Diabetes Risk Diagnosis and Management (DIARIO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03949504|
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Procedure: New Find-risk questionnaire software|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||Early Diagnosis and Management of Patients at Risk for Diabetes|
|Actual Study Start Date :||January 9, 2019|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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
Procedure: New Find-risk questionnaire software
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
Other Name: MyStar Connect software (version beta)
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
- Number of subjects at high risk for Diabetes [ Time Frame: 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).
- Number of subjects with diabetes [ Time Frame: 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.
- Concentration of glucose in plasma [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949504
|Contact: Licia Licia Iacoviello, MD, PhD||0039 firstname.lastname@example.org|
|Contact: Giovanni Licia Iacoviello, MD, PhD||0039 0865929 ext email@example.com|
|IRCCS INM Neuromed, Department of Epidemiology and Prevention||Recruiting|
|Pozzilli, IS, Italy, 86077|
|Contact: Licia Iacoviello, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Licia Iacoviello, Md, PhD|
|Principal Investigator:||Licia iacoviello, MD, PhD||IRCCS Neuromed|