NCT05135676Befejeződött
Time in Glucose Hospital Target
Time in Glucose Hospital Target (TIGHT) - A Randomized Clinical Trial to Evaluate the Use of CGM to Achieve a Mean Glucose Target of 90 to 130 mg/dL Without Hypoglycemia in Hospitalized Adults With Type 2 Diabetes
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 14.
Rövid összefoglaló (regiszter, angolul)
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-inferiority comparison of time <54 mg/dL measured with CGM.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 166 (tényleges)
- Első benyújtás
- 2021. okt. 21.
- Kezdés
- 2022. máj. 10.
- Elsődleges befejezés
- 2024. márc. 1.
- Fő szponzor
- Jaeb Center for Health Research
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT05135676
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 166
- 2022. máj. 10. és az elsődleges befejezés (2024. márc. 1.) között
- 6 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Treatment with systemic immunosuppressive agents such as high dose (>7.5 mg/day Prednisone equivalent) steroids or biologics that are not regimented and have been started within the last 3 months at time of enrollment or planned treatment prior to randomization.
- Diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the 6 months prior to hospital admission, at hospital admission or prior to randomization during the current hospital admission
- One or more severe hypoglycemic events within the 6 months prior to hospital admission or prior to randomization during the current admission
- Expected need for surgery requiring general anesthesia during hospitalization
- Post-surgical enrollment is permitted
Más betegség
- Suspected or confirmed acute myocardial infarction or stroke as reason for hospital admission or since admission
- Known allergy to medical grade adhesives or a skin condition that may impact CGM performance per investigator discretion
Laborértékek
- For females, pregnant or breastfeeding
- A negative serum or urine pregnancy test will be required for all females of child-bearing potential.
- Blood glucose >400 mg/dL at time of potential enrollment (most recent blood glucose measurement in hospital)
- eGFR <20 mL/min or dialysis being received or planned
- ALT >3X normal or current diagnosis of cirrhosis
Egyéb
- Inability to provide written consent
- Admission to ICU
- Patients transferred from ICU with an expected length of stay >3 days on a non-ICU floor are eligible
- Considered unlikely to survive hospitalization per investigator's judgment
- CGM other than study CGM being used during hospitalization or planned to be used
- Insulin pump being used to deliver insulin during hospitalization or planned to be used
- Use of IV insulin at time of potential enrollment
- Hypoxia (O2 saturation <90) present at time of potential enrollment
- Anasarca present at time of potential enrollment
- Use of hydroxyurea or high dose acetaminophen use of >4g daily
- Cystic fibrosis
Kiket keres a vizsgálat
- Age >= 18 years old
- Type 2 diabetes (per investigator assessment); or if not previously diagnosed as having diabetes, HbA1c>=7.0% (laboratory-measured at or since hospital admission or within prior 3-months).
- Type 1 diabetes, atypical forms of diabetes (including pancreatectomy and pancreatitis) and stress hyperglycemia alone are not eligible.
- At least 1 blood glucose measurement >180 mg/dL since admission
- Insulin already initiated since admission or planned to be initiated
- Non-critical hospitalization with expected length of stay on non-ICU floor >3 days at time of randomization
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (6)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Emory University | Atlanta | Egyesült Államok | Ismeretlen állapot |
| University of Colorado, Anschutz Inpatient Pavilion 1 and 2 | Aurora | Egyesült Államok | Ismeretlen állapot |
| Baltimore Research and Education Foundation | Baltimore | Egyesült Államok | Ismeretlen állapot |
| University of North Carolina Hospitals | Chapel Hill | Egyesült Államok | Ismeretlen állapot |
| University of Pittsburgh Medical Center | Pittsburgh | Egyesült Államok | Ismeretlen állapot |
| University of Washington Medical Center | Seattle | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.