Insulin HypoglycemiaGINGERNCT05775770
Blood Glucose Management in Intensive Care Units
An observational study of Insulin Hypoglycemia and Glucose Test Site Bleeding, run by French Society for Intensive Care at 1 site in France.
Trial summary
The investigators propose to conduct a study of practices to describe the methods of managing glycemic control in hospitalized patients in critical care. This is a prospective multicenter observational study conducted in Intensive Medicine and Resuscitation departments in France and Belgium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin Hypoglycemia, Glucose Test Site Bleeding, Hyperglycemia
- What is being tested?
- Insulin
- How many people
- 525 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2023to 12 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients admitted to intensive care or intensive care.
Who may be able to join
- Patient with hyperglycaemia requiring an insulin prescription within 48 hours of admission
- Insulin therapy started less than 12 hours before inclusion of the patient in the study
- Expected duration of hospitalization greater than or equal to 48 hours
Who cannot join
- Moribund patients
- Patients admitted for ketoacidosis or hyperosmolar coma
- Patients admitted for symptomatic hypoglycaemia
- Patient requiring insulin for serum potassium correction
- Severe acute hepatocellular insufficiency
- Age < 18 years old
- Pregnant or breastfeeding women
- Patients under legal protection measures
Trial locations and contacts
1 site in 1 country.
Laurent Poiroux contact
About this study
Official title: Survey of Practices on the Management of Glycemia in Patients Hospitalized in Intensive Care Units
The investigators propose to conduct a study of practices to describe the methods of managing glycemic control in hospitalized patients in critical care. This is a prospective multicenter observational study conducted in Intensive Medicine and Resuscitation departments in France and Belgium. The aim of this study is to carry out an inventory of the current practices of glycemia management as well as their modalities. Being one of the key points of the management, this work will have for main objective to raise the importance of the glycemic variabilities according to the methods of insulin therapies used.
- Being tested
- Insulin
- Keywords
- glucose control, insulin
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
insulin therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic variability
Study the impact of glycemic management protocols on the glycemic variability of patients hospitalized in intensive care
Measured: 48 hours
Secondary outcomes (2)
adverse outcomes
incidence of hypoglycaemia
Measured: 48 hours
Analysis of nursing workload
nurse / patient ratio
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start20 Mar 2023
- Primary completion12 Mar 2024 (estimated)
- Study completion12 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin HypoglycemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Society for Intensive Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Papazian, Study director, French Society for Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775770
- Sponsor's protocol ID
- 2022-A01304-39
- Acronym
- GINGER
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Practices on the Management of Glycemia in Patients Hospitalized in Intensive Care Units
- ClinicalTrials.gov ID
- NCT05775770
- Acronym / sponsor ID
- GINGER / 2022-A01304-39
- Keywords
- glucose control, insulin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- French Society for Intensive CareUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 12 Mar 2024 (estimated)
- Study completion
- 12 Mar 2024 (estimated)
- First posted
- 20 Mar 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.
The investigators propose to conduct a study of practices to describe the methods of managing glycemic control in hospitalized patients in critical care. This is a prospective multicenter observational study conducted in Intensive Medicine and Resuscitation departments in France and Belgium. The aim of this study is to carry out an inventory of the current practices of glycemia management as well as their modalities. Being one of the key points of the management, this work will have for main objective to raise the importance of the glycemic variabilities according to the methods of insulin therapies used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to intensive care or intensive care.
Key inclusion criteria (3 listed)
- Patient with hyperglycaemia requiring an insulin prescription within 48 hours of admission
- Insulin therapy started less than 12 hours before inclusion of the patient in the study
- Expected duration of hospitalization greater than or equal to 48 hours
Key exclusion criteria (8 listed)
- Moribund patients
- Patients admitted for ketoacidosis or hyperosmolar coma
- Patients admitted for symptomatic hypoglycaemia
- Patient requiring insulin for serum potassium correction
- Severe acute hepatocellular insufficiency
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 |
|---|---|---|
| Insulininsulin therapy | Drug | – |
Primary outcome
glycemic variability
Time frame: 48 hours
Study the impact of glycemic management protocols on the glycemic variability of patients hospitalized in intensive care
2 secondary outcomes
adverse outcomes
Time frame: 48 hours
Analysis of nursing workload
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Laurent Poiroux contact
Laurent Papazian study director
French Society for Intensive Care
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 Insulin Hypoglycemia and Glucose Test Site Bleeding, run by French Society for Intensive Care at 1 site in France.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Apr 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Goursaud (1 45 86 74 00, goursaud-s@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic variability (time frame: 48 hours). 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 6 Apr 2023.