Hypoglycemic EventsNCT05989256
Developing a Model to Predict Inpatient Hypoglycemic Episodes
A study testing EndoTool and glucose management team in people with Hypoglycemic Events and Hyperglycemic Therapy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study will create a new model to predict hypoglycemic events in diabetic inpatients on anti-hyperglycemic therapy using retrospective data with the goal of developing a model that will accurately predict hypoglycemic episodes in the patient population - piloting the risk score that was developed in the context of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoglycemic Events, Hyperglycemic Therapy
- What is being tested?
- EndoTool and glucose management team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Jan 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Providers taking care of adult patients (18 years and older) on the selected medical floors who are receiving anti-hyperglycemic medications on the chosen services (EndoTool and risk score implementation) and comparison groups (one group with EndoTool implementation and the other group without EndoTool implementation)
Who cannot join
- Providers not on the chosen services
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
This study will create a new model to predict hypoglycemic events in diabetic inpatients on anti-hyperglycemic therapy using retrospective data with the goal of developing a model that will accurately predict hypoglycemic episodes in the patient population - piloting the risk score that was developed in the context of EndoTool being rolled out at the institution, to determine the feasibility and acceptability of viewing the risk score in the Electronic Health Record
Read the detailed description
Design a model to predict hypoglycemic episodes in real time, rather than retrospectively identifying high risk patients who experienced a hypoglycemic event at some point during their hospitalization, as has been done prior. Potential predictors of hypoglycemia identified in prior work and additional predictors identified by the clinical team to develop a discrete-time multinomial logistic regression model to predict hypoglycemic events in real time. The risk score then will be piloted in the context of our institution's EndoTool Subcutaneous implementation determine the feasibility and acceptability of viewing the risk score in the Electronic Health Record
- Conditions
- Hypoglycemic Events, Hyperglycemic Therapy
- Being tested
- EndoTool, glucose management team, standard of care glucose management
- Keywords
- diabetes, hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoToolDiagnostic test
EndoTool is a vendor based glucose management software
glucose management teamOther
comparison group will be services that have not yet implemented EndoTool
standard of care glucose managementOther
providers adjusting insulin and consulting the Glucose Management Team at their discretion
| Study group | Role | What they receive |
|---|---|---|
| experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool | Experimental | Service where the experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool Receives: Diagnostic Test: EndoTool |
| Service where EndoTool is applied without the experimental hypoglycemia risk score | Active comparator | Service where EndoTool is applied without our experimental hypoglycemia risk score Receives: Other: glucose management team |
| Standard of care glucose management | Active comparator | Service which has not yet implemented EndoTool - providers adjusting insulin and consulting the Glucose Management Team at their discretion Receives: Other: standard of care glucose management |
What is being measured
The primary outcome is the main question the study is designed to answer.
EndoTool Utilization Rates
rate of EndoTool utilization
Measured: day 90
Glucose Monitoring Team (GMT) Consult Utilization Rates
rate of GMT utilization
Measured: day 90
Provider satisfaction scores
provider satisfaction with the alert system via survey data - 10 question survey asking Providers about their thoughts about the hypoglycemia risk score - range will be reported as their a-e answers - The provider satisfaction score ranges from 0-10 with higher scores meaning higher satisfaction.
Measured: day 90
Inpatient hypoglycemia event rates
Total number of hypoglycemic events (<70 mg/dL) that were preceded by administration of rapid/short-acting insulin within 12 hours or an anti-diabetic agent other than short-acting insulin within 24 hours, were not followed by another glucose value greater than 80 mg/dL within five minutes, and were at least 20 hours apart divided by the total number of hospital days with at least one anti-diabetic agent administered)
Measured: day 90
Secondary outcomes (1)
Number of Inpatient hospitalizations with a hyperglycemic event
Number of Inpatient hospitalizations with a hyperglycemic event within the first 10 days of the encounter minus the first 24 hours, and minus the last period before discharge if less than 24 hours. CMS defines a hyperglycemic event as a blood glucose result of >300 mg/dL, and/or a day in which a blood glucose value was not documented, and it was preceded by two consecutive days where at least one glucose value is >=200 mg/dL divided by the number of qualifying hospitalizations where the patient is 18 years or older at the start of the admission, as well as either: a diagnosis of diabetes that starts before or during the encounter; or administration of at least one dose of insulin or any hypoglycemic medication during the encounter; or presence of at least one blood glucose value >=200 mg/dL at any time during the encounter.
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study startOct 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: Lack of staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoglycemic EventsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Gorris, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989256
- Sponsor's protocol ID
- IRB00079298
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 29 Aug 2024
- 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 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Model to Predict Inpatient Hypoglycemic Episodes
- ClinicalTrials.gov ID
- NCT05989256
- Acronym / sponsor ID
- IRB00079298
- Conditions
- Hypoglycemic Events, Hyperglycemic Therapy
- Keywords
- diabetes, hypoglycemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Aug 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 will create a new model to predict hypoglycemic events in diabetic inpatients on anti-hyperglycemic therapy using retrospective data with the goal of developing a model that will accurately predict hypoglycemic episodes in the patient population - piloting the risk score that was developed in the context of EndoTool being rolled out at the institution, to determine the feasibility and acceptability of viewing the risk score in the Electronic Health Record
Detailed description
Design a model to predict hypoglycemic episodes in real time, rather than retrospectively identifying high risk patients who experienced a hypoglycemic event at some point during their hospitalization, as has been done prior. Potential predictors of hypoglycemia identified in prior work and additional predictors identified by the clinical team to develop a discrete-time multinomial logistic regression model to predict hypoglycemic events in real time. The risk score then will be piloted in the context of our institution's EndoTool Subcutaneous implementation determine the feasibility and acceptability of viewing the risk score in the Electronic Health Record
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool | Experimental | Diagnostic Test: EndoToolService where the experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool |
| Service where EndoTool is applied without the experimental hypoglycemia risk score | Active comparator | Other: glucose management teamService where EndoTool is applied without our experimental hypoglycemia risk score |
| Standard of care glucose management | Active comparator | Other: standard of care glucose managementService which has not yet implemented EndoTool - providers adjusting insulin and consulting the Glucose Management Team at their discretion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Providers taking care of adult patients (18 years and older) on the selected medical floors who are receiving anti-hyperglycemic medications on the chosen services (EndoTool and risk score implementation) and comparison groups (one group with EndoTool implementation and the other group without EndoTool implementation)
Key exclusion criteria (1 listed)
- Providers not on the chosen services
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 |
|---|---|---|
| EndoToolEndoTool is a vendor based glucose management software | Diagnostic test | experimental hypoglycemia risk score is applied on a service which has already implemented EndoTool |
| glucose management teamcomparison group will be services that have not yet implemented EndoTool | Other | Service where EndoTool is applied without the experimental hypoglycemia risk score |
| standard of care glucose managementproviders adjusting insulin and consulting the Glucose Management Team at their discretion | Other | Standard of care glucose management |
Primary outcome
EndoTool Utilization Rates
Time frame: day 90
rate of EndoTool utilization
Glucose Monitoring Team (GMT) Consult Utilization Rates
Time frame: day 90
rate of GMT utilization
Provider satisfaction scores
Time frame: day 90
provider satisfaction with the alert system via survey data - 10 question survey asking Providers about their thoughts about the hypoglycemia risk score - range will be reported as their a-e answers - The provider satisfaction score ranges from 0-10 with higher scores meaning higher satisfaction.
Inpatient hypoglycemia event rates
Time frame: day 90
Total number of hypoglycemic events (<70 mg/dL) that were preceded by administration of rapid/short-acting insulin within 12 hours or an anti-diabetic agent other than short-acting insulin within 24 hours, were not followed by another glucose value greater than 80 mg/dL within five minutes, and were at least 20 hours apart divided by the total number of hospital days with at least one anti-diabetic agent administered)
1 secondary outcome
Number of Inpatient hospitalizations with a hyperglycemic event
Time frame: day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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.
Matthew Gorris, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoTool and glucose management team in people with Hypoglycemic Events and Hyperglycemic Therapy, run by Wake Forest University Health Sciences 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Aug 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
EndoTool Utilization Rates (time frame: day 90). The study lists 4 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 29 Aug 2024; AzTrials last refreshed its copy on 2 Nov 2026.