Type 1 DiabetesDREAMEDNCT02692547
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes
A study testing Hybrid-logic closed loop system in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc..
Trial summary
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Hybrid-logic closed loop system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes duration > 1 year since diagnosis
- Sensor augmented Pump for at least 6 months
- Age 18-25
- 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 6 months prior to screening visit
Show all 15Show fewer
- Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
- Subject has had an episode of diabetic ketoacidosis (DKA) 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 per POC 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
About this study
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.
Read the detailed description
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 10 subjects will be enrolled (age 18-25). A minimum of 6 days run-in period with the 640G (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 an camp setting during which the CL feature will be studied.
Subjects will receive 3 meals each day, one night they receive a high fat dinner, one morning they will receive breakfast high in carbohydrates.
Subjects will be asked to exercise for up to 60 minutes on one day during their study period.
Subjects will be asked to take a minimum of 5 fingersticks a day (before each meal, morning and before bedtime)
- Conditions
- Type 1 Diabetes
- Being tested
- 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.
Hybrid-logic closed loop systemDevice
All patients get to wear the pump
| Study group | Role | What they receive |
|---|---|---|
| Hybrid-logic closed loop system | Other | All patients get to wear the pump. only 1 arm. There is no comparator in this study, as all patients wear the pump. Receives: Device: Hybrid-logic closed loop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive endpoints
Time in different range SG 70 mg/dL ≤ SG ≤ 180 mg/dL
Measured: after 4 days of camp
Secondary outcomes (1)
Descriptive endpoints
Serious Adverse Events (SAE)
Measured: after 4 days of camp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Study Cancelled
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moshe Philip, MD, Principal investigator, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692547
- Sponsor's protocol ID
- CEP312
- Acronym
- DREAMED
- Status last verified
- Jan 2018
- First submitted
- 3 Dec 2015
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. 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
- ClinicalTrials.gov ID
- NCT02692547
- Acronym / sponsor ID
- DREAMED / CEP312
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Feb 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.
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.
Detailed description
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 10 subjects will be enrolled (age 18-25). A minimum of 6 days run-in period with the 640G (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 an camp setting during which the CL feature will be studied.
Subjects will receive 3 meals each day, one night they receive a high fat dinner, one morning they will receive breakfast high in carbohydrates.
Subjects will be asked to exercise for up to 60 minutes on one day during their study period.
Subjects will be asked to take a minimum of 5 fingersticks a day (before each meal, morning and before bedtime)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid-logic closed loop system | Other | Device: Hybrid-logic closed loop systemAll patients get to wear the pump. only 1 arm. There is no comparator in this study, as all patients wear the pump. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diabetes duration > 1 year since diagnosis
- Sensor augmented Pump for at least 6 months
- Age 18-25
- A1C <10.0 at time of screening visit
- Willing to follow study instructions
Key exclusion criteria (15 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 |
|---|---|---|
| Hybrid-logic closed loop systemAll patients get to wear the pump | Device | Hybrid-logic closed loop system |
Primary outcome
Descriptive endpoints
Time frame: after 4 days of camp
Time in different range SG 70 mg/dL ≤ SG ≤ 180 mg/dL
1 secondary outcome
Descriptive endpoints
Time frame: after 4 days of camp
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Individual participant dataSharing planned: No
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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 Philip, MD principal investigator
National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid-logic closed loop system in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc..
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 15 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: withdrawn, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Descriptive endpoints (time frame: after 4 days of camp). 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 19 Jan 2018.