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Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease 80

Terminé
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT03383627 a été une étude interventionnel pour Diabète, Maladies Rénales. Son statut actuel est : terminé. L'étude a commencé le 30 novembre 2017, avec un objectif de recruter 80 participants. Dirigée par Northwell Health, l'étude s'est terminée le 21 août 2018. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 6 avril 2021.
Résumé succinct
Diabetes control is often assessed by tests of glucose levels over time, such as the glycosylated hemoglobin A1c (HbA1c) and fructosamine. In the later stages of chronic kidney disease (CKD) there is limited data available on the utility of these tests. There are reasons to believe that the tests may be less accurate in this population. Continuous glucose monitoring (CGM) offers an effective method for understanding ...Afficher plus
Description détaillée
In the proposed study Investigator plan to utilize CGM in patients with late stage CKD stages 3b-5 to 1) determine accuracy of HbA1c and serum fructosamine testing as measures of glucose control in patients with Type 2 Diabetes Mellitus (T2DM), 2) Better understand test characteristics in the late stage CKD population (correlation, linear equation, slope, Y intercept, average glucose at different HbA1c levels), 3) De...Afficher plus
Titre officiel

Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease

Pathologies
DiabèteMaladies Rénales
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • 17-0531
Numéro NCT
NCT03383627
Date de début (réel)
2017-11-30
Dernière mise à jour publiée
2021-04-06
Date de fin (estimée)
2018-08-21
Inscription (estimée)
80
Type d'étude
Interventionnel
PHASE
N/A
Statut
Terminé
Mots clés
Chronic Kidney Disease
Objectif principal
Prévention
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalContinuous glucose monitoring
* If subjects meet inclusion criteria then they will return to the research site on Day 1 to place Freestyle Libre Pro device by the research staff for 14-day monitoring. * Subjects will be advised to return to the research site on Day 14 to remove the CGM device for analysis. On Day 14, blood will be drawn for HbA1c and fructosamine, The blood drawn for this research will be approximately 10-15 milliliters. * There ...Afficher plus
Surveillance continue de la glycémie
* The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The Freestyle Libre Pro device is FDA approved (PMA# P150021). Participants will use the FreeStyle Libre Pro Flash Glucose Monitoring device according to its approved use, on the back of the arm. * CGM m...Afficher plus
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Mean Glucose Concentration Measured by CGM
Mean glucose concentration (mg/dL) will be measured using measurements taken by CGM device.
14 Days
Number of Participants With Hypoglycemic Events
Hypoglycemic event will be considered when blood sugar level is \<=70 mg/dl. Detail information like time of event, number of subjects with an event, duration of event will be analyzed.
14 Days
Mean Number of Hypoglycemic Events Per Participant.
Total number of hypoglycemic events per subject will be calculated during the study period. Mean number of events per subject will be analyzed.
14 Days
Duration Hypoglycemic Events
As monitoring device measures blood glucose level numerous time, duration of hypoglycemic event will be calculated in percent time per subject based on total duration of time subject wore CGM device.
14 Days
Mean HbA1c
HbA1c collected at end of the participation.
14 Days
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Mean Serum Fructosamine Concentration
Serum fructosamine (µmol/L) collected at the end of participation.
14 Days
Determination of Serum Fructosamine
Using blood glucose information measured with continuous blood glucose monitoring device, probable level of serum fructosamine (µmol/L) will be measured for each participant and mean will be analyzed.
14 days
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 18 years and older with ability to speak and understand English
  • Established diagnosis of type 2 Diabetes Mellitus
  • Chronic Kidney Disease (stages 3b, 4 or 5, eGFR (Glomerular Filtration Rate) < 45 ml/min, and not on dialysis) documented within 3 months of enrollment

  • Type 2 Diabetes Mellitus.
  • Patient with End stage kidney disease on Dialysis.
  • Presence of Hemoglobinopathies.
  • Red blood cell transfusion in the last 12 weeks.
  • Hb < 9 g/dL documented within 3 months of enrollment - Dosing with an erythropoiesis stimulating agent is acceptable but dose must be stable for two months.
  • Use of acetaminophen on a daily basis.
  • Systemic steroid treatment in the past 12 weeks.
  • Greater than 50% dose change in diabetes medications or new diabetes medications started in the previous 8 weeks.
  • Currently pregnant.
Northwell Health logoNorthwell Health
Partie responsable de l'étude
Lubaina Presswala, Investigateur principal, Principal Investigator, Northwell Health
Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays

New York

Northwell Health (Division Endocrinology and Nephrology), Great Neck, New York, 11021, United States