Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia (ePID-03)
2017年11月9日 更新者：Medtronic Diabetes
The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.
調査の概要
詳細な説明
This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop insulin delivery system using a subcutaneous glucose sensor and an external insulin pump and comparing it to an open-loop delivery system during aerobic exercise.
Subject participation will be for a maximum of 16 weeks including an outpatient study (up to 6 days) and two inpatient studies (one closed-loop; the other open-loop).
The closed- and open-loop visit consists of approximately 67 hours over 4 days and 3 nights.
研究の種類
介入
入学 (実際)
13
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
-
-
Connecticut
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New Haven、Connecticut、アメリカ、06519
- Yale Pediatrics Diabetes Research
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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
12年～30年 (子、大人)
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:
- Male and female subjects between 12-30 years of age.
- Subjects must weigh at least 50 kg to accommodate phlebotomy.
- Previously diagnosed Type 1 Diabetes Mellitus
- Diabetes duration at least 1 year.
- Currently treating their diabetes with an insulin pump.
- A1C of ≤ 9.0 % at time of enrollment.
- Willing to have an intravenous (IV) line inserted for frequent blood sampling and infusion of glucose if needed.
- Willing to wear two (2) subcutaneous glucose sensors and two (2) transmitters simultaneously during closed-loop portion of the study.
- Be in good general health without other acute or chronic illnesses except treated hypothyroidism or celiac disease and asthma not requiring glucocorticoid use.
- Able to tolerate a 75-minute exercise period of moderate intensity.
- Speak and understand English.
- Subject and parent (if minor) must be able to comprehend and sign the informed consent form and other study documents.
Exclusion Criteria:
- Pregnancy (urine pregnancy test) or lactation, if female.
- Subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data.
- Subject has a cardiac pacemaker or similar device that may be sensitive to radio frequency telemetry.
Subject using any of the following medications:
- glucocorticoids
- cyclosporine
- L-asparaginase
- niacin
- protease inhibitors
- anti-psychotics
- GnRH agonists
- beta-blockers
- calcium channel blockers
- immunosuppressants
- over-the-counter medications that may effect glucose metabolism.
Subject has any of the following conditions
- insulin allergy
- severe insulin resistance
- exercise-induced asthma
- musculoskeletal problems that may impact ability to complete exercise protocol
- substance abuse
- skin ulcers or poor wound healing
- bleeding disorders
- chronic infections
- eating disorders
- give a history of or are predisposed to major stress
- any other major organ system disease.
- Subject has experienced two (2) or more severe hypoglycemic events -seizures/coma requiring assistance in the past six (6) months.
- Subject has any other condition that in the investigator's opinion warrants exclusion from the study or precludes him/her from completing the protocol.
- Subjects using dietary supplements within 14 days of study enrollment
- Subject is currently enrolled in another study.
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：他の
- 割り当て：非ランダム化
- 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 |
|---|---|
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実験的：Closed Loop (CL) Phase
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Insulin pump controlled by closed loop unit and algorithm
|
|
介入なし：Standard of Care (OL) Phase
Standard of Care (OL) Phase or Open Loop Phase
|
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 |
|---|---|---|
|
Plasma Glucose (PG) Response to Exercise
時間枠：Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
|
PG at start of exercise minus the subsequent PG nadir
|
Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
|
|
Incidence of Hypoglycemia Immediately Following Exercise
時間枠：Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
|
Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL.
Maximum tally of hypoglycemic events within any 30 minute period is 1.
|
Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
|
|
Incidence of Nocturnal Hypoglycemia Following Exercise
時間枠：Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.
|
Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL.
Maximum tally of hypoglycemic events within any 30 minute period is 1.
|
Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Peak Post-prandial Plasma Glucose (PG)
時間枠：Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
|
For each subject and study phase, the six peak PG following each of the six meals were determined.
The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.
|
Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
|
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Nadir Plasma Glucose (PG) Immediately Following Exercise
時間枠：Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
|
The PG nadir observed following the start of exercise
|
Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
|
|
Overnight Nadir Plasma Glucose (PG)
時間枠：Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
|
For each subject and study phase, the overnight nadir PG for each of two nights were determined.
The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.
|
Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
|
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Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.
時間枠：Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL.
Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
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Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
|
Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.
時間枠：Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
For each subject and study phase, the percentage of the PG curve > 180 mg/dL.
Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
|
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
|
Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.
時間枠：Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
For each subject and study phase, the percentage of the PG curve < 70 mg/dL.
Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
|
Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
|
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
捜査官
- 主任研究者：Stuart Weinzimer, MD、Yale University
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
2009年1月1日
一次修了 (実際)
2010年11月1日
研究の完了 (実際)
2010年11月1日
試験登録日
最初に提出
2009年1月26日
QC基準を満たした最初の提出物
2009年1月26日
最初の投稿 (見積もり)
2009年1月28日
学習記録の更新
投稿された最後の更新 (実際)
2017年12月12日
QC基準を満たした最後の更新が送信されました
2017年11月9日
最終確認日
2017年11月1日
詳しくは
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