Diabetes Risk Diagnosis and Management (DIARIO)
Early Diagnosis and Management of Patients at Risk for Diabetes
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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IS
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Pozzilli、IS、イタリア、86077
- IRCCS INM Neuromed, Department of Epidemiology and Prevention
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：ケースのみ
- 時間の展望：断面図
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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
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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
他の名前：
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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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of subjects at high risk for Diabetes
時間枠：12 months
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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).
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12 months
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Number of subjects with diabetes
時間枠：18 months
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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.
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18 months
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Concentration of glucose in plasma
時間枠：24 months
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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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24 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Licia Iacoviello, MD, PhD、IRCCS Neuromed
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Diabetes Care. 2010 Apr;33(4):e57.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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