Type 1 DiabetesNCT02651181
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes The DREAMED Trail
A study testing HLCL- Hybrid Logic Closed Loop System in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Several groups around the world investigate efforts in developing closed-loop systems. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- HLCL- Hybrid Logic Closed Loop System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2016to 31 Jan 2018
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diabetes duration > 1 year since diagnosis
- Pump therapy for at least 6 months and Experience with sensor use
- Age 18-40
- A1C <10.0 at time of screening visit
- Willing to follow study instructions
- Willing to perform ≥ 5 finger stick blood glucose measurements daily
- Willing to perform required sensor calibrations
- Patient capable of reading and understand instructions in English
Who cannot join
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study drug or device in the last 2 weeks
- Subject has a positive pregnancy screening test
- Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception
- Subject has had a hypoglycemic seizure within the past 5 months prior to screening visit
Show all 16Show fewer
- Subject has had hypoglycemia resulting in loss of consciousness within the past 5 months prior to screening visit
- Subject has had an episode of diabetic ketoacidosis within the past 6 months prior to screening visit
- Subject has a history of a seizure disorder
- Subject has central nervous system or cardiac disorder resulting in syncope
- Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- Subjects with hematocrit lower than the normal reference range or local lab testing
- Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias
- Subjects with a history of adrenal insufficiency
- Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment
- Any disease or condition that may influence the A1C testing e.g abnormal red blood cell indices and iron deficiency, sickle cell disease, hemoglobinopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes -Single-arm, Single-center, in Clinic Study-The DREAMED Trail
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability.
Several groups around the world investigate efforts in developing closed-loop systems. Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system. The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was tested 'In silico' and was proved to be safe and effective. The next step is to test the system in a clinical study in a supervised environment in a camp.
Read more
The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system for overnight use "the GlucoSitter" has a CE mark.
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.
Read the detailed description
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability.
Several groups around the world investigate efforts in developing closed-loop systems. Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system. The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was tested 'In silico' and was proved to be safe and effective. The next step is to test the system in a clinical study in a supervised environment in a camp.
The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system for overnight use "the GlucoSitter" has a CE mark.
The primary objective of the study is to characterize the overall management of the glycemic control using this system including Safety. The data collected in this study will be used to confirm/develop the HLCL System further.
Secondary objectives of this study include evaluation of the HLCL system in a monitored setting (camp) with the following stresses:Exercise, high carbohydrate and high fat meals
This study is a single-arm, single-center, in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy.
Run-in Period:
A total of up to 10 subjects will be enrolled (age 18-40). A minimum of 6 days run-in period with sensor augmented pump will be used to collect sensors and insulin data and to allow the subject to become familiar.
Study Period - Camp:
Following the run-in period subjects will participate in a 5 day, 4 night study period in a camp setting during which the HLCL feature will be studied.
- Conditions
- Type 1 Diabetes
- Being tested
- HLCL- Hybrid Logic Closed Loop System
- 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.
HLCL- Hybrid Logic Closed Loop SystemDevice
All subjects wearing the HLCL System and using it with the closed loop algorithm
| Study group | Role | What they receive |
|---|---|---|
| Closed Loop System | Experimental | Not described Receives: Device: HLCL- Hybrid Logic Closed Loop System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,
Measured: End of the study- day 5 of the camp
Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,during night time (12am-6am)
Measured: End of the study- day 5 of the camp
Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,during day time (6am-12am)
Measured: End of the study- day 5 of the camp
Secondary outcomes (7)
Event rate of Serious Adverse Events
Measured: End of the study- day 5 of the camp
Event rate of Serious Adverse Device Events
Measured: End of the study- day 5 of the camp
Event rate of unanticipated Adverse Device Effects
Measured: End of the study-day 5 of the camp
Incidence of Diabetic Ketoacidosis
Measured: End of the study-day 5 of the camp
Area under the curve of time in the hyperglycemia range
Measured: End of the study-day 5 of the camp
Area Under the curve of time in the hypoglycemic range
Measured: End of the study-day 5 of the camp
Incidence of Severe Hypoglycemia
Measured: End of study -day 5 of the camp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJun 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, MD, Prof, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651181
- Sponsor's protocol ID
- RMC076215ctil
- Status last verified
- Jan 2017
- First submitted
- 7 Jan 2016
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes -Single-arm, Single-center, in Clinic Study-The DREAMED Trail
- ClinicalTrials.gov ID
- NCT02651181
- Acronym / sponsor ID
- RMC076215ctil
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jun 2016
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 8 Jan 2016 (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.
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability.
Several groups around the world investigate efforts in developing closed-loop systems. Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system. The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was tested 'In silico' and was proved to be safe and effective. The next step is to test the system in a clinical study in a supervised environment in a camp.
The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system for overnight use "the GlucoSitter" has a CE mark.
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.
Detailed description
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability.
Several groups around the world investigate efforts in developing closed-loop systems. Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system. The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was tested 'In silico' and was proved to be safe and effective. The next step is to test the system in a clinical study in a supervised environment in a camp.
The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system for overnight use "the GlucoSitter" has a CE mark.
The primary objective of the study is to characterize the overall management of the glycemic control using this system including Safety. The data collected in this study will be used to confirm/develop the HLCL System further.
Secondary objectives of this study include evaluation of the HLCL system in a monitored setting (camp) with the following stresses:Exercise, high carbohydrate and high fat meals
This study is a single-arm, single-center, in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy.
Run-in Period:
A total of up to 10 subjects will be enrolled (age 18-40). A minimum of 6 days run-in period with sensor augmented pump will be used to collect sensors and insulin data and to allow the subject to become familiar.
Study Period - Camp:
Following the run-in period subjects will participate in a 5 day, 4 night study period in a camp setting during which the HLCL feature will be studied.
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: HLCL- Hybrid Logic Closed Loop System |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Diabetes duration > 1 year since diagnosis
- Pump therapy for at least 6 months and Experience with sensor use
- Age 18-40
- A1C <10.0 at time of screening visit
- Willing to follow study instructions
Key exclusion criteria (16 listed)
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study drug or device in the last 2 weeks
- Subject has a positive pregnancy screening test
- Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception
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 |
|---|---|---|
| HLCL- Hybrid Logic Closed Loop SystemAll subjects wearing the HLCL System and using it with the closed loop algorithm | Device | Closed Loop System |
Primary outcome
Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,
Time frame: End of the study- day 5 of the camp
Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,during night time (12am-6am)
Time frame: End of the study- day 5 of the camp
Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL,during day time (6am-12am)
Time frame: End of the study- day 5 of the camp
7 secondary outcomes
Event rate of Serious Adverse Events
Time frame: End of the study- day 5 of the camp
Event rate of Serious Adverse Device Events
Time frame: End of the study- day 5 of the camp
Event rate of unanticipated Adverse Device Effects
Time frame: End of the study-day 5 of the camp
Incidence of Diabetic Ketoacidosis
Time frame: End of the study-day 5 of the camp
Area under the curve of time in the hyperglycemia range
Time frame: End of the study-day 5 of the camp
Area Under the curve of time in the hypoglycemic range
Time frame: End of the study-day 5 of the camp
Incidence of Severe Hypoglycemia
Time frame: End of study -day 5 of the camp
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 2 Jan 2020.
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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, MD, Prof principal investigator
Rabin 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 HLCL- Hybrid Logic Closed Loop System in people with Type 1 Diabetes, 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 8 inclusion and 16 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 2 Jan 2020. 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?
Time in range of sensor glucose data between 70 mg/dL to 180 mg/dL, (time frame: End of the study- day 5 of the camp). The study lists 3 primary outcomes in all. 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 2 Jan 2020.