- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03949504
Diabetes Risk Diagnosis and Management (DIARIO)
Early Diagnosis and Management of Patients at Risk for Diabetes
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study aims are:
- To evaluate the percentage of subjects at risk of diabetes in the general population
- To evaluate the percentage of type 2 diabetics with and without complications in the identified population at risk
- To evaluate whether the new computer system is able to identify subjects at risk of developing complications or aggravation of complications already in progress (cardiovascular and neurological complications).
Through the IT platform made available within the framework of the project, the selected sample will be given the questionnaire to detect the risk of diabetic disease (FINDRISC adapted) and, in the case of a positive outcome, the subject at risk will be assessed with laboratory tests, to confirm or not the condition of prediabetes or diabetes. Therefore, all the subsequent phases of patient care and management will be followed, from the modification of lifestyles for prediabetics to the management of overt diabetic pathology and the complications associated with it, thus experimenting with all the modules of the software platform integrated.
Subjects who have a high diabetic risk score will be referred to the Neuromed laboratories for the analysis of fasting blood glucose and the glycemic load test. Consistent with the diagnostic protocol developed, the subjects will follow a triple address:
- Subjects at risk with fasting blood glucose or normal glycemic load
- Subjects with prediabetes
- Subjects with diabetes Patients in whom a vascular or neurological complication is diagnosed will be managed by the Neuromed clinic work groups using dedicated modules developed within the project.
At time T0 for diabetic patients without or with cardiovascular and neurological complications who will come to visit as from normal clinical practice, the presence of risk / complication parameters will be checked and risk scores will be applied to ascertain the patient's condition. The patient will then be followed as per normal clinical practice and risk parameters and the derived scores will be re-evaluated.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
IS
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Pozzilli, IS, Italie, 86077
- IRCCS INM Neuromed, Department of Epidemiology and Prevention
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Consecutive male and female subjects, over 34 years of age recruited in teh framework of the recall phase of the Moli-sani study.
Male and Female patients with type 2 diabetes without or with cardiovascular or neurological complications
La description
Inclusion Criteria:
- Signature of informed consent;
- Subjects recruited consecutively during the recall phase of the Moli-sani project.
- Patients with type 2 diabetes mellitus and vascular or neurological complications attending the IRCCS Neuromed
Exclusion Criteria:
- Inability to understand and to want
- Refusal to sign informed consent.
- Type 1 diabetes
- Gestational diabetes.
- For subjects of the general population, a previous diagnosis of diabetes.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas uniquement
- Perspectives temporelles: Transversale
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
General population
Male and Female subjects (n=1000) over 34 years of age randomly recruited from the participants to the recall phase of the Moli-sani study
|
FINDrisk: software with 12 questions to define the risk of diabetes in the general population MyStar Connect: software to guide the diagnosis and the management of diabetes and its complications
Autres noms:
|
Patients with type 2 Diabetes
Male and Female patients with type 2 diabetes (n=550) without (n=200) or with cardiovascular (n=200) or neurological (n=150) complications consecutively admitted to the IRCCS Neuromed
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of subjects at high risk for Diabetes
Délai: 12 months
|
Risk for type 2 diabetes measured by a structured questionnaires with 11 questions scoring from -1 to 27 and classified in 5 risk categories: Low risk (score>6); Low-medium risk (score 7-11); Medium-high risk (score 12-14); high risk (score 15-20); very high risk (score >20).
|
12 months
|
Number of subjects with diabetes
Délai: 18 months
|
diabetes diagnosis will be based on fasting plasma glucose (FPG)≥126 mg/dl.
The testswill be performed in a laboratory using a certified method.
Fasting is defined as no caloric intake for at least 8 h.
|
18 months
|
Concentration of glucose in plasma
Délai: 24 months
|
Glucose control in patients with diabetes and cardiovascular or neurological complications, measured with plasma glucose criteria, defined as FPG <126 mg/dL (7.0 mmol/L).
|
24 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Licia Iacoviello, MD, PhD, IRCCS Neuromed
Publications et liens utiles
Publications générales
- Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Lindstrom J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003 Mar;26(3):725-31. doi: 10.2337/diacare.26.3.725.
- Bergmann A, Li J, Wang L, Schulze J, Bornstein SR, Schwarz PE. A simplified Finnish diabetes risk score to predict type 2 diabetes risk and disease evolution in a German population. Horm Metab Res. 2007 Sep;39(9):677-82. doi: 10.1055/s-2007-985353.
- Li J, Bergmann A, Reimann M, Bornstein SR, Schwarz PE. A more simplified Finnish diabetes risk score for opportunistic screening of undiagnosed type 2 diabetes in a German population with a family history of the metabolic syndrome. Horm Metab Res. 2009 Feb;41(2):98-103. doi: 10.1055/s-0028-1087191. Epub 2008 Oct 29.
- American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2010 Jan;33 Suppl 1(Suppl 1):S62-9. doi: 10.2337/dc10-S062. No abstract available. Erratum In: Diabetes Care. 2010 Apr;33(4):e57.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DEP3_2019
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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