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NCT05135676 · ClinicalTrials.gov registry record · NA
Time in Glucose Hospital Target
A NA study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- NA
- Development phase
- 169
- Enrollment target
NCT05135676 is a NA study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 169 participants.
The verdict
NCT05135676, a NA study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 169 participants
- Enrollment target
Study Summary
Inpatient management of glycemia in people with diabetes has been inadequately studied. Previous randomized trials of intensive insulin therapy in the hospital setting resulted in excessive hypoglycemia. Current ADA guidelines (glucose 140-180 mg/dL) are by consensus with the upper bound defined by observational data and the lower bound by safety concerns. None of the previous studies of intensive glucose management used CGM technology. Whether near normal glucose levels can be achieved without increasing hypoglycemia among hospitalized patients with diabetes with the advent of CGM technology is not known. There are clear associations between hyperglycemia and poor outcomes in patients with diabetes hospitalized with infection, including COVID-19. The COVID-19 pandemic has increased the urgency to definitively answer the question of whether glucose lowering below 140-180 mg/dL can be achieved without increasing hypoglycemia. If this proposed study demonstrates intensive management of glucose to a target of 90 to 130 mg/dL without hypoglycemia is achievable in the inpatient setting with CGM technology, a larger study could then be performed to evaluate whether there is clinical benefit including a reduction in morbidity and mortality. The primary study hypothesis is that glucose management with CGM can achieve a mean glucose of 90-130 mg/dL without increasing hypoglycemia compared with standard care with a glucose target of 140-180 mg/dL. Individuals with diabetes who are hospitalized (non-ICU) for an eligible condition will be randomly assigned to receive standard therapy (glucose target 140-180 mg/dL per ADA guidelines) or intensive therapy (glucose target 90-130 mg/dL and CGM used for monitoring). Real-time CGM will be used in the Intensive Target Group and masked CGM will be used in the Standard Target Group. The co-primary outcomes, assessed via a hierarchical approach, include a treatment group comparison of mean glucose (superiority) followed by a non-infe
Interventions
- DEVICE Blinded CGM
- DEVICE real-time CGM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2022-05-10 |
| Est. Completion | 2024-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05135676
The ClinicalTrials.gov registry entry for NCT05135676 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Blinded CGM is the first listed.
NCT05135676 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05135676 about?
NCT05135676 is a clinical study titled "Time in Glucose Hospital Target". Inpatient management of glycemia in people with diabetes has been inadequately studied. Previous randomized trials of intensive insulin therapy in the hospital setting resulted in excessive hypoglycemia. Current ADA guidelines (glucose 140-180 mg/dL) are by consensus with the upper bound defined by ...
What is the current status of trial NCT05135676?
This trial is currently completed. It is a NA study. The enrollment target is 169 participants. The study started on 2022-05-10. Estimated completion is 2024-03-01.
What interventions are being tested in trial NCT05135676?
The interventions under investigation include: Blinded CGM (DEVICE), real-time CGM (DEVICE).
Who is sponsoring clinical trial NCT05135676?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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