CGM in Patients With ED's (CGM)

Glucose Monitoring in Patients With Eating Disorders: A Pilot Study

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Avoidant Restrictive Food Intake Disorder; Anorexia Nervosa, Binge Eating/Purging Type; ARFID; Anorexia Nervosa Restricting Type
• Intervention / Treatment: Device: Continuous Glucose Monitor

Detailed Description

It is the experience of the treatment team at ACUTE Center for Eating Disorders and Severe Malnutrition that POC fingerstick testing can be inaccurate in patients when POC fingerstick testing is compared to serum glucose values. However, this has not been formally studied.

This study seeks to define the accuracy of POC fingerstick testing and CGM as compared to blood serum glucose monitoring via phlebotomy. It also seeks to better understand the frequency of hypo- and hyperglycemia in this population using continuous glucose monitoring during the first 10 days of admission. Ideally, an accurate method of monitoring glucose values in this population beside phlebotomy draws needs to be established.

Blood will be drawn shortly after participants admission to the unit as part of usual care and will continue to be drawn daily as usual care for the next 5 days. Patient blood sugar will be checked daily using POC finger sticks until hypoglycemia resolves. If patient choose to participate in this study, the investigators will do additional POC testing on days 6 and 8 POC finger sticks will be done 30-minutes post breakfast/lunch/dinner. On the same day the patient agrees to be in this study, the patient will have a Dexcom CGM placed to the back of their arm, or on another area of the body depending on the recommendation from the manufacturer (DEXCOM). Patient will wear the CGM for the full 10 days that the study is being conducted.

Patient will also be asked to complete a simple log regarding the date and time the patient received post Breakfast/lunch/dinner POC tests on days 6 and 8. The patient may ask the PSCA Patient Safety Care Attendant (PSCA) to assist patient with this task.

Data received from the Dexcom device will automatically be uploaded to the Dexcom cloud. Only the research statistician will have access to these data. Staff from Dexcom do not have access to these data.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Kristin Sterrett, MD; Phone Number: 303-602-3810; Email: Kristin.Sterrett@dhha.org

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospital Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CGM	Device: Continuous Glucose Monitor; Patients will wear a CGM device on their arm for 10 days, while receiving standard of care blood draws and finger stick sugar checks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in glucose levels	To statically analyze the similarities and differences of interstitial glucose monitoring using CGM amongst patients with AN-R vs AN-BP vs ARFID.	10 days

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Investigators: Principal Investigator: Kristin Sterrett, MD, Denver Health and Hospital Authority

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: CGM; Continuous Glucose Monitor; ACUTE
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Hyperphagia; Anorexia; Anorexia Nervosa; Bulimia; Avoidant Restrictive Food Intake Disorder
• Other Study ID Numbers: DenverHealth

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes