Diabetes Mellitus, Type 1GPI-IINCT02595580
The GlucoPred Investigation II
A study testing Glucopred in people with Diabetes Mellitus, Type 1, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial summary
Diabetes mellitus type 1 (DM1) is an autoimmune metabolic disease in which the insulin producing cells in the pancreas are destroyed and the subject is left totally dependent of external supply of insulin. There is no known cure for DM1 except for in very specific situations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Glucopred
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2016to Feb 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes mellitus type 1
- 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
Who cannot join
- not fit for the investigation due concurrent illness
- Unfit for participation for any reason judged by the investigator
- pregnancy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Open, Controlled Investigation of Measurement Precision, System Accuracy and User Performance Evaluation in Subjects With Diabetes Mellitus Type 1 Using GlucoPred, a Non-invasive Continuous Blood Glucose Measurement Device
Diabetes mellitus type 1 (DM1) is an autoimmune metabolic disease in which the insulin producing cells in the pancreas are destroyed and the subject is left totally dependent of external supply of insulin. There is no known cure for DM1 except for in very specific situations. Thus, management of DM1 concentrates on keeping blood glucose levels as close to normal levels.
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.
Read more
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Glucopred
- Keywords
- Blood Glucose Self-Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucopredDevice
| Study group | Role | What they receive |
|---|---|---|
| GlucoPred | Experimental | Not described Receives: Device: Glucopred |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between Glucopred and the reference method
degree of point and trend accuracy between GlucoPred measured values and values measured by the reference methods
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: skin irritation caused by device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Sykehuset Ostfold
- Responsible party
- Sponsor
- Investigators
- Sven M Carlsen, md prof, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595580
- Sponsor's protocol ID
- PM-GPI-II-2015
- Acronym
- GPI-II
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Controlled Investigation of Measurement Precision, System Accuracy and User Performance Evaluation in Subjects With Diabetes Mellitus Type 1 Using GlucoPred, a Non-invasive Continuous Blood Glucose Measurement Device
- ClinicalTrials.gov ID
- NCT02595580
- Acronym / sponsor ID
- GPI-II / PM-GPI-II-2015
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Blood Glucose Self-Monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: skin irritation caused by device
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Sykehuset Ostfold
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Nov 2015 (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.
Diabetes mellitus type 1 (DM1) is an autoimmune metabolic disease in which the insulin producing cells in the pancreas are destroyed and the subject is left totally dependent of external supply of insulin. There is no known cure for DM1 except for in very specific situations. Thus, management of DM1 concentrates on keeping blood glucose levels as close to normal levels.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GlucoPred | Experimental | Device: Glucopred |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diabetes mellitus type 1
- 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
Key exclusion criteria (3 listed)
- not fit for the investigation due concurrent illness
- Unfit for participation for any reason judged by the investigator
- pregnancy
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 |
|---|---|---|
| Glucopred | Device | GlucoPred |
Primary outcome
difference between Glucopred and the reference method
Time frame: 8 days
degree of point and trend accuracy between GlucoPred measured values and values measured by the reference methods
Results and safety
The study was stopped early (reason given: skin irritation caused by device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
Related trials for Diabetes Mellitus, Type 1
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
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.
Sven M Carlsen, md prof principal investigator
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucopred in people with Diabetes Mellitus, Type 1, run by Norwegian University of Science and Technology at 2 sites in Norway.
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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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.
Are results available for this study?
The study was stopped early (reason given: skin irritation caused by device). Results are not available in the source record.
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?
difference between Glucopred and the reference method (time frame: 8 days). 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 22 Nov 2016.