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L'essai clinique NCT06752928 pour Diabète de type 1 est en recrutement. 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. | ||
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Université EmoryA Study Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes 100
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L'essai clinique NCT06752928 est une étude interventionnel pour Diabète de type 1. Son statut actuel est : en recrutement. L'étude a débuté le 12 mai 2025 et vise à recruter 100 participants. Dirigée par l'Université Emory, l'étude devrait être terminée d'ici le 1 octobre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 8 octobre 2025.
Résumé succinct
This study aims to compare inpatient glycemic control by measuring the percentage of time in the range of 70-180 mg/dl and the frequency of hypoglycemia between Dexcom G7 Continuous Glucose Monitoring (CGM) and Point of Care (POC) Blood Glucose Testing in poorly controlled subjects with Type 1 Diabetes Mellitus.
The main question it aims to answer is:
-Whether there is a difference between POC testing (standard of ...
Afficher plusDescription détaillée
The CDC reports that 1.6 million U.S. adults (5.7%) have type 1 diabetes (T1D), with hospitalization rates three times higher than the general population, primarily due to diabetes-related complications such as ketoacidosis and cardiovascular disease. A study at Emory University found that hospitalized T1D patients are younger, experience longer stays and more admissions, and face worse glycemic control and higher ra...Afficher plus
Titre officiel
A Randomized Controlled Trial Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes
Pathologies
Diabète de type 1Autres identifiants de l'étude
- STUDY00008724
Numéro NCT
Date de début (réel)
2025-05-12
Dernière mise à jour publiée
2025-10-08
Date de fin (estimée)
2026-10
Inscription (estimée)
100
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Continuous Glucose Monitoring
Type 1 Diabetes Mellitus
Point of Care
Type 1 Diabetes Mellitus
Point of Care
Objectif principal
Prévention
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifStandard of Care Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) with intravenous or subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG \< 400 mg/dl). Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded to the electronic medical record (EMR) system. The researc...Afficher plus | Capillary Blood glucose Testing (POC) POC glucose meters measure whole blood and convert the results to plasma glucose concentrations, which is the standardized form used in clinical practice. |
ExpérimentalDexcom CGM Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) intravenously with subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG \< 400 mg/dl). Subjects will wear a real-time Dexcom G7 CGM for up to 10 days. Insulin therapy will be titrated based on daily CGM reports, including mean glucose, glycemic excursi...Afficher plus | Dexcom G7 rtCGM The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a glucose monitoring system that continuously measures glucose in the interstitial fluid. It aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Glycemic control | The total difference in blood sugar levels between the POC testing (standard of care) group and the rtCGM group throughout the hospitalization | Through study completion (Day 10 or the length of admission) |
Clinically significant hypoglycemia <54 mg/dl | The difference between blood sugar levels in POC testing (standard of care) group and rtCGM group during hospitalization | Through study completion (Day 10 or the length of admission) |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Time above range | % time above Target Above range (TAR). Differences between the both groups will be calculated. (TAR, \>250 mg/dl) | Through study completion (Day 10 or the length of admission) |
Time below range | % time in Below Target range (TBR). Differences between the both groups will be calculated.
Differences between the both groups will be calculated. (TBR, \< 70 and 54 mg/dl) | Through study completion (Day 10 or the length of admission) |
Glycemic Variability [% Coefficient of Variation (%CV) | % coefficient of variation will be measured during the intervention phase, compared to control, as measured by CGM. | Through study completion (Day 10 or the length of admission) |
Hypoglycemic events | Number of hypoglycemia events \< 70 and 54 mg/dl | Through study completion (Day 10 or the length of admission) |
Hyperglycemic events | Number of hypoglycemia events \>250 mg/dl | Through study completion (Day 10 or the length of admission) |
Nocturnal hypoglycemia | Number of hypoglycemic events (\<70 and \<54 mg/dl) between 22:00 and 06:00 | Through study completion (Day 10 or the length of admission) |
Prolonged hypoglycemia | Number of events of Prolonged hypoglycemia \< 70 mg/dl for more than 2 hours by CGM | Through study completion (Day 10 or the length of admission) |
Hospital Complications | Hospital complications include a composite of acute kidney injury (doubling of serum creatinine \>0.5 mg/dl from baseline), cardiovascular events, infections, and death | Through study completion (Day 10 or the length of admission) |
Recurrent hypoglycemia | Number of recurrent hypoglycemic episodes (\< 70 mg/dl) | Through study completion (Day 10 or the length of admission) |
Recurrent hyperglycemia | Number of recurrent hyperglycemic episodes (\>250 mg/dl) | Through study completion (Day 10 or the length of admission) |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- Known history of T1D treated with insulin therapy (human regular or rapid-acting analogs or ultra-rapid analogs \[lispro, aspart, glulisine, fast-acting insulin aspart, insulin lispro\]), intermediate-acting (NPH and premixed formulations) or long-acting basal (glargine, detemir, degludec) formulations.
- Admission diagnosis of T1D with poorly controlled diabetes (blood glucose > 180 mg/dl, HbA1c > 7%), including diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS).
- Expected length of hospital stay > three days at the time of randomization
- Patients admitted to the ICU
- Subjects using CGM technology before admission
- Subjects with type 2 diabetes
- Treatment with systemic immunosuppressive agents
- Cystic fibrosis
- Prisoners
- Patients expected to require MRI procedures during hospitalization.
- Female subjects who are pregnant or breastfeeding at enrollment into the study.
- Subjects not willing to wear a CGM device
- Subjects with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension) and end-stage kidney disease (eGFR< 30 ml/min), or terminal illness.
- Subjects with a history of cognitive impairment, dementia, or mental condition rendering the subject unable to understand the nature and consequences of the study
Université Emory398 essais cliniques actifs à explorerDexCom, Inc.Partie responsable de l'étude
Guillermo Umpierrez, Investigateur principal, Professor, Emory University
Contact central de l'étude
Contact: Guillermo Umpierrez, MD, 404-778-1665, [email protected]
1 Centres de l'étude dans 1 pays
Georgia
Grady Memorial Hospital, Atlanta, Georgia, 30303, United States
Guillermo Umpierrez, MD, Contact, 404-778-1665, [email protected]
En recrutement