Diabetes Risk Diagnosis and Management

Diabetes Mellitus, Type 2 Clinical Trial

— DIARIO  

Official title:

Early Diagnosis and Management of Patients at Risk for Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949504
• Other study ID #: DEP3_2019
• Status: Completed
• Start date: January 9, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 34 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS INM Neuromed, Department of Epidemiology and Prevention	Pozzilli	IS

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (5)

American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2010 Jan;33 Suppl 1:S62-9. doi: 10.2337/dc10-S062. Erratum in: Diabetes Care. 2010 Apr;33(4):e57. — View 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. — View 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):393-40 — View 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 Fe — View Citation

Lindström J, Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003 Mar;26(3):725-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects at high risk for Diabetes	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
Primary	Number of subjects with diabetes	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
Primary	Concentration of glucose in plasma	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