Anorexia Nervosa Restricting TypeCGMNCT05603481
CGM in Patients With ED's
An observational study of Anorexia Nervosa Restricting Type and Anorexia Nervosa, Binge Eating/Purging Type, run by Denver Health and Hospital Authority at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorexia Nervosa Restricting Type, Anorexia Nervosa, Binge Eating/Purging Type, ARFID
- What is being tested?
- Continuous Glucose Monitor
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2023to 2 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Ages 18-65 and meet the DSM-V criteria for AN-R or AN-BP or ARFID
- Admission %IBW ≤ 75%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health and Hospital Authority
Denver, Colorado, 80204
About this study
Official title: 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).
Read the 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.
- Conditions
- Anorexia Nervosa Restricting Type, Anorexia Nervosa, Binge Eating/Purging Type, ARFID, Avoidant Restrictive Food Intake Disorder
- Being tested
- Continuous Glucose Monitor
- Keywords
- CGM, Continuous Glucose Monitor, ACUTE
- Medical subject headings
- Anorexia Nervosa, Bulimia, Avoidant Restrictive Food Intake Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
Patients will wear a CGM device on their arm for 10 days, while receiving standard of care blood draws and finger stick sugar checks.
| Study group | Role | What they receive |
|---|---|---|
| CGM | Not described Receives: Device: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 10 days
Frequency of hypoglycemia
To better understand the frequency of hypoglycemia measured via interstitial glucose values as reported by the CGM.
Measured: 10 days
Secondary outcomes (1)
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start9 May 2023
- Primary completion1 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia Nervosa Restricting TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Sterrett, Denver Health and Hospital Authority
- Investigators
- Kristin Sterrett, MD, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603481
- Sponsor's protocol ID
- DenverHealth
- Acronym
- CGM
- Status last verified
- Feb 2025
- First submitted
- 29 Jul 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Monitoring in Patients With Eating Disorders: A Pilot Study
- ClinicalTrials.gov ID
- NCT05603481
- Acronym / sponsor ID
- CGM / DenverHealth
- Conditions
- Anorexia Nervosa Restricting Type, Anorexia Nervosa, Binge Eating/Purging Type, ARFID, Avoidant Restrictive Food Intake Disorder
- Keywords
- CGM, Continuous Glucose Monitor, ACUTE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM | – | Device: Continuous Glucose Monitor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Ages 18-65 and meet the DSM-V criteria for AN-R or AN-BP or ARFID
- Admission %IBW ≤ 75%
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose MonitorPatients will wear a CGM device on their arm for 10 days, while receiving standard of care blood draws and finger stick sugar checks. | Device | CGM |
Primary outcome
Determine the accuracy of continuous glucose monitors (CGM)
Time frame: 10 days
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
Serum glucose fluctuations
Time frame: 10 days
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.
Frequency of hypoglycemia
Time frame: 10 days
To better understand the frequency of hypoglycemia measured via interstitial glucose values as reported by the CGM.
1 secondary outcome
Difference in glucose levels
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Sterrett, MD principal investigator
Denver Health and Hospital Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa Restricting Type and Anorexia Nervosa, Binge Eating/Purging Type, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the accuracy of continuous glucose monitors (CGM) (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.