Diabetes Mellitus, Type 2DIARIONCT03949504
Diabetes Risk Diagnosis and Management
An observational study of Diabetes Mellitus, Type 2, run by Neuromed IRCCS at 1 site in Italy.
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)… Read more about this study
- Who is it for?
- Ages 34 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- New Find-risk questionnaire software
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS INM Neuromed, Department of Epidemiology and Prevention
Pozzilli, IS, 86077
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- New Find-risk questionnaire software
- Keywords
- Diabetes, neurological complications, cardiovascular complications
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Find-risk questionnaire softwareProcedure or surgery
Also called MyStar Connect software (version beta)
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: New Find-risk questionnaire software | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
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.
Measured: 18 months
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).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start9 Jan 2019
- Primary completion30 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Licia Iacoviello, Neuromed IRCCS
- Investigators
- Licia iacoviello, MD, PhD, Principal investigator, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949504
- Sponsor's protocol ID
- DEP3_2019
- Acronym
- DIARIO
- Status last verified
- Jan 2022
- First submitted
- 9 May 2019
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11832527Lindstrom 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.
PubMed 12610029Bergmann 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.
PubMed 17846976Li 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.
PubMed 18975253American 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.
PubMed 20042775
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis and Management of Patients at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT03949504
- Acronym / sponsor ID
- DIARIO / DEP3_2019
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, neurological complications, cardiovascular complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General population | – | Procedure: New Find-risk questionnaire softwareMale and Female subjects (n=1000) over 34 years of age randomly recruited from the participants to the recall phase of the Moli-sani study |
| 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 |
Who may qualify
- Ages
- 34 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Find-risk questionnaire softwareAlso: MyStar Connect software (version beta)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 | Procedure or surgery | General population |
Primary outcome
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).
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Results publication: PubMed 11832527Knowler 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.
- Results publication: PubMed 12610029Lindstrom 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.
- Results publication: PubMed 17846976Bergmann 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.
- Results publication: PubMed 18975253Li 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.
- Results publication: PubMed 20042775American 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Licia iacoviello, MD, PhD principal investigator
IRCCS Neuromed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Neuromed IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects at high risk for Diabetes (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949504, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.