DiabetesPhase 1NCT01198678
Feasibility Study to Assess the Safety and Functionality of the GluSense Continuous Glucose Monitor in Diabetic Patients
A Phase 1 study testing Boost Nutritional Supplement in people with Diabetes, run by GluSense Ltd at 1 site in Slovenia.
Trial summary
Currently marketed CGM sensors have an approved functional lifetime of up to 1 week. Pre-clinical studies have demonstrated that GluSense-LTone 2e3 sensors may be used to accurately monitor glucose levels for 30 days. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Boost Nutritional Supplement
- How many people
- 12 participants
- Where
- 1 siteSlovenia
- Study dates
- Nov 2010to Feb 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Male or female patients between 18 and 50 years of age
- Patients with type 1 diabetes mellitus.
- The ability to read, understand and sign an informed consent form. Written consent must be obtained prior to initiation of study procedures
Who cannot join
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
- Clinical significant illness that can compromise patient's health during study such as:
- Significant current heart disease
- Significant Liver or kidney disease
- HIV infection
- Hepatitis B or Hepatitis C infection
Show all 14Show fewer
- Malignancy
- Major allergic skin disease including plaster allergies
- Significant allergic disorders
- Current or recent significant skin conditions (e.g. eczema, psoriasis,).
- Presence of skin markings/ abnormalities around implantation site that will interfere with the skin assessment e.g. tattoos, piercings, birthmark, sunburn
- Current alcohol or substance use judged by the IP to potentially interfere with patient study compliance.
- Routine administration of Steroid based medications.
- Patients currently taking part in any other clinical trial using an investigational product within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study to Assess the Safety and Functionality of the GluSense-LTone 2e3 Continuous Glucose Monitor in Diabetic Patients
Currently marketed CGM sensors have an approved functional lifetime of up to 1 week. Pre-clinical studies have demonstrated that GluSense-LTone 2e3 sensors may be used to accurately monitor glucose levels for 30 days. The purpose of this study is to assess the safety and functionality of the device in human patients for consecutive 15 days.
GluSense-LTone 2e3 as long term CGM, will require less sensor replacements and calibration, meaning less patient interventions, and is therefore will be much more user friendly. Moreover, GluSense-LTone 2e3 shows potentially increased accuracy, especially in the critically important hypoglycemic range, meaning that better management of patient's condition may be attained.
Read the detailed description
GluSense-LTone 2e3 is a continuous glucose monitoring (CGM) system. It is a semi-invasive, optical fiber-based device with a lifetime of up to one month. The purpose of this study is to assess the safety, accuracy, calibration requirements and effective lifetime of the device.
- Conditions
- Diabetes
- Being tested
- Boost Nutritional Supplement
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boost Nutritional SupplementDietary supplement
Also called boost HP
Boost- Nutritional Supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate capability to follow glucose concentration changes over 15 consecutive days
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GluSense Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tadej Batellino, Prof, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198678
- Sponsor's protocol ID
- Slovenia-UMC-001
- Status last verified
- Dec 2010
- First submitted
- 8 Sep 2010
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Assess the Safety and Functionality of the GluSense-LTone 2e3 Continuous Glucose Monitor in Diabetic Patients
- ClinicalTrials.gov ID
- NCT01198678
- Acronym / sponsor ID
- Slovenia-UMC-001
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GluSense LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently marketed CGM sensors have an approved functional lifetime of up to 1 week. Pre-clinical studies have demonstrated that GluSense-LTone 2e3 sensors may be used to accurately monitor glucose levels for 30 days. The purpose of this study is to assess the safety and functionality of the device in human patients for consecutive 15 days.
GluSense-LTone 2e3 as long term CGM, will require less sensor replacements and calibration, meaning less patient interventions, and is therefore will be much more user friendly. Moreover, GluSense-LTone 2e3 shows potentially increased accuracy, especially in the critically important hypoglycemic range, meaning that better management of patient's condition may be attained.
Detailed description
GluSense-LTone 2e3 is a continuous glucose monitoring (CGM) system. It is a semi-invasive, optical fiber-based device with a lifetime of up to one month. The purpose of this study is to assess the safety, accuracy, calibration requirements and effective lifetime of the device.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Male or female patients between 18 and 50 years of age
- Patients with type 1 diabetes mellitus.
- The ability to read, understand and sign an informed consent form. Written consent must be obtained prior to initiation of study procedures
Key exclusion criteria (14 listed)
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
- Clinical significant illness that can compromise patient's health during study such as:
- Current or recent significant skin conditions (e.g. eczema, psoriasis,).
- Presence of skin markings/ abnormalities around implantation site that will interfere with the skin assessment e.g. tattoos, piercings, birthmark, sunburn
- Current alcohol or substance use judged by the IP to potentially interfere with patient study compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boost Nutritional SupplementAlso: boost HPBoost- Nutritional Supplement | Dietary supplement | – |
Primary outcome
Evaluate capability to follow glucose concentration changes over 15 consecutive days
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadej Batellino, Prof principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Boost Nutritional Supplement in people with Diabetes, run by GluSense Ltd at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate capability to follow glucose concentration changes over 15 consecutive days (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2011.