Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Gothenburg, Suécia
- Gothia Forum för Klinisk Forskning, Sahlgrenska Universitetssjukhuset
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Male and female subjects 18-70 years old
- Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D patients)
- Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents
- Skin phototype 1-4
Exclusion Criteria:
- For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
- > 10 cigarettes pr. day
- Participants not able to understand and read Swedish
- In investigator's opinion, participant is not able to follow instructions as specified in the protocol
- Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
- Diagnosed with reduced circulation
- Extensive skin changes, tattoos or diseases on probe application site
- Rejection by screening optical measurements
- Known allergy to medical grade alcohol
- Known allergy to adhesives
- Systemic or topical administration of glucocorticoids for the past 7 days
- Participants undergoing dialysis treatment
- Anti-coagulation or anti-platelet therapy
- Use of beta-blockers
- Medical conditions causing bleeding tendency
- Medical history or any condition that may, in the opinion of the investigator, compromise the subject's ability to participate
- Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to HIV and Hepatitis B or C.
- Participants currently enrolled in another study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Viabilidade do dispositivo
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: RSP-08
All subjects undergo the same procedures.
Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection.
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Investigational Medical Device collecting spectral Raman data from tissue
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Generation and validation of prediction models - MARD
Prazo: One year
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Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure. |
One year
|
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Generation and validation of prediction models - ISUP
Prazo: One year
|
Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure. |
One year
|
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Generation and validation of prediction models - Consensus Error Grid
Prazo: One year
|
Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Consensus Error Grid Analysis |
One year
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels
Prazo: One year
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Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. A modeling-based evaluation of the dynamics between blood glucose and tissue glucose will be conducted and serve as a secondary endpoint of the study. |
One year
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Safety evaluation: paucity of adverse events
Prazo: One year
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Safety will be evaluated in a descriptive manner by the paucity of adverse events
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One year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Per-Anders Jansson, MD, Sahlgrenska Universitetssjukhuset, Gothenburg
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- RSP-08
Plano para dados de participantes individuais (IPD)
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