Type 1 Diabetes and Eating Disorder Diurnal Glucose Patterns

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Eating Disorder, Type I Diabetes Mellitus Without Complication

Participation Criteria
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Eligibility Criteria
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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) 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. 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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ED-DMT1 and ED/only<br>Eating Disorder and Type 1 Diabetes and only an Eating Disorder | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Glucose Monitoring, Type 1 Diabetes and an Eating Disorder, Eating Disorder Only