Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration
Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration: Evaluation of a Novel Single-Port Treatment Approach in Type 1 Diabetic Patients During a 1-Day Stay in a Clinical Research Center and a 6-Day Period at Home
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The treatment of type 1 diabetes usually comprises the measurement of glucose in blood obtained by finger pricking and the administration of insulin via subcutaneous bolus injection or continuous subcutaneous infusion.
This study seeks to test a new treatment approach where glucose sensing and insulin administration are combined and performed at a single subcutaneous tissue site (single-port treatment approach). A single-port device consisting of a continuous glucose sensor and an insulin infusion cannula is inserted into the subcutaneous tissue of 10 type-1 diabetes patients and used for insulin infusion and simultaneous glucose sensing over a 7-day period. The performance of the single-port device is assessed by comparing the obtained glucose readings with those of a blood glucose meter and an additionally worn control sensor.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Styria
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Graz, Styria, L'Autriche, A-8036
- Medical University of Graz
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18 to 65 years of age, both inclusive
- Type 1 diabetes treated with Continuous Subcutaneous Insulin Infusion (CSII)
- HbA1C < 10%
- Signed informed consent before any study-related activities
Exclusion Criteria:
- Severe acute diseases
- Clinically overt diabetic complications
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- Taking of any vasoactive substances or anticoagulation medication
- Diseases of the skin which could interfere with application of the catheters and Sensors as judged by the investigator
- Pregnancy, breastfeeding, intention of becoming pregnant or not using adequate contraception.
- Increased tendency towards development of hypoglycaemia
- Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
- Concurrent participation in another study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: glucose sensing and insulin delivery
Subcutaneous insulin delivery with an insulin pump plus glucose sensing with a continuous glucose sensor placed at the site of subcutaneous insulin delivery. In parallel, capillary glucose determinations using a conventional glucose meter as well as glucose sensing in subcutaneous, insulin-unexposed tissue using a continuous glucose sensor. |
Subcutaneous insulin (100 U/ml, NovoRapid®; Novo Nordisk, Bagsvaerd, Denmark) delivery with an insulin pump (Vibe-TM; Animas Corp., West Chester, PA, USA) and an insulin infusion cannula (SOF-SET MICRO QR 6mm; Medtronic MiniMed, USA) placed at the same site as the continuous glucose sensor.
Glucose sensing with a continuous glucose sensor (Dexcom G4 Platinum Sensor; Dexcom Inc., San Diego, USA) placed at the site of subcutaneous insulin delivery.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean absolute relative difference between sensor readings and capillary glucose readings
Délai: 7 days
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Mean absolute relative differences calculated by determining the mean of the absolute value of the percentage difference between paired sensor and capillary glucose concentration
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7 days
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Thomeas R Pieber, MD, Medical University of Graz, Internal Medicine, Endocrinology and Metabolism
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Single-Port@Home-01
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