Diabetes Risk Diagnosis and Management

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Procedure: New Find-risk questionnaire software

• Registration Number: NCT03949504
• Lead Sponsor: Neuromed IRCCS

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-01-09
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-11
• Study First Posted: 2019-05-14
• Primary Completion: 2021-07-30
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General population	New Find-risk questionnaire software	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

Primary Outcome Measures

Name	Time	Method
Number of subjects at high risk for Diabetes	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	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	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).

Trial Locations

Locations (1)

IRCCS INM Neuromed, Department of Epidemiology and Prevention; 🇮🇹 Pozzilli, IS, Italy