Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
16 participants
INTERVENTIONAL
2016-01-31
2016-02-29
Brief Summary
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As an aid to subjects with DM1 for managing their blood glucose levels as close to normal as possible, blood glucose monitoring systems have been developed. Available blood glucose monitoring systems today require a capillary blood sample that is analysed by a glucose meter. Subjects are normally advised by health care professionals on the appropriate blood glucose monitoring regime for their condition. However, many subjects fail to measure blood glucose as often as needed to achieve good blood glucose control despite every effort from health care professionals.
Research and development of non-invasive interstitial blood glucose monitoring methods is ongoing. All attempts to develop a non-invasive continuous glucose measuring device have so far failed. Prediktor Medical AS has developed a non-invasive sensor, GlucoPred, based on the combination of several non-invasive measurement principles and multivariate analysis and dynamic models of glucose/insulin interaction. The device will be body mounted in the form of a bracelet or a watch communicating with a mobile phone or a tablet for data presentation and collection. Development of GlucoPred is now at a stage where testing of the sensor in subjects under controlled settings is required before further development can take place.
If successful, this will be a major step ahead for all patients with diabetes and markedly increase their possibility to take care of their disease on a day to day basis without the burden of frequent blood sampling or wearing an invasive device.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GlucoPred
Glucopred
Interventions
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Glucopred
Eligibility Criteria
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Inclusion Criteria
* has read and understood the informed consent documentation and is willing to participate in the investigation and willing to sign the informed consent form
* willing to participate in the investigation using one or two GlucoPred sensors for a period of 8 days
* willing to attend 2 investigational visits with duration of up to 4 hours during the investigational period
* willing to take and record up to 16 finger-stick blood samples on Day 1 and up to 8 finger-stick blood samples daily for measuring reference values for the duration of the investigation
* Uses a blood-glucose monitoring system for self-testing on a daily basis
* Willing to use the provided blood-glucose monitoring system during the investigation
* Has access to and is willing to use a computer for downloading data and charging the sensor
Exclusion Criteria
* Unfit for participation for any reason judged by the investigator
* pregnancy
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Sykehuset Ostfold
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Sven M Carlsen, md prof
Role: PRINCIPAL_INVESTIGATOR
Norwegian University of Science and Technology
Locations
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Sykehuset Østvold
Fredrikstad, , Norway
St Olavs Hospital
Trondheim, , Norway
Countries
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Other Identifiers
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PM-GPI-II-2015
Identifier Type: -
Identifier Source: org_study_id