Hybrid Artificial Pancreas in Home Setting (AP Hybrid)
2015年11月5日 更新者：University Hospital, Montpellier
Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes
The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients
調査の概要
詳細な説明
During this study, we propose to assess an Artificial Pancreas in a group of Type 1 diabetic patients who will participate in two study periods of two-month duration with an insulin pump and a Continuous Glucose Monitoring (CGM) device.
During one of these periods, called HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.
研究の種類
介入
入学 (実際)
36
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age ≥ 18 et < 70 years old
- Having diabetes according to WHO criteria for at least 6 months, and Type 1 diabetes according to ADA criteria
- Under basal-bolus insulin therapy using an external insulin pump for at least 3 months
- BMI < 35 kg/m²
- Willing to wear a CGM device for the whole duration of the study, except during washout period, combined with the DiAs platform during the evening and night-time for 2 months
- Trained in carbohydrate counting
- HbA1c > 7.5 % and < 10%
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, stability on the medication for at least 1 month prior to study inclusion
- Willing to undergo all study procedures
- Informed consent signed
Exclusion criteria:
- Pregnancy or breast feeding, or intention to be pregnant during the study duration
- Use of a medication that significantly impacts glucose metabolism, e.g. steroids
- Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
- Patient plans to go abroad during the trial period
- Patient is expected to be out-of-home in the evening and during night time (e.g. shift-workers, etc.) more than 25% of a study period
- Patient does not hold any nearby party for assistance if needed
- Patient with severe hypoglycemia including coma, mental confusion and/or convulsions requesting IV glucose injection or glucagon injection during the last year.
- Presence of any malignant disease, unless considered as cured for more than 10 years
- History of acute cardiovascular event during the prior year
- History of diabetic keto-acidosis during the prior 6 months
- Renal insufficiency with creatinin > 150 μmol/L
- Impairment of liver status estimated from ASAT/ALAT plasma levels > 2x upper limits of normal values
- Impaired cognitive or psychological abilities which may result in defective adherence to study conditions
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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：HYBRID-OPEN
Patients are randomized on the schedule; hybrid period and after open period. During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes. |
During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
|
|
実験的：OPEN-HYBRID
Patients are randomized on the schedule: open period and after hybrid period. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes. |
During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
|
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 |
時間枠 |
|---|---|
|
Percent time spent in target range (3.9-10.0 mmol/L or 70-180 mg/dL) during each study period
時間枠：during 2 months-hybrid period and during 2 months-open period
|
during 2 months-hybrid period and during 2 months-open period
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Low Blood Glucose Index (LBGI)
時間枠：for each period of 2 month (hybrid period and open period)
|
for each period of 2 month (hybrid period and open period)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Eric ER RENARD, MD、University Hospital, Montpellier
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Renard E, Farret A, Kropff J, Bruttomesso D, Messori M, Place J, Visentin R, Calore R, Toffanin C, Di Palma F, Lanzola G, Magni P, Boscari F, Galasso S, Avogaro A, Keith-Hynes P, Kovatchev B, Del Favero S, Cobelli C, Magni L, DeVries JH; AP@home Consortium. Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home. Diabetes Care. 2016 Jul;39(7):1151-60. doi: 10.2337/dc16-0008. Epub 2016 May 5.
- Kropff J, Del Favero S, Place J, Toffanin C, Visentin R, Monaro M, Messori M, Di Palma F, Lanzola G, Farret A, Boscari F, Galasso S, Magni P, Avogaro A, Keith-Hynes P, Kovatchev BP, Bruttomesso D, Cobelli C, DeVries JH, Renard E, Magni L; AP@home consortium. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):939-47. doi: 10.1016/S2213-8587(15)00335-6. Epub 2015 Sep 30.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年5月1日
一次修了 (実際)
2015年6月1日
研究の完了 (実際)
2015年6月1日
試験登録日
最初に提出
2014年5月29日
QC基準を満たした最初の提出物
2014年5月30日
最初の投稿 (見積もり)
2014年6月2日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年11月6日
QC基準を満たした最後の更新が送信されました
2015年11月5日
最終確認日
2015年11月1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。
HYBRIDの臨床試験
-
University of OxfordUniversity of Cape Town; Mothers2Mothers完了
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Rawda Hesham Abd ElAziz募集