Clinical trial NCT01390636: Type 1 Diabetes and Eating Disorder Diurnal Glucose Patterns
Official title: Characterizing Diurnal Glucose Patterns of Individuals With Type 1 Diabetes and Eating Disorders
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type I Diabetes Mellitus Without Complication
Eating Disorder
Keywords: Continuous Glucose Monitoring
Type 1 Diabetes and an Eating Disorder
Eating Disorder Only
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Park Nicollet Foundation
name: Melrose Institute
name: International Diabetes Center at Park Nicollet
First posted: 2011-07-11
Enrollment: 1
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current Melrose Institute Patient

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Variation in Glycemic Profiles of ED-DMT1 and ED/only
timeFrame: 10 days
Secondary outcomes:
measure: Impact of Dietary Intake on Glucose Profiles of ED-DMT1 and ED/only
timeFrame: 10 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Melrose Institute
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Mazze S Mazze, PhD
role: PRINCIPAL_INVESTIGATOR
References: