CGM in Patients With ED's

Anorexia Nervosa Restricting Type Clinical Trial

— CGM  

Official title:

Glucose Monitoring in Patients With Eating Disorders: A Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05603481
• Other study ID #: DenverHealth
• Status: Enrolling by invitation
• Start date: May 9, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Anorexia Nervosa Restricting Type
• Bulimia

Intervention

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.

Locations

Country	Name	City	State
United States	Denver Health and Hospital Authority	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Frequency of hypoglycemia	To better understand the frequency of hypoglycemia measured via interstitial glucose values as reported by the CGM.	10 days
Secondary	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