Comparison of an Artificial Pancreas Versus Threshold Low Glucose Suspend in Type 1 Diabetic Children (SHAN)
2018年6月12日 更新者：University Hospital, Montpellier
Assessment of the Efficacy on the Reduction of Nocturnal Hypoglycemia in Children With Type 1 Diabetes of a Closed-loop Insulin Therapy (Artificial Pancreas) Compared to Insulin Pump Therapy Combined With Continuous Glucose Monitoring With Threshold Low Glucose Suspend of Infusion in Home-like Conditions
The objective of this study is to assess the efficacy of an Artificial Pancreas system which includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold Low glucose Suspend feature.
24 Children aged from 7 to 12 will be recruted in 4 clinical centres.
After a 2 week run-in period, they will attend two investigational sessions of 65 hours in home-like settings.
During each session, the CTR algorithm or the TLGS feature will be activated, depending on the randomization.
The main endpoint is the time spent below 70mg/dL between 22:00 and 07:00.
調査の概要
状態
完了
条件
詳細な説明
The study is an open randomized control trial preceded by a run-in period and follows a cross-over design.After inclusion, the therapy will be moved to sensor augmented pump therapy with a dedicated training to continuous glucose monitoring using study system (study CGM).
During 2 to 3 weeks, the patient will use his/her usual insulin pump and the study CGM (run-in period).
At the end of this period, the patient and the relative will be admitted in a parents'house or hotel/resort nearby the hospital for 65 hours to undergo the first interventional session.
Admission will be at 17:00 Day 1.
The investigator will connect wirelessly the study pump and CGM to the study platform DiAs and remote monitoring will be activated.
Until 08:00 Day 2, insulin delivery will be managed in open-loop mode, i.e. insulin doses will be decided according to capillary glucose measurements.
From 08:00 Day 2, one algorithm will be activated according to the randomization order, i.e. either the threshold low glucose suspend (TLGS) algorithm (threshold will be set at 70 mg/dl) or the closed-loop algorithm.
Insulin delivery will then be managed in open-loop mode with activated TLGS or by the closed-loop algorithm until 08:00 Day 4. In both cases, meals will be of free content and taken around 09:00, 13:00, 17:00 and 20:00.
Meal insulin doses will be managed according to pre-meal glucose level and CHO meal content in open-loop mode with TLGS, or according to DiAs bolus calculator suggestion in closed-loop mode.
Patient and relative will be encouraged to move in parents'house or hotel/resort and surroundings between meals.
The algorithm will be inactivated at 08:00 Day 4. The study pump will be removed and replaced by patient's usual pump.
The patient and the relative will be released at 10:00 after breakfast.
Study CGM will still be used at home for 2 to 4 weeks until the second interventional session.
This session will be similar to the first one but the alternative algorithm will be activated.
Patient will come back to pre-study insulin therapy from 08:00 Day 4 and be released at 10:00 when second session is completed.
研究の種類
介入
入学 (実際)
24
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。
研究場所
-
-
-
Angers、フランス、49000
- CHU d'Angers
-
Montpellier、フランス、34985
- CHU Montpellier - Hôpital Lapeyronie
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Paris、フランス、75019
- AP-HP, Hôpital Robert Debré
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Tours、フランス、37000
- CHU de Tours, Hôpital Clocheville
-
-
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
7年～12年 (子)
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 from 7 to 12
- Puberty status at Prader 1
- Diabetes diagnosed according to WHO criteria since more than 1 year
- Fasting plasma C-peptide level <0.2 ng/ml for a fasting blood glucose level < 180 mg/dl
- At least one positiveness for plasma antibodies against pancreatic islets: IAA, IA2, GAD, ICA or ZnT8, since diagnosis of diabetes
- Treatment of diabetes by insulin pump since more than 6 months
- HbA1c level below 8.5%
- Trained in carbohydrate counting
- Lack of any associated disease or therapy (except insulin) affecting glucose metabolism
- Willingness to follow all study procedures
- Informed consent signed by patient and parent or legally responsible party
- Patient must be affiliated or beneficiary of a social medical insurance
Exclusion Criteria:
- Unwillingness of one parent or the legally responsible party to be present during all study procedures
- Expected use of acetaminophen-containing drugs
- Any disease or therapy (except insulin) affecting glucose metabolism during previous month
- Impaired cognitive or psychological abilities which may result in defective adherence to study procedures
- Active enrollment in another clinical trial or participation in a study within 30 days or participation in previous studies resulting in a cumulated annual income which would exceed 4500 €
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：Control-to-Range algorithm and Threshold Low Glucose Suspend
On this arm, patients will realize two investigational sessions:
|
The insuline used is usual patient insuline.
There is no specific insulin for this protocol
The insuline used is usual patient insuline.
There is no specific insulin for this protocol
|
|
実験的：Threshold Low Glucose Suspend and Control-to-Range algorithm
On this arm, patients will realize two investigational sessions:
|
The insuline used is usual patient insuline.
There is no specific insulin for this protocol
The insuline used is usual patient insuline.
There is no specific insulin for this protocol
|
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 |
|---|---|
|
Time spent with blood glucose <70 mg/dl
時間枠：from 22:00 to 08:00, over two consecutive nights
|
from 22:00 to 08:00, over two consecutive nights
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Percent time spent with blood glucose <70mg/dl
時間枠：over two consecutive days (48h)
|
over two consecutive days (48h)
|
|
Percent time spent with blood glucose level in 70-180 mg/dl range
時間枠：from 22:00 to 08:00 over two consecutive nights
|
from 22:00 to 08:00 over two consecutive nights
|
|
Percent time spent with blood glucose level in 80-150 mg/dl range
時間枠：from 22:00 to 08:00 over two consecutive nights
|
from 22:00 to 08:00 over two consecutive nights
|
|
Percent time spent with blood glucose level in 70-180 mg/dl range
時間枠：over two consecutive days (48h)
|
over two consecutive days (48h)
|
|
Mean blood glucose level
時間枠：from 22:00 to 08:00, over two consecutive nights
|
from 22:00 to 08:00, over two consecutive nights
|
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Mean blood glucose level
時間枠：over two consecutive days (48h)
|
over two consecutive days (48h)
|
|
Number of needed interventions by the patients, the parents, and by the investigational team, to treat hypoglycemia
時間枠：during 65 hours of each investigational session
|
during 65 hours of each investigational session
|
|
Number of needed interventions by the patients, the parents, and by the investigational team, to fix issues related to the functioning of the insulin delivery system
時間枠：during 65 hours of each investigational session
|
during 65 hours of each investigational session
|
|
Score of the Artificial Pancreas Acceptance Questionnaire
時間枠：at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
|
at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
|
|
Score of the Hypo Fear Survey
時間枠：at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
|
at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
|
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。
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。
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 (実際)
2015年6月16日
一次修了 (実際)
2016年12月1日
研究の完了 (実際)
2016年12月1日
試験登録日
最初に提出
2015年7月8日
QC基準を満たした最初の提出物
2015年7月23日
最初の投稿 (見積もり)
2015年7月28日
学習記録の更新
投稿された最後の更新 (実際)
2018年6月14日
QC基準を満たした最後の更新が送信されました
2018年6月12日
最終確認日
2015年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 9525 (その他の識別子：CTEP)
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