Diabetes Risk Diagnosis and Management (DIARIO)

January 11, 2022 updated by: Licia Iacoviello, Neuromed IRCCS

Early Diagnosis and Management of Patients at Risk for Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • IS
      • Pozzilli, IS, Italy, 86077
        • IRCCS INM Neuromed, Department of Epidemiology and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

34 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months
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.
18 months
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).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuromed IRCCS

Investigators

  • Principal Investigator: Licia Iacoviello, MD, PhD, IRCCS Neuromed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2019

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

May 11, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 12, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEP3_2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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