Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
2017年6月22日 更新者：Mark DeBoer, MD、University of Virginia
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.
調査の概要
詳細な説明
Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population with clear needs but unique challenges regarding the application of artificial pancreas (AP) technologies.
Young children are likely to benefit from an AP system, with current deficits in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels; however, they have undeveloped abilities to control and interact with the AP system, posing potential safety issues.
During the hours that these children are away from their parents at school and elsewhere, they lack the sophistication to operate the currently-available tools in an AP system--and may induce harm if they are allowed to do so, causing parental resistance to AP use.
Commercially-available insulin pumps have mechanisms to lock access to children to prevent inappropriate insulin-delivery.
However, the AP is more complex than an insulin pump, both in requiring more detailed setting information (that a child could adversely alter) and in providing alerts for impending low- and high-blood glucose (BG) levels (that one wouldn't want to lock out to child use).
These functions are all run via a platform on a smart phone-a device with which young children may already feel a high degree of familiarity and thus be more likely to attempt to explore and potentially change settings.
It is likely that young children will benefit the most from a system that gives them access to some AP features but provides access to other features only for their parents.
In this sense, young children require a device that is not user-centered as much as family-centered.
A redesign of the system to provide appropriate access to AP tools-in which certain users can obtain access to certain functionalities-is direly needed before children in this age range can benefit from the improvements in blood glucose (BG) control that the AP has to offer.
研究の種類
介入
入学 (実際)
12
段階
- 適用できない
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
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Virginia
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Charlottesville、Virginia、アメリカ、22903
- University of Virginia Center for Diabetes Technology
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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
5年～9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:
Clinical diagnosis of type 1 diabetes,
- The diagnosis of type 1 diabetes is based on the investigator's judgment
- C peptide levels and antibody determinations are not required
- Daily insulin therapy for ≥ 12 months
- Insulin pump therapy for ≥ 3 months
- Age ≥5 - ≤8 years old
- Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
- Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
Exclusion Criteria:
The presence of any of the following is an exclusion for the study:
- Diabetic ketoacidosis in the past month
- Hypoglycemic seizure or loss of consciousness in the past 3 months
- History of seizure disorder (except for hypoglycemic seizure)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- Cystic fibrosis
- Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- History of ongoing renal disease (other than microalbuminuria).
- Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
- Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
- Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met.
Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal insufficiency
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：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：Group A
In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel.
All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system).
Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission.
Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.
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All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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実験的：Group B
Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission.
Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission.
As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.
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All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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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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Percent of Sensor Glucose Readings Between 70-180 mg/dL
時間枠：68 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
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68 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent of Time Sensor Glucose Readings Are <70 mg/dL
時間枠：68 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
68 hours
|
|
Percent of Time Sensor Glucose Readings Are >150 mg/dL
時間枠：72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
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Percent of Time Sensor Glucose Readings Are >180 mg/dL
時間枠：68 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
68 hours
|
|
Percent of Time Sensor Glucose Readings Are >250 mg/dL
時間枠：68 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
68 hours
|
|
Percent of Time Sensor Glucose Readings Are >400 mg/dL
時間枠：72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
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Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
時間枠：72 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
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Distribution of Sensor and Meter Glucose Values (Maximum)
時間枠：72 hours
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All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
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72 hours
|
|
Distribution of Sensor and Meter Glucose Values (Minimum)
時間枠：72 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
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Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)
時間枠：72 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
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Mean BG (as Measured by CGM)
時間枠：68 hours
|
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
|
68 hours
|
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Hypoglycemia Area Under the Curve <60
時間枠：72 hours
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All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
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Hypoglycemia Area Under the Curve <70 mg/dL
時間枠：72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
|
Hyperglycemia Area Under the Curve >180
時間枠：72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
|
Hyperglycemia Area Under the Curve >250 mg/dL
時間枠：72 hours
|
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
|
72 hours
|
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Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
時間枠：68 hours
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All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.
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68 hours
|
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End of Night Blood Glucose
時間枠：72 hours
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All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.
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72 hours
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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。
スポンサー
協力者
捜査官
- 主任研究者：Mark D. DeBoer, MD、University of Virginia, Pediatrics, Endocrinology/Diabetes
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
2016年5月1日
一次修了 (実際)
2016年5月1日
研究の完了 (実際)
2016年5月1日
試験登録日
最初に提出
2016年4月15日
QC基準を満たした最初の提出物
2016年4月20日
最初の投稿 (見積もり)
2016年4月25日
学習記録の更新
投稿された最後の更新 (実際)
2017年7月24日
QC基準を満たした最後の更新が送信されました
2017年6月22日
最終確認日
2017年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 18888
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Not yet determined
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