SPN-005 - A pilot study to evaluate the feasibility of a novel non-invasive technology for measuring fluctuating blood glucose levels in adults with type 1 diabetes: A single-arm pilot study
Résumé de l'étude
People with diabetes who rely on insulin therapy require frequent and/or continuous measurement of their blood glucose levels. This is important for making dosing decisions and properly adjusting blood glucose. However, the measurements are associated with skin punctures and the pain that comes with them. Therefore, there is a significant need to find a non-invasive, straightforward, and quick method for measuring blood glucose. This study investigates whether blood glucose in people with type 1 diabetes can be measured using a special light through the skin. For this purpose, the blood glucose level in 20 individuals will be planned to be lowered with insulin and glucose and then raised again while a device (Lab demo 1.0 prototype) continuously measures blood glucose through the skin.
(BASEC)
Intervention étudiée
The procedure to lower and then raise the blood glucose level will be performed once per participant and will last approximately 6-8 hours. The investigator will administer insulin via a venous catheter (access) at the beginning to lower the blood glucose in a controlled manner to a hypoglycemic state. Then, glucose will be administered via the venous catheter to raise the blood glucose again until hyperglycemia occurs. Finally, blood glucose will be stabilized at a normal level with insulin. Throughout the entire procedure, blood glucose will be measured approximately every five minutes via a venous catheter.
(BASEC)
Maladie en cours d'investigation
Type 1 diabetes
(BASEC)
Individuals who: - Are between 18 - 60 years old and have a lighter skin type - Have had type 1 diabetes for more than one year and have been using insulin for at least six months (pen or pump) - Use a continuous glucose monitor (CGM / FGM: Freestyle Libre2, Freestyle Libre3, Dexcom G6, or Dexcom G7) (BASEC)
Critères d'exclusion
Individuals who: - Have an HbA1c value above 9 percent - Have cardiovascular diseases, epilepsy, or other neurological conditions that may cause seizures - Have a changed skin condition (e.g., hyperpigmentation), skin-related complications, tattoos, or scars on the wrist that could affect the measurements (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
Liom Health AG (formerly branded as Spiden AG)
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med Markus Laimer
+41 31 632 40 70
Markus.Laimer@clutterinsel.chUniversitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM), Inselspital, Universitätsspital
(BASEC)
Informations générales
Liom Health AG,University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital
(ICTRP)
Informations scientifiques
Liom Health AG,University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
05.10.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT06097689 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
A Pilot Study to Assess the Feasibility of a Novel Non-Invasive Technology to Measure Glucose Dynamics in Adults Living with Type 1 Diabetes Mellitus: A Single-Arm Pilot Study (BASEC)
Titre académique
A Pilot Study to Assess the Feasibility of a Novel Non-Invasive Technology to Measure Glucose Dynamics in Adults Living with Type 1 Diabetes Mellitus: a Single-Arm Pilot Study (ICTRP)
Titre public
A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults with Type-1 Diabetes Mellitus (ICTRP)
Maladie en cours d'investigation
Type 1 Diabetes Mellitus;Type 1 Diabetes Mellitus with Hypoglycemia;Type 1 Diabetes Mellitus with Hyperglycemia (ICTRP)
Intervention étudiée
Device: Lab Demo 1.0 (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: 60 Years
Minimum age: 18 Years
Inclusion Criteria:
- 1.1nformed Consent signed by the subject
- 1.2 Male and female subjects 18 - 60 years of age (inclusive)
- 1.3 Skin colour Type I, II, or III according to Fitzpatrick Scale (see Appendix 1)
- 1.4 Type 1 diabetes diagnosed > 12 months ago
- 1.5 Intensified insulin therapy scheme using multiple daily injection (MDI) or
continuous subcutaneous insulin infusion (CSII) for more than 6 months
- 1.6 BMI between 18.5 and 28.0 kg/m2
- 1.7 Using a CGM/FGM system (Freestyle Libre2, Freestyle Libre3, Dexcom G6 or Dexcom
G7)
- 1.8 Willingness to follow the study procedure
Exclusion Criteria:
- 2.1 In female subjects: pregnancy or breastfeeding period (self-reported)
- 2.2 HbA1c of > 9.0% (based on last measurement by treating physician but not older
than 120 days) Note: To be repeated at the study site if measurement is older than
120 days or not available
- 2.3 History of cardiovascular diseases
- 2.4 Irregular 12-lead ECG upon investigator's judgement
- 2.5 Medical history of epilepsy or other neurological disease associated with
seizure events
- 2.6 Atypical skin condition (e.g., Hyperkeratosis, Hyperpigmentation) or presence of
tattoos or scars in the measurement area (wrist) that could impair validity of
measurement upon investigator's judgement
- 2.7 Known sensitivity to medical grade adhesives or other skin-related
complications, which might influence the outcome
- 2.8 Not able to understand, write or read German
- 2.9 Participation in another investigation with an investigational drug within the
30 days preceding and during the present investigation
- 2.10 Enrolment of the PI, his/her family members, employees and other dependent
persons (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels (ICTRP)
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels;Spectral fingerprints measured by the Lab Demo 1.0;Blood glucose levels;Heart rate;Oxygen saturation (ICTRP)
Date d'enregistrement
10.10.2023 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
DCB Research AG (ICTRP)
Contacts supplémentaires
Fabien Rebeaud, PhD;Markus Laimer, Prof Dr med, Liom Health AG,University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital (ICTRP)
ID secondaires
SPN-005 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06097689 (ICTRP)
Résultats de l'essai
Résumé des résultats
spn-005-lay-summary-v1-0.pdfLien vers les résultats dans le registre primaire
non disponible