To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days.NCT02127827
Multiday Fully Closed Loop Insulin Delivery in Monitored Outpatient Conditions
A study of To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days. and To Assess Effectiveness in Maintaining Patients' Glucose Levels in the Target Range of 70 to 180 mg/dl, Measured by Blood Glucose Sensor., run by Sheba Medical Center at 1 site in Israel.
Trial summary
Insulin replacement therapy is absolutely required for patients with Type 1 diabetes. The insulin pump provides for continuous subcutaneous insulin infusion (CSII), which can approximate the insulin release patterns of the normal pancreas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days., To Assess Effectiveness in Maintaining Patients' Glucose Levels in the Target Range of 70 to 180 mg/dl, Measured by Blood Glucose Sensor., To Evaluate the User Experience With a Closed Loop System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- May 2014to May 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 to 70 years of age at time of screening
- Subject's weight is between 50 and 120 kg
- A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
- Subject has ongoing use of an insulin pump ≥ 6 months prior to screening
- Subject has an glycated hemoglobin value ≤ 9.0% demonstrated at the time of enrollment.
- Subject uses a rapid-acting analogue insulin in his/her pump
- Patient is willing to undergo all study procedures
Who cannot join
- Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
- Subject has unresolved adverse skin condition, or unable to tolerate tape adhesive, in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
- Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
- Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), congestive heart failure, ventricular rhythm disturbances, or thromboembolic disease within the past 6 months
- Subject has a presence of a cardiac pacemaker or any other device that may be sensitive to radio frequency telemetry
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- Subject has any condition, including screening lab values that in the opinion of the Investigator may preclude him/her from participating in the study and completing study related procedures
- Subject is actively participating in other investigational study (drug or device)
- Subjects who consume alcohol daily
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Ramat Gan
Revital Dvir, 972-3-5302021, endo.r@sheba.health.gov.il
Jacob Ilany, Dr
About this study
Insulin replacement therapy is absolutely required for patients with Type 1 diabetes. The insulin pump provides for continuous subcutaneous insulin infusion (CSII), which can approximate the insulin release patterns of the normal pancreas. Timely and accurate knowledge of ambient glucose levels is important for insulin dose adjustments. Typically, glucose values are measured volitionally, several times a day, using capillary "fingerstick" samples. In addition, glucose in the interstitial fluid can be measured automatically and continuously using implantable glucose oxidase-based sensors. Recent study showed that this continuous measurement of glucose levels allows for a fully automated "closed-loop" insulin replacement therapy which requires an algorithm that receives glucose data, calculates an appropriate insulin dose, and directs the pump to deliver the insulin dose.The need for development of a closed-loop insulin replacement system that integrates insulin delivery, glucose measurement, and control subsystems will present several challenges to biomedical engineers.
- Conditions
- To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days., To Assess Effectiveness in Maintaining Patients' Glucose Levels in the Target Range of 70 to 180 mg/dl, Measured by Blood Glucose Sensor., To Evaluate the User Experience With a Closed Loop System
- Being tested
- Automated Ambulatory Glycemic Controller (AAGC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Ambulatory Glycemic Controller (AAGC)Device
| Study group | Role | What they receive |
|---|---|---|
| investigational device off | Experimental | Not described Receives: Device: Automated Ambulatory Glycemic Controller (AAGC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
time in glycemic target
Measured: day 4
Secondary outcomes (3)
Glucose AUC (area under the curve) below 3.8 mmol/l (70 mg/dL) measured by Enlite glucose sensor
Measured: day 4
Glucose AUC (area under the curve) above 10mmol/l (180 mg/dL) measured by Enlite glucose sensor
Measured: day 4
Number of hypoglycemic events, defined as a sensor glucose of < 3.8 mmol/l (70 mg/dL ) measured by Enlite glucose sensor
Measured: day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days.Studies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Ohad Cohen, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127827
- Sponsor's protocol ID
- SHEBA-13-0834-OC-CTIL
- Status last verified
- Apr 2014
- First submitted
- 29 Apr 2014
- Last updated
- 1 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiday Fully Closed Loop Insulin Delivery in Monitored Outpatient Conditions
- ClinicalTrials.gov ID
- NCT02127827
- Acronym / sponsor ID
- SHEBA-13-0834-OC-CTIL
- Conditions
- To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days., To Assess Effectiveness in Maintaining Patients' Glucose Levels in the Target Range of 70 to 180 mg/dl, Measured by Blood Glucose Sensor., To Evaluate the User Experience With a Closed Loop System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2014
- Primary completion
- May 2016 (estimated)
- First posted
- 1 May 2014 (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.
Insulin replacement therapy is absolutely required for patients with Type 1 diabetes. The insulin pump provides for continuous subcutaneous insulin infusion (CSII), which can approximate the insulin release patterns of the normal pancreas. Timely and accurate knowledge of ambient glucose levels is important for insulin dose adjustments. Typically, glucose values are measured volitionally, several times a day, using capillary "fingerstick" samples. In addition, glucose in the interstitial fluid can be measured automatically and continuously using implantable glucose oxidase-based sensors. Recent study showed that this continuous measurement of glucose levels allows for a fully automated "closed-loop" insulin replacement therapy which requires an algorithm that receives glucose data, calculates an appropriate insulin dose, and directs the pump to deliver the insulin dose.The need for development of a closed-loop insulin replacement system that integrates insulin delivery, glucose measurement, and control subsystems will present several challenges to biomedical engineers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| investigational device off | Experimental | Device: Automated Ambulatory Glycemic Controller (AAGC) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is 18 to 70 years of age at time of screening
- Subject's weight is between 50 and 120 kg
- A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
- Subject has ongoing use of an insulin pump ≥ 6 months prior to screening
- Subject has an glycated hemoglobin value ≤ 9.0% demonstrated at the time of enrollment.
Key exclusion criteria (9 listed)
- Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
- Subject has unresolved adverse skin condition, or unable to tolerate tape adhesive, in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
- Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
- Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), congestive heart failure, ventricular rhythm disturbances, or thromboembolic disease within the past 6 months
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 |
|---|---|---|
| Automated Ambulatory Glycemic Controller (AAGC) | Device | investigational device off |
Primary outcome
time in glycemic target
Time frame: day 4
3 secondary outcomes
Glucose AUC (area under the curve) below 3.8 mmol/l (70 mg/dL) measured by Enlite glucose sensor
Time frame: day 4
Glucose AUC (area under the curve) above 10mmol/l (180 mg/dL) measured by Enlite glucose sensor
Time frame: day 4
Number of hypoglycemic events, defined as a sensor glucose of < 3.8 mmol/l (70 mg/dL ) measured by Enlite glucose sensor
Time frame: day 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days. and To Assess Effectiveness in Maintaining Patients' Glucose Levels in the Target Range of 70 to 180 mg/dl, Measured by Blood Glucose Sensor., run by Sheba 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 May 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ohad Cohen, Prof (972-526667597, ohdcohen@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time in glycemic target (time frame: day 4). 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 1 May 2014.