Diabetes Risk Diagnosis and Management (DIARIO)

Neuromed IRCCS

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Procedure: New Find-risk questionnaire software

Study type: Observational

Funder types: Other

Identifiers

NCT03949504

DEP3_2019

Details and patient eligibility

About

Considering the multifactorial nature of the complications of Type 2 diabetes, such as cardiovascular and neurological complications and therefore the multiplicity of risk factors that contribute to their development, it is assumed that the use of a dedicated function of the MyStar Connect software (beta version), that allows the querying of the application through specific queries (presence of risk factors) and the calculation of specific risk scores in order to extract the patients most at risk of developing such complications, can provide support to the diabetologist to optimize management of the patient at risk and complicated through, for example, a more intensive visit program and this then translates into an improvement in the parameters related to these risk factors.

Full description

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:

1. Subjects at risk with fasting blood glucose or normal glycemic load
2. Subjects with prediabetes
3. 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.

Enrollment: 1,500 patients

Sex: All

Ages: 34 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,500 participants in 2 patient groups

General population

Description:

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

Treatment:

Procedure: New Find-risk questionnaire software

Patients with type 2 Diabetes

Description:

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