Type 1 Diabetes and Eating Disorder Diurnal Glucose Patterns

Eating Disorder Clinical Trial

— REACT5  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01390636
• Other study ID #: 04126-11-C
• Status: Terminated
• Phase: N/A
• First received: June 29, 2011
• Last updated: November 25, 2015
• Start date: July 2011
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Disease
• Eating Disorder
• Eating Disorders
• Type I Diabetes Mellitus Without Complication

Locations

Country	Name	City	State
United States	Melrose Institute	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
HealthPartners Institute	International Diabetes Center at Park Nicollet, Melrose Institute, Park Nicollet Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Impact of Dietary Intake on Glucose Profiles of ED-DMT1 and ED/only	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	No