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Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor

NCT01407315 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-04-20

No results posted yet for this study

Summary

Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped with the GlucoMen®Day system, over up to 100 hours observation after implantation of the microdialysis probe. Different meal/hypo procedures will be performed at the study centre.

Conditions

Interventions

DEVICE

GlucoMenDay

Subjects will receive a standardized lunch (100 g of CHO), administration of insulin will be performed by the subject based on insulin to carbohydrate ratio. An intravenous catheter will be inserted in one forearm and venous sampling will start 1 hour after lunch ingestion. Arterialized-venous blood sampling will be performed every 15 minutes for a period of two hours. Samples will be analyzed for glucose using the Super GL; concomitantly capillary measurements using the GlucoCard G Meter will be performed. This procedure can be performed on days 3-4 of monitoring; each subject randomized to Procedure A undergoes this procedure once.

DEVICE

GlucoMenDay

Subjects will receive a standard breakfast (75g CHO), the usual morning insulin dose will be post-poned. An increased dose of rapid-acting insulin analogue aiming to produce minor hypoglycaemia based on insulin to carbohydrate ratio will be injected subcutaneously. Arterialized-venous sampling will be performed every 10 minutes for a period of two hours. Samples will be analyzed for glucose using the Super GL; concomitantly, capillary measurements using the GlucoCard G Meter will be performed. This procedure will be performed on days 2 and 4 of monitoring; each subject randomized to Procedure B undergoes this procedure twice.

Sponsors & Collaborators

  • Menarini Group

    collaborator INDUSTRY

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Thomas R. Pieber, MD · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01407315 on ClinicalTrials.gov