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Diabetes Risk Diagnosis and Management (DIARIO)

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ClinicalTrials.gov Identifier: NCT03949504
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Licia Iacoviello, 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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Procedure: New Find-risk questionnaire software

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.


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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

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 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



Primary Outcome Measures :
  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).



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Ages Eligible for Study:   34 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949504


Contacts
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Contact: Licia Licia Iacoviello, MD, PhD 0039 0865929 licia.iacoviello@neuromed.it
Contact: Giovanni Licia Iacoviello, MD, PhD 0039 0865929 ext 660 giovanni.degaetano@neuromed.it

Locations
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Italy
IRCCS INM Neuromed, Department of Epidemiology and Prevention Recruiting
Pozzilli, IS, Italy, 86077
Contact: Licia Iacoviello, MD, PhD       licia.iacoviello@neuromed.it   
Principal Investigator: Licia Iacoviello, Md, PhD         
Sponsors and Collaborators
Neuromed IRCCS
Investigators
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Principal Investigator: Licia iacoviello, MD, PhD IRCCS Neuromed

Publications of Results:
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Responsible Party: Licia Iacoviello, MD, PhD, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT03949504     History of Changes
Other Study ID Numbers: DEP3_2019
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Licia Iacoviello, Neuromed IRCCS:
Diabetes
neurological complications
cardiovascular complications

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases