Clinical trial NCT03949504: Diabetes Risk Diagnosis and Management
Official title: Early Diagnosis and Management of Patients at Risk for Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
neurological complications
cardiovascular complications
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 1500
Sex: ALL
Minimum age (years): 34
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility 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.

Primary outcomes:
measure: Number of subjects at high risk for Diabetes
timeFrame: 12 months
measure: Number of subjects with diabetes
timeFrame: 18 months
measure: Concentration of glucose in plasma
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS INM Neuromed, Department of Epidemiology and Prevention
state: IS
Study officials:
affiliation: IRCCS Neuromed
name: Licia iacoviello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
citation: Lindstrom J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003 Mar;26(3):725-31. doi: 10.2337/diacare.26.3.725.
citation: Bergmann A, Li J, Wang L, Schulze J, Bornstein SR, Schwarz PE. A simplified Finnish diabetes risk score to predict type 2 diabetes risk and disease evolution in a German population. Horm Metab Res. 2007 Sep;39(9):677-82. doi: 10.1055/s-2007-985353.
citation: Li J, Bergmann A, Reimann M, Bornstein SR, Schwarz PE. A more simplified Finnish diabetes risk score for opportunistic screening of undiagnosed type 2 diabetes in a German population with a family history of the metabolic syndrome. Horm Metab Res. 2009 Feb;41(2):98-103. doi: 10.1055/s-0028-1087191. Epub 2008 Oct 29.
citation: American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2010 Jan;33 Suppl 1(Suppl 1):S62-9. doi: 10.2337/dc10-S062. No abstract available.