Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients (T1DM AP)
2022年11月16日 更新者：Yale University
Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System
To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.
調査の概要
詳細な説明
The goals of this proposal are to implement a Close-Loop/Artificial Pancreas (CL/AP) system in older patients with type 1 diabetes mellitus (T1DM) in order to reverse brain metabolic adaptations and restore metabolic sensitivity, hypoglycemia awareness and appropriate hormonal counterregulatory responses (CRR).
For purposes of this study we are looking to enroll aged T1DM subjects under insulin pump treatment.
研究の種類
介入
入学 (実際)
7
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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Connecticut
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New Haven、Connecticut、アメリカ、06510
- Yale New Haven Hospital
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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
50年～75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:
- Provide signed and dated informed consent form
- Male or female
- Age 50-75 years (at least 50% over the age of 65)
- T1DM (>20 years duration)
- C-peptide undetectable
- HbA1c of < 8%
- Insulin pump therapy
- History of frequent hypoglycemia with unawareness (defined as 2 or more episodes of severe hypoglycemia within one year requiring assistance) and 2 or more glucose values < 54 mg/dL during the week of Continuous Glucose Monitoring (CGM) (iPRO monitor, Medtronic) prior to enrollment
- BMI <27 kg/m2
- Good general health as evidenced by medical history and blood screening
- Willing to comply with all study procedures and be available for the duration of the study
- Willing to fast for a limited time period on the morning of a clamp study
Exclusion Criteria:
- Significant diabetic complications (untreated proliferative retinopathy, creatinine ≥1.5 mg/dl, urinary albumin levels 300 mg/day, autonomic neuropathy, painful peripheral neuropathy)
- Significant alcohol intake and vegetarian diet since both are known to have an impact on counterregulation and brain metabolism
- Any contraindications for MRI scanning, including presence of metallic implants or claustrophobia.
- Heavy exercise on a regular basis (i.e. marathon runners)
- Known allergic reactions to components of the study product(s)
- Treatment with another investigational drug or other intervention
- Active infection including hepatitis C, hepatitis B, HIV
- Any past or current history of alcohol or substance abuse
- Psychiatric or neurological disorders under active treatment
- Baseline hemoglobin < 10.5 g/dL in females, or < 12.5 g/dL in males. Blood donation within 30 days of the study
- History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
- Co-existing cardiac, liver, and kidney disease
- Abnormal liver function tests
- Women that are on oral contraceptives, post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.
- Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：CL/AP system
To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.
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CL/AP system enabled insulin pump/CGM combination
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プラセボコンパレーター：usual care
Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.
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usual diabetic care (insulin pump therapy) along with CGM recording
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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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Brain Alternate Fuel Uptake
時間枠：Baseline to 8 - 10 weeks
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Change in brain alternate fuel uptake under hypoglycemia was measured by assessing the percent enrichment of Glutamine 4 (Gln4). Change was measured by subtracting follow up from baseline. Astrocytic glutamine C4 enrichment is a measure of brain acetate metabolism (an alternate fuel to glucose). Previous studies have shown that in people who have been exposed to frequent hypoglycemic episodes, glutamine C4 enrichment increases. Therefore, we expected a reduction in Glutamine C4 percent enrichment in the follow up NMR scans in the intervention group who avoided frequent hypoglycemic episodes through the CL/AP system. In addition, there is no specific cut off value used for Glutamine C4 enrichment, rather a change or reduction was expected and noted." |
Baseline to 8 - 10 weeks
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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 |
|---|---|---|
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Change in Cognitive Function: MOCA
時間枠：Baseline to 8-10 weeks
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The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Time to administer the MoCA is approximately 10 minutes.
The total possible score is 30 points; a score of 26 or above is considered normal.
Change was calculated by subtracting follow up from baseline.
https://www.parkinsons.va.gov/resources/MoCA-Instructions-English.pdf
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Baseline to 8-10 weeks
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Change in Cognitive Function: Trail Test A
時間枠：Baseline to 8-10 weeks
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Trail making test (TMT) A is a test of visual attention and task switching.
It provides information about visual search speed, speed of processing and executive function.
Time is measured in seconds.
The typical average time to complete the test is 29 seconds, a "deficient" performance would be >78 seconds; most people are able to complete in 90 seconds.
Change was calculated by subtracting follow up from baseline.
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Baseline to 8-10 weeks
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Change in Cognitive Function: Trail Test B
時間枠：Baseline to 8-10 weeks
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Trail making test (TMT) B is a test of visual attention and task switching.
It provides information about visual search speed, speed of processing and executive function.
Time will be measured in seconds.
The typical average time to complete the test is 75 seconds, a "deficient" performance would be >273 seconds; most people are able to complete in 180 seconds.
Change was calculated by subtracting follow up from baseline.
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Baseline to 8-10 weeks
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Change in Cognitive Function: Grooved Pegboard Test
時間枠：Baseline to 8-10 weeks
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The grooved pegboard test is a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination.
It consists of a small board of holes with randomly positioned slots.
Pegs with a key along one side must be rotated to match the hole before they can be inserted.
The task was completed using the dominant hand.
Time was measured in seconds.
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Baseline to 8-10 weeks
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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
捜査官
- 主任研究者：Raimund Herzog, MD、Yale School of Medicine Department of Endocrinology
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)
2017年11月1日
一次修了 (実際)
2019年8月28日
研究の完了 (実際)
2019年8月28日
試験登録日
最初に提出
2017年11月9日
QC基準を満たした最初の提出物
2017年11月22日
最初の投稿 (実際)
2017年11月27日
学習記録の更新
投稿された最後の更新 (実際)
2022年11月18日
QC基準を満たした最後の更新が送信されました
2022年11月16日
最終確認日
2022年11月1日
詳しくは
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