabetes Center at Park Nicollet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2011

First Posted

July 11, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2011

Study Completion

May 1, 2013

Last Updated

November 26, 2015

Record last verified: 2013-08

Locations

US(1)