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治験 NCT03781232（対象：糖尿病、医療機器）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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Non-invasive Glucose Measurement With Raman Technology in Patients With Type 1 and Type 2 Diabetes 47 非侵襲
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT03781232 は 介入研究 臨床試験 で、糖尿病、医療機器 を対象とした研究でした。現在は 完了 です。2018年11月22日 に開始し、47 名の参加者 が参加しました。この試験は RSP Systems A/S によって主導され、2019年8月5日 に完了しました。ClinicalTrials.gov からの最新更新日は 2019年12月4日 です。
概要
The study was established to collect data and reference measurements in order to establish calibration models for the Prototype 0.3
詳細説明
Subjects are recruited at two different sites.
Site 1: In group 1 subjects will on their regular stay in the clinic perform four measurement sessions a day. A measurement session consist of a reference capillary blood sample and two measures on the IMD.
Site 2: The study in group 2 consists of 26 home-based measurements and two in-clinic days. During the home measurements, 6 measurement sessions will be performed b...
もっと見る公式タイトル
Non-invasive Glucose Measurement With Raman Technology. Calibration of Newly Developed Devices in Patients With Type 1 and Type 2 Diabetes - Glucobrunn Study
疾患名
糖尿病医療機器その他の研究識別子
- RSP-09
NCT番号
開始日
2018-11-22
最終更新日
2019-12-04
終了予定日
2019-08-05
目標参加者数
47
試験の種類
介入研究
治験の相・段階
該当なし
状況
完了
キーワード
Non-invasive glucose monitoring
Raman spectroscopy
Raman spectroscopy
主目的
基礎研究
割付方法
非無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的RSP-09-01 Enrolled subjects will perform 4 daily measurement session during their regular stay at the clinic. A measurement session consists of a reference capillary blood sample and two measurements on the Prototype 0.3. | Prototype 0.3 Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy |
実験的RSP-09-02 Enrolled subjects will measure at home for 26 six days and visit the clinic two times. During home measurements, 6 measurement sessions will be performed by the subject a day. A measurement session consists of two BGMs, two CGMs and two measurements on the Prototype 0.3. On in-clinic visits the subject will be administered a high glucose breakfast and the following 6-7 hours, measurement sessions will be performed ev...もっと見る | Prototype 0.3 Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Generation and validation of predictive models by Inter Subject Unified Performance (ISUP). | Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels.
Models will be validated on independent data sets using the ISUP measure. | 2 years |
Generation and validation of predictive models by Mean Absolute Relative Difference (MARD) measures | Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels.
Models will be validated on independent data sets using the MARD measure. | 2 years |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- At least 18 years of age
- Have a diagnosis of type 1 or type 2 diabetes mellitus (for RSP-09-02, only patients with type 1 diabetes)
- Skin phototype 1-4
- Be willing to perform a minimum of 6 / 12 (31 during excursion days) finger sticks per day during the study
- Be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol
- Be willing to provide written signed and dated informed consent
- Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator, due to e.g. known psychiatric diagnoses, lack of cognitive ability, alcohol dependency, drug use, psychosocial overload
- Have known severe allergy to medical grade adhesive or isopropyl alcohol used to clean the skin
- Be breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control during the study execution (applicable to female subjects only)
- Unable to hold hand/arm steadily (including tremors and Parkinson's Disease)
- Severe diabetes related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
- Systemic or topical administration of glucocorticoids for the past 7 days
- Undergoing dialysis treatment
- Have extensive skin changes/diseases at the proposed measurement site (thenar) that could interfere with the accuracy of interstitial glucose measurements
- Have a concomitant medical condition which could interfere with the study devices (study arm 1: intake of acetaminophen study arm 2: intake of salicylic acid or higher doses of ascorbic acid)
- Unsuitable for participation due to any other cause as determined by the Investigator. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation e.g. with required documentation
- Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families)
Additional exclusion criteria for study arm 2:
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- Hypoglycemia unawareness
RSP Systems A/S連絡先情報がありません。
2 1カ国の場所
m&i-Fachklinik Bad Heilbrunn - Zentrum für Diabetes und Stoffwechselerkrankungen, Bad Heilbrunn, 83670, Germany
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, 89081, Germany