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Completed

NCT Number: NCT03949504

Diabetes Risk Diagnosis and Management

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.

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Key information

Age range

34 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS INM Neuromed, Department of Epidemiology and Prevention

Pozzilli, IS, 86077, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

New Find-risk questionnaire software

Procedure

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)

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Neuromed IRCCS

Other

Registry information

Official study title

Early Diagnosis and Management of Patients at Risk for Diabetes

Acronym: DIARIO

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 14, 2019
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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