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L'essai clinique NCT05135676 (TIGHT) pour Diabète sucré de type 2 est terminé. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Time in Glucose Hospital Target (TIGHT) 169 Randomisé Observationnel
Protocol Overview:
- The glucose management team (GMT) at each site will identify potentially eligible patients.
- After informed consent and confirmation of eligibility, each participant will be randomly assigned to the Standard Target or Intensive Target group.
- Glucose management in the Standard Target Group will follow the hospital's usual practice using insulin for glucose management, with a target glucose con...
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
- TIGHT
Hypoglycemia
Glycemia
Hyperglycemia
In-patient
Hospital
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifStandard Target Group Standard therapy with glucose target 140-180 mg/dL (ADA guidelines) and masked CGM | Blinded CGM A masked CGM sensor will be worn |
ExpérimentalIntensive Target Group Intensive therapy with glucose target 90-130 mg/dL with real-time CGM | real-time CGM An unmasked CGM sensor will worn |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Co-primary Outcome: CGM-measured mean glucose (superiority) | In this trial, one of the co-primary outcomes measured using CGM for up to 10 days following randomization is the mean glucose which is tested for superiority between the intensive treatment and standard treatment. | 4-10 days |
Co-primary Outcome: CGM-measured percent time <54 mg/dL (non-inferiority) | In this trial, the other co-primary outcome measured using CGM for up to 10 days following randomization is the percent time below 54 mg/dL which is tested to demonstrate non-inferiority of intensive treatment compared with standard treatment. | 4-10 days |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
CGM Metrics by daytime only (06:00 AM to 00:00 AM) | * Percent time in range 70-180 mg/dL
* Percent time in range 70-140 mg/dL
* Percent time above 180 mg/dL
* Percent time above 250 mg/dL
* Percent time below 54 mg/dL (superiority) | 4-10 days |
CGM Metrics by nighttime only (00:00 AM to 06:00 AM) | * Percent time in range 70-180 mg/dL
* Percent time in range 70-140 mg/dL
* Percent time above 180 mg/dL
* Percent time above 250 mg/dL
* Percent time below 54 mg/dL (superiority) | 4-10 days |
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
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
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.
Suspected or confirmed acute myocardial infarction or stroke as reason for hospital admission or since admission
Considered unlikely to survive hospitalization per investigator's judgment
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
For females, pregnant or breastfeeding
• A negative serum or urine pregnancy test will be required for all females of child-bearing potential.
CGM other than study CGM being used during hospitalization or planned to be used
Blood glucose >400 mg/dL at time of potential enrollment (most recent blood glucose measurement in hospital)
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
eGFR <20 mL/min or dialysis being received or planned
ALT >3X normal or current diagnosis of cirrhosis
Cystic fibrosis
Expected need for surgery requiring general anesthesia during hospitalization
• Post-surgical enrollment is permitted
Known allergy to medical grade adhesives or a skin condition that may impact CGM performance per investigator discretion
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