Type 1 DiabetesNCT04901143
Meal Handling of Advanced Closed Loop Insulin Delivery.
A study testing Advanced hybrid closed loop system in people with Type 1 Diabetes, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The study will Compare meal related glycemic indices following 2 types of meal announcement: 1. Conventional assessment of carb content plus carb equivalence of proteins and fat 2. Algorithm device optimal universal meal announce equivalent Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Advanced hybrid closed loop system
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Jul 2021to 1 Jan 2022
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 20 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 and rtCGM ≥ 6 months prior to screening
- current use of 670G 4.0 pump
- Subject has an A1C value ≤ 10.0% demonstrated at the time of enrollment.
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- Subject uses a rapid-acting analogue insulin in his/her pump
- Patient is willing to undergo all study procedures
- English proficiency
- Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
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
- Subjects currently taking adjunct therapy with SGLT2-inhibitors, Amylin.
- Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
- Gastroparesis, uncontrolled thyroid disorder, Addison disease,. , Pituitary insufficiency
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- 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
- 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
- Use of CGM (other than per protocol) throughout the duration of the study
- Use of Hydroxyurea medication
Trial locations and contacts
1 site in 1 country.
About this study
The study will Compare meal related glycemic indices following 2 types of meal announcement:
- Conventional assessment of carb content plus carb equivalence of proteins and fat
- Algorithm device optimal universal meal announce equivalent
- Conditions
- Type 1 Diabetes
- Being tested
- Advanced hybrid 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.
Advanced hybrid closed loop systemDevice
Phase 1: meals in open loop- 3 weeks Phase 2: closed loop conventional meal announcement- 3 weeks Phase 3: closed loop, pre define universal bolus- 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
AUC glucose 300 minutes post meal
Measured: 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start17 Jul 2021
- Primary completion30 Dec 2021
- Study completion1 Jan 2022
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.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Prof. Amir Tirosh, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901143
- Sponsor's protocol ID
- Sheba-21-8159-at-ctil
- Status last verified
- May 2022
- First submitted
- 24 May 2021
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meal Handling of Advanced Closed Loop Insulin Delivery.
- ClinicalTrials.gov ID
- NCT04901143
- Acronym / sponsor ID
- Sheba-21-8159-at-ctil
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Medtronic
- Study start
- 17 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 25 May 2021 (actual)
- 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 study will Compare meal related glycemic indices following 2 types of meal announcement:
- Conventional assessment of carb content plus carb equivalence of proteins and fat
- Algorithm device optimal universal meal announce equivalent
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is 20 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 and rtCGM ≥ 6 months prior to screening
- current use of 670G 4.0 pump
Key exclusion criteria (13 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
- Subjects currently taking adjunct therapy with SGLT2-inhibitors, Amylin.
- Subject has a history of seizure disorder unrelated to diabetes within the past 12 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 |
|---|---|---|
| Advanced hybrid closed loop systemPhase 1: meals in open loop- 3 weeks Phase 2: closed loop conventional meal announcement- 3 weeks Phase 3: closed loop, pre define universal bolus- 3 weeks | Device | – |
Primary outcome
Time in range
Time frame: 300 minutes
AUC glucose 300 minutes post meal
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 12 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced hybrid closed loop system in people with Type 1 Diabetes, 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 10 inclusion and 13 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 12 May 2022. 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 (time frame: 300 minutes). 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 12 May 2022.