HyperglycemiaNCT06143202
Feasibility of CGM Use in Hospitalized Youth
An observational study of Hyperglycemia, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
This study is assessing the feasibility of a continuous glucose monitor during hospital admissions in youth and young adults with hyperglycemia due to diabetes or other underlying conditions that requires frequent glucose monitoring, through patient/family and nursing staff feedback on their perspectives and usability… Read more about this study
- Who is it for?
- Ages 2 to 26 years
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Freestyle Libre 3 Continuous Glucose Monitor
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jul 2025to 14 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Youth and young adult participants will be admitted to the hospital and have hyperglycemia resulting in an endocrine consult and requiring frequent glucose monitoring. Nursing staff providing medical care for the youth and young adult participant will be invited to complete a survey on usability of the CGM in the hospital setting.
Who may be able to join
- Participants will be 2 to less than 26 years of age at the time of enrollment.
- Participants will have a diagnosis of type 1 diabetes, type 2 diabetes, diabetes/hyperglycemia due to an underlying condition (such as in cystic fibrosis, monogenic diabetes), or medication induced diabetes/hyperglycemia (such as steroid-induced hyperglycemia or PEG-asparaginase induced hyperglycemia) and would benefit clinically from close glucose monitoring during hospitalization due to fluctuations in blood glucose values.
- Participant is expected to be in the hospital for longer than 12 hours after study enrollment with a goal of 36 hours or more as determined by study investigator or trained staff.
- Participant is willing to wear the continuous glucose monitor for the duration of the hospital admission or the lifespan of a continuous glucose monitor (7-14 days).
Who cannot join
- Has had a history of a significant skin reaction to the adhesives of a continuous glucose monitor in the past or concerns that one may occur due to underlying skin conditions (ie severe eczema, uncontrolled psoriasis, etc).
- Planned MRI or surgery during the study device use (can be enrolled pre or post procedure if sufficient time for sensor wear as determined by investigator [i.e. 24-48 before planned procedure]).
- Admission to inpatient psychiatry.
- Pregnancy.
- Currently using hydroxyurea.
- A condition that the investigator determines would prevent the patient from participation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Colorado, Barbara Davis Center
Aurora, Colorado, 80045
University of California San Francisco
San Francisco, California, 94158
Stanford University
Stanford, California, 94305
About this study
Official title: Feasibility of Continuous Glucose Monitor Use In Hospitalized Youth
This study is assessing the feasibility of a continuous glucose monitor during hospital admissions in youth and young adults with hyperglycemia due to diabetes or other underlying conditions that requires frequent glucose monitoring, through patient/family and nursing staff feedback on their perspectives and usability of the system in the hospital will be assessed through surveys. In addition, retrospective glycemic comparisons between CGM data and POC will be conducted.
Read the detailed description
Youth and young adult patients admitted to the hospital for any reason, but require glucose monitoring during the hospitalization will be enrolled in this study. Participant diagnosis can include type 1 diabetes, type 2 diabetes, medication-induced diabetes, cystic fibrosis-related diabetes, or other causes of hyperglycemia that it has been determined by the hospital team requires frequent glucose monitoring, with or without insulin management.
Enrolled participants will wear a blinded continuous glucose monitor for up to 28 days (2 sensors) or until the end of their hospitalization. In addition, enrolled participants will complete a survey to assess their perspectives on the CGM wear experience and interest in future CGM use during hospitalizations. Nursing staff of the enrolled participant will also be invited to complete a survey regarding their perspectives of CGM use in the hospital setting.
- Conditions
- Hyperglycemia
- Being tested
- Freestyle Libre 3 Continuous Glucose Monitor
- Keywords
- Hyperglycemia, Continuous glucose monitors, Pediatrics, Hospital, Diabetes
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle Libre 3 Continuous Glucose MonitorDevice
Youth and young adult participants will wear a blinded Freestyle Libre 3 CGM. Data will not be available, and therefore the device will not be used to modify medical management.
| Study group | Role | What they receive |
|---|---|---|
| You and young adult patients with hyperglycemia | Any youth and young adult patient admitted to the hospital and requiring an endocrine consult for frequent glucose monitoring and hyperglycemia management Receives: Device: Freestyle Libre 3 Continuous Glucose Monitor | |
| Nursing staff | Nursing staff providing medical care for youth and young adult patients enrolled in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective glycemic CGM and point of care comparison
Glycemic data related to time in range, time hypoglycemic, time hyperglycemic and the time of first onset of hypoglycemia and hyperglycemia will be obtained by both CGM and point of care glucose values.
Measured: Duration of study, approximately 1 year from study start
Secondary outcomes (4)
Nursing staff perspectives of CGM use in the hospital
Surveys will be provided to the nursing staff associated with an enrolled patient participant to obtain qualitative perspectives on the usability of CGMs in the hospital setting
Measured: Duration of study, approximately to 1 year from study start
Patient/Family perspectives of CGM use in the hospital
Surveys will be completed by patients/family to evaluate their experience with sensor wear in the hospital, sensor insertion, and goals for glycemic monitoring while in the hospital.
Measured: Duration of study, approximately 1 year from study start
Feasibility of CGM use through assessment of discontinuation and data loss
Identify the frequency and causes of sensor discontinuation as well as information on sensor data loss.
Measured: Duration of study, approximately 1 year from study start
Health economics data
Pilot analysis of health economics data from costs related to glycemic monitoring during the hospitalization.
Measured: Duration of study, approximately 1 year from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start15 Jul 2025
- Primary completion14 Feb 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143202
- Sponsor's protocol ID
- 23-1051
- Status last verified
- Feb 2026
- First submitted
- 9 Nov 2023
- Last updated
- 3 Mar 2026
- 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Continuous Glucose Monitor Use In Hospitalized Youth
- ClinicalTrials.gov ID
- NCT06143202
- Acronym / sponsor ID
- 23-1051
- Conditions
- Hyperglycemia
- Keywords
- Hyperglycemia, Continuous glucose monitors, Pediatrics, Hospital, Diabetes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Stanford University
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 22 Nov 2023 (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.
This study is assessing the feasibility of a continuous glucose monitor during hospital admissions in youth and young adults with hyperglycemia due to diabetes or other underlying conditions that requires frequent glucose monitoring, through patient/family and nursing staff feedback on their perspectives and usability of the system in the hospital will be assessed through surveys. In addition, retrospective glycemic comparisons between CGM data and POC will be conducted.
Detailed description
Youth and young adult patients admitted to the hospital for any reason, but require glucose monitoring during the hospitalization will be enrolled in this study. Participant diagnosis can include type 1 diabetes, type 2 diabetes, medication-induced diabetes, cystic fibrosis-related diabetes, or other causes of hyperglycemia that it has been determined by the hospital team requires frequent glucose monitoring, with or without insulin management.
Enrolled participants will wear a blinded continuous glucose monitor for up to 28 days (2 sensors) or until the end of their hospitalization. In addition, enrolled participants will complete a survey to assess their perspectives on the CGM wear experience and interest in future CGM use during hospitalizations. Nursing staff of the enrolled participant will also be invited to complete a survey regarding their perspectives of CGM use in the hospital setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| You and young adult patients with hyperglycemia | – | Device: Freestyle Libre 3 Continuous Glucose MonitorAny youth and young adult patient admitted to the hospital and requiring an endocrine consult for frequent glucose monitoring and hyperglycemia management |
| Nursing staff | – | –Nursing staff providing medical care for youth and young adult patients enrolled in the study. |
Who may qualify
- Ages
- 2 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Youth and young adult participants will be admitted to the hospital and have hyperglycemia resulting in an endocrine consult and requiring frequent glucose monitoring. Nursing staff providing medical care for the youth and young adult participant will be invited to complete a survey on usability of the CGM in the hospital setting.
Key inclusion criteria (4 listed)
- Participants will be 2 to less than 26 years of age at the time of enrollment.
- Participants will have a diagnosis of type 1 diabetes, type 2 diabetes, diabetes/hyperglycemia due to an underlying condition (such as in cystic fibrosis, monogenic diabetes), or medication induced diabetes/hyperglycemia (such as steroid-induced hyperglycemia or PEG-asparaginase induced hyperglycemia) and would benefit clinically from close glucose monitoring during hospitalization due to fluctuations in blood glucose values.
- Participant is expected to be in the hospital for longer than 12 hours after study enrollment with a goal of 36 hours or more as determined by study investigator or trained staff.
- Participant is willing to wear the continuous glucose monitor for the duration of the hospital admission or the lifespan of a continuous glucose monitor (7-14 days).
Key exclusion criteria (6 listed)
- Has had a history of a significant skin reaction to the adhesives of a continuous glucose monitor in the past or concerns that one may occur due to underlying skin conditions (ie severe eczema, uncontrolled psoriasis, etc).
- Planned MRI or surgery during the study device use (can be enrolled pre or post procedure if sufficient time for sensor wear as determined by investigator [i.e. 24-48 before planned procedure]).
- Admission to inpatient psychiatry.
- Pregnancy.
- Currently using hydroxyurea.
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 |
|---|---|---|
| Freestyle Libre 3 Continuous Glucose MonitorYouth and young adult participants will wear a blinded Freestyle Libre 3 CGM. Data will not be available, and therefore the device will not be used to modify medical management. | Device | You and young adult patients with hyperglycemia |
Primary outcome
Retrospective glycemic CGM and point of care comparison
Time frame: Duration of study, approximately 1 year from study start
Glycemic data related to time in range, time hypoglycemic, time hyperglycemic and the time of first onset of hypoglycemia and hyperglycemia will be obtained by both CGM and point of care glucose values.
4 secondary outcomes
Nursing staff perspectives of CGM use in the hospital
Time frame: Duration of study, approximately to 1 year from study start
Patient/Family perspectives of CGM use in the hospital
Time frame: Duration of study, approximately 1 year from study start
Feasibility of CGM use through assessment of discontinuation and data loss
Time frame: Duration of study, approximately 1 year from study start
Health economics data
Time frame: Duration of study, approximately 1 year from study start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Hyperglycemia
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia, run by University of Colorado, Denver at 3 sites 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 4 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: enrolling by invitation, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Retrospective glycemic CGM and point of care comparison (time frame: Duration of study, approximately 1 year from study start). 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 3 Mar 2026.