CGM in Patients With ED's

NCT05603481 | Completed FDA Device

• 1 other identifier: DenverHealth
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the accuracy of continuous glucose monitoring (CGM) with point of care (POC) fingerstick glucose monitoring and venous blood glucose in patients with eating disorders, specifically anorexia nervosa, restricting subtype (AN-R); avoidant/restrictive food intake disorder (ARFID); and anorexia nervosa, binge/purge subtype (AN-BP).

Conditions

Anorexia Nervosa Restricting Type; Anorexia Nervosa, Binge Eating/Purging Type; ARFID; Avoidant Restrictive Food Intake Disorder

Keywords

CGM; Continuous Glucose Monitor; ACUTE

Outcome Measures

Primary Outcomes (3)

• Determine the accuracy of continuous glucose monitors (CGM)

  To perform statical analysis to verify the accuracy of interstitial glucose measured via CGM as compared to the POC finger stick. In individuals with severe malnutrition, secondary to eating disorders

  10 days

• Serum glucose fluctuations

  To better understand changes in serum glucose as a function of fasting and nutritional completion as measured via interstitial glucose values as reported by the CGM.

  10 days

• Frequency of hypoglycemia

  To better understand the frequency of hypoglycemia measured via interstitial glucose values as reported by the CGM.

  10 days

Secondary Outcomes (1)

• Difference in glucose levels

  10 days

Study Arms (1)

CGM

Device: Continuous Glucose Monitor

Interventions

Continuous Glucose Monitor DEVICE

Patients will wear a CGM device on their arm for 10 days, while receiving standard of care blood draws and finger stick sugar checks.

CGM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seeking care for medically compromised severe eating-disorders. Weight less than 75% of the patient's ideal body weight (IBW). a history of serious medical complications related to the eating disorder (electrolyte imbalance, fluid problems, organ failure, cardiac irregularities or gastrointestinal complications); a need to detoxify from, or avoid complications from, a purging behavior (vomiting, laxative or diuretic abuse); and/or need for additional medical workup/oversight to determine if a presenting problem is psychiatric or medical in nature.

You may qualify if:

• Ages 18-65 and meet the DSM-V criteria for AN-R or AN-BP or ARFID
• Admission %IBW ≤ 75%

You may not qualify if:

• Diagnosed with an eating disorder other than AN-R or AN-BP or ARFID
• %IBW \> 75% on admission
• Inability to give informed consent to participate/lacks decisional capacity
• Unable to follow the study protocol
• Transferred to the unit on a mental health hold/short term certification
• Treatment team refusal of patient's participation

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Bulimia; Avoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristin Sterrett, MD

  Denver Health and Hospital Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kristin Sterrett, Hospitalist, Principal Investigator

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: November 2, 2022
• Study Start: May 9, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 2, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)