Personalized Follow-up Program in the Type 2 Diabetes Prevention (PROXIPART)
In France, the global prevalence of diabetes was estimated to 5% of the population in 2016, the type two diabetes (DT2) corresponding to 90% of cases. This number is widely underestimated because most people are untreated and undiagnosed. Due to the silent character of this disease, it is estimated that 20 à 30 % of diabetic adults have not yet been diagnosed. The conclusions, presented during the annual meeting of EASD in 2019, suggest that the precursor signs of this disease could be present until 20 years before the diagnosis.
Diabetes is a metabolic disease and people are diagnosed, in general, around 40-50 years old. The main risk factor of type II diabetes is lifestyle (rich diet, sedentary) but there is also other factors like hyperlipidemia, high blood pressure, high fasting blood sugar, stress, smoking, heredity, family history of diabetes, or gestational diabetes. This induces an increase of obesity, itself a major risk factor for type II diabetes occurrence.
From an economical aspect, chronic pathologies (including diabetes) represent 60% of health insurance expenses, even though it concerns 35% of insured persons, i.e. 20 million of patients. The average of annual reimbursement for a type 2 diabetic patient is 4890 euros. In this context, this study is the first step of thinking about a different, coordinated care approach, based on a preventive rather than curative approach.
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Aurelie LIETAER, MD
- 電話番号：33 (0)5 59 57 75 60
- メール：a.lietaer@yahoo.fr
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
説明
Inclusion Criteria:
- Person with a FINDRISC score ≥ 10 points
- Person who has given his/her express written and informed consent
Exclusion Criteria:
- Person already diagnosed with a type 2 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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：With a personalized care program
The strategy implemented is a personalized care pathway that includes participant follow-up by a nurse for 5 years with contact every 4 months for the first year, then every 6 months
|
It includes the participant follow-up by a nurse during 5 years with a contact every 4 months for the first year, then after every 6 months
|
|
介入なし：Without a personalized care program
The comparison strategy does not include any specific management.
The patient will not receive individualized management with the nurse coordinator.
|
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 |
|---|---|---|
|
Risk factors for type 2 diabetes in participants
時間枠：5 years
|
Finnish Diabetes Risk Score (FINDRISC score) : 8 items with a total score from 0 to 26 points with 0 (no risk factor) and 26 (highest risk factor)
|
5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diabetes diagnostic
時間枠：at 5 years
|
measuring fasting blood glucose
|
at 5 years
|
|
The Quality of Life
時間枠：at 5 years
|
WHO questionary : total score out of 100, 26 questions with 5 likert scale items
|
at 5 years
|
|
program compliance
時間枠：during 5 years
|
Compliance is based on all the scheduled visits, the number of visits not carried out and the time during the research will be described in each group.
|
during 5 years
|
協力者と研究者
捜査官
- 主任研究者：Aurelie LIETAER, MD、Clinique Aguilera-RGDS
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。