Non-invasive Glucose Measurement With Raman Technology in Patients With Type 1 and Type 2 Diabetes
Non-invasive Glucose Measurement With Raman Technology. Calibration of Newly Developed Devices in Patients With Type 1 and Type 2 Diabetes - Glucobrunn Study
調査の概要
詳細な説明
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 by the subjects a day. A measurement session consists of two reference BGMs, two reference CGMs and two measurements on the device. On in-clinic visits, subjects will be administered high glucose breakfast and the following 6-7 hours, measurement sessions are performed every 15 minutes.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Bad Heilbrunn、ドイツ、83670
- m&i-Fachklinik Bad Heilbrunn - Zentrum für Diabetes und Stoffwechselerkrankungen
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Ulm、ドイツ、89081
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
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：基礎科学
- 割り当て：非ランダム化
- 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 |
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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.
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Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy
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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 every 15 minutes.
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Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy
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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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Generation and validation of predictive models by Inter Subject Unified Performance (ISUP).
時間枠：2 years
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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
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Generation and validation of predictive models by Mean Absolute Relative Difference (MARD) measures
時間枠：2 years
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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
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Guido Freckmann, Dr.、Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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