Diabetes, Type INCT00541515
Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm
A study testing continuous glucose sensors and insulin pump in people with Diabetes, Type I, run by Rabin Medical Center at 1 site in Israel.
Trial summary
An open interventional data collection study in order to build a database to close the loop between glucose sensor and insulin pump. background: The ultimate goal in diabetes treatment is to develop an autonomous insulin delivery system (artificial pancreas) capable of continuous glucose sensing, thereby mimicking the… Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Diabetes, Type I
- What is being tested?
- continuous glucose sensors and insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2007to Sep 2015
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes type 1 for at least one year.
- ages >10 years.
- signed informed consent form.
- willing to cooperate with all study requirements.
Who cannot join
- Sensor allergy.
- Psychiatrist diseases.
- other chronic diseases.
- Participation in another study that involves a medicine or a medical device.Subjects have to finish participating in other studies at least 30 days before joining this study. Each subject can participate in this study only once.
Trial locations and contacts
1 site in 1 country.
About this study
An open interventional data collection study in order to build a database to close the loop between glucose sensor and insulin pump.
background: The ultimate goal in diabetes treatment is to develop an autonomous insulin delivery system (artificial pancreas) capable of continuous glucose sensing, thereby mimicking the physiologic function of the islet beta cells and freeing the patient from the need for constant calculations of daily insulin and carbohydrates. Several prototypes of closed-loop system have been developed in recent years, based on different types of control algorithms, to establish the connection between the sensor and the insulin pump. Current research in the formulation of this type of subcutaneous closed-loop system still faces major challenges, therefore, there is a need for further study and evaluation.
Read more
Objectives:
- To evaluate the lag time of the effect of subcutaneous insulin infusion on blood glucose levels by using continuous glucose sensor
- To measure the insulin sensitivity as expressed by changes in blood glucose levels after s.c insulin infusion .
- To evaluate real time sensor calibration algorithms based on the measured lag times
- Collecting clinical data in order to develop and evaluate mathematical models which will serve a base to simulators.
- Developing and accessing advanced learning and control algorithms as a step towards developing an artificial pancreas
- Conditions
- Diabetes, Type I
- Being tested
- continuous glucose sensors and insulin pump
- Keywords
- Type 1 diabetes, Artificial pancreas, Insulin Pump
- 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.
continuous glucose sensors and insulin pumpDevice
continuous glucose sensors and insulin pump
| Study group | Role | What they receive |
|---|---|---|
| closed loop system | Experimental | Device: continuous glucose sensors and insulin pump Receives: Device: continuous glucose sensors and insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose levels
Measured: countinuasly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes, Type IStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Professor, Principal investigator, Schneider Children Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541515
- Sponsor's protocol ID
- rmc004706ctil
- Status last verified
- Apr 2016
- First submitted
- 8 Oct 2007
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nimri R, Atlas E, Ajzensztejn M, Miller S, Oron T, Phillip M. Feasibility study of automated overnight closed-loop glucose control under MD-logic artificial pancreas in patients with type 1 diabetes: the DREAM Project. Diabetes Technol Ther. 2012 Aug;14(8):728-35. doi: 10.1089/dia.2012.0004.
PubMed 22853723Atlas E, Nimri R, Miller S, Grunberg EA, Phillip M. MD-logic artificial pancreas system: a pilot study in adults with type 1 diabetes. Diabetes Care. 2010 May;33(5):1072-6. doi: 10.2337/dc09-1830. Epub 2010 Feb 11.
PubMed 20150292
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm
- ClinicalTrials.gov ID
- NCT00541515
- Acronym / sponsor ID
- rmc004706ctil
- Conditions
- Diabetes, Type I
- Keywords
- Type 1 diabetes, Artificial pancreas, Insulin Pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Oct 2007 (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.
An open interventional data collection study in order to build a database to close the loop between glucose sensor and insulin pump.
background: The ultimate goal in diabetes treatment is to develop an autonomous insulin delivery system (artificial pancreas) capable of continuous glucose sensing, thereby mimicking the physiologic function of the islet beta cells and freeing the patient from the need for constant calculations of daily insulin and carbohydrates. Several prototypes of closed-loop system have been developed in recent years, based on different types of control algorithms, to establish the connection between the sensor and the insulin pump. Current research in the formulation of this type of subcutaneous closed-loop system still faces major challenges, therefore, there is a need for further study and evaluation.
Objectives:
- To evaluate the lag time of the effect of subcutaneous insulin infusion on blood glucose levels by using continuous glucose sensor
- To measure the insulin sensitivity as expressed by changes in blood glucose levels after s.c insulin infusion .
- To evaluate real time sensor calibration algorithms based on the measured lag times
- Collecting clinical data in order to develop and evaluate mathematical models which will serve a base to simulators.
- Developing and accessing advanced learning and control algorithms as a step towards developing an artificial pancreas
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| closed loop system | Experimental | Device: continuous glucose sensors and insulin pumpDevice: continuous glucose sensors and insulin pump |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes type 1 for at least one year.
- ages >10 years.
- signed informed consent form.
- willing to cooperate with all study requirements.
Key exclusion criteria (4 listed)
- Sensor allergy.
- Psychiatrist diseases.
- other chronic diseases.
- Participation in another study that involves a medicine or a medical device.Subjects have to finish participating in other studies at least 30 days before joining this study. Each subject can participate in this study only once.
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 |
|---|---|---|
| continuous glucose sensors and insulin pumpcontinuous glucose sensors and insulin pump | Device | closed loop system |
Primary outcome
Blood glucose levels
Time frame: countinuasly
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 8 Apr 2016.
- Derived from this study: PubMed 22853723Nimri R, Atlas E, Ajzensztejn M, Miller S, Oron T, Phillip M. Feasibility study of automated overnight closed-loop glucose control under MD-logic artificial pancreas in patients with type 1 diabetes: the DREAM Project. Diabetes Technol Ther. 2012 Aug;14(8):728-35. doi: 10.1089/dia.2012.0004.
- Derived from this study: PubMed 20150292Atlas E, Nimri R, Miller S, Grunberg EA, Phillip M. MD-logic artificial pancreas system: a pilot study in adults with type 1 diabetes. Diabetes Care. 2010 May;33(5):1072-6. doi: 10.2337/dc09-1830. Epub 2010 Feb 11.
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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.
Moshe Phillip, Professor principal investigator
Schneider Children Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous glucose sensors and insulin pump in people with Diabetes, Type I, run by Rabin Medical Center at 1 site in Israel.
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 4 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 8 Apr 2016. 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 Israel. 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 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?
Blood glucose levels (time frame: countinuasly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00541515, which also lists 2 linked publications.
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 8 Apr 2016.