Type 1 DiabetesNCT02776696
Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2
A study testing Advanced Hybrid Closed Loop System and Hybrid Closed Loop System in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of the study is to compare two closed-loop strategies in terms of glycemic control in Type 1 Diabetes during a camp setting. The proposed study is a four-segment feasibility study. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Advanced Hybrid Closed Loop System and Hybrid Closed Loop System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2016to 14 Aug 2019
- 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 40 years
- All sexes
- No healthy volunteers
- Child, 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
- Age10-40 years: Age 10-30 for segments 1-3, Age 14-40 for segment 4.
- 7>HbA1c <10.0 at time of screening visit for segments 1 and 2, <10.0 at segments 3 and 4.
- Willing to follow study instructions
- Willing to perform ≥ 3 finger stick blood glucose measurements daily
Show all 9Show fewer
- Willing to perform required sensor calibrations
- Patient capable of reading and understand instructions in English
- Willing to have an adult experienced in the management of diabetes to live with during the outpatient phase of the protocol.
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
- 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 17Show 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 local lab testing
- Subjects with a history or findings on screening electrocardiogram of any cardiac arrhythmia
- 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 HbA1c testing
- Subject needs to travel by air during the study duration.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to compare two closed-loop strategies in terms of glycemic control in Type 1 Diabetes during a camp setting.
The proposed study is a four-segment feasibility study. One segment is a proof of concept study (with two parts) conducted as in-patient clinic study ,the second segment is two-arms, cross-over, randomized and single-center and the third segment is four-arms, parallel, randomized and single-center, in diabetes camp study in subjects with type 1 diabetes on insulin pump therapy and the forth segment is a single arm feasibility in a diabetes camp setting followed by a 3 weeks period at home.
Read more
Segment 1 will be divided into two parts: part 1 is a single arm pilot study aim to asses logistical and safety issues in 12 patients and part 2 is a randomized cross over study aim to evaluate glucose performance using closed-loop control. Part 2-is a randomized cross-over (two arms) in-patient study: A total of 12 patients will participate in this part of the study. Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment, each period will last 36 hours in hospital setting. During the first period, glycemic control will be controlled by the Hybrid closed-loop system and during the second period by Hybrid Logic closed-loop system. The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned.
Segment 2 is a randomized cross-over (two arms) Camp Study including up to 30 patients. Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment, each period will last 2days in a camp setting, the total duration of the camp will be up to 6 days. In one period, glycemic control will be controlled by the Hybrid closed-loop system and another period by Hybrid Logic closed-loop system. The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned.
Segment 3 is a randomized, parallel (four arm) Camp Study including up to 80 patients. Following the run-in period subjects will be randomized to participate in one of 4 intervention arms of closed-loop treatment in camp settings. The duration of the camp will be 12 days in which glycemic control will be controlled by one of 4 versions of closed-loop system: Hybrid Closed Loop (HCL) or one of 3 versions of Advanced Hybrid Closed Loop (AHCL).
Segment 4 is a single arm, feasibility study in a diabetes camp setting followed by a three week period at home. After the completion of segments 1-3, the AHCL system will be optimized and a new version of the system will be created for use in segment 4. Up to 20 subjects will participate in this part of the study. Following a minimum of 5 days run-in period, subjects will be placed in a camp setting and closed loop will be initiated. Subjects will remain in closed loop for 5 days and will have 3 days of challenges, including missed meal bolus, late meal bolus and moderate-intensity exercise. At the conclusion of the camp, subjects will continue to use the system at home in Auto Mode for a period of 21 days.
- Conditions
- Type 1 Diabetes
- Being tested
- Advanced Hybrid Closed Loop System, Hybrid Closed Loop System
- Keywords
- Closed Loop, Artificial Pancreas
- 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
Also called AHCL
Hybrid Closed Loop SystemDevice
Also called HCL
| Study group | Role | What they receive |
|---|---|---|
| Advanced HybridClosed Loop System (AHCL) | Experimental | Advanced Hybrid Closed Loop System (AHCL) - all subjects wearing the study system during 36 hours in the clinic during segment 1or 2 days in a camp setting during segment 2 or 12 days in a camp setting during segment 3 or 5 days in a camp setting and 21 days at home during segment 4. Receives: Device: Advanced Hybrid Closed Loop System |
| Hybrid Closed Loop System (HCL) | Experimental | Hybrid Closed Loop System (HCL) - all subjects wearing the study system during:
36 hours in the clinic during segment 1or 2 days in a camp setting during segment 2 or 12 days in a camp setting during segment 3 Receives: Device: Hybrid Closed Loop System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of glucose sensor readings within 70 to 180 mg/dl
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Secondary outcomes (25)
Area Under the Curve of glucose sensor readings below 70 mg/dl
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of glucose sensor readings below 70 mg/dl
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Area Under the Curve of glucose sensor readings above 180 mg/dl
Measured: Day 21 for segments 1-3 and day 31 for segment 4
Percentage of glucose sensor readings above 180 mg/dl
Measured: Day 20
Average of glucose sensor readings
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Standard Deviation of glucose sensor readings
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Time in glucose range of 70-180 mg/dl during day time (6am-12am)
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Time in glucose range of 70-180 mg/dl during night time (12am-6am)
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Area Under the Curve of glucose sensor readings above 250 mg/dL
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Area Under the Curve of glucose sensor readings above 300 mg/dL
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of glucose sensor readings above 250 mg/dL
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of glucose sensor readings above 300 mg/dL
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Area Under the Curve of glucose sensor readings below 50 mg/dL
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Area Under the Curve of glucose sensor readings below 60 mg/dL
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of glucose sensor readings below 50 mg/dL
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of glucose sensor readings below 60 mg/dL
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of time in Closed Loop
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Sensor mean absolute relative difference (MARD)
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Total insulin dose
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Serious Adverse Events (SAE)
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Serious Adverse Device Events (SADE)
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Unanticipated Adverse Device Effects (UADE)
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Incidence of Severe Hypoglycemia
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Incidence of Diabetic Ketoacidosis (DKA)
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Closed-loop acceptance questionnaire
The questionnaire contains 5 sections evaluating the user acceptance of the study devise (general satisfaction, comparison to previous treatment, importance of the system, expectations from the system and suggestions for improvement) each section consists of 1-31 questions each, with specific scales for each of the questions. Subscales are not combined to compute a total score.
Measured: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJun 2016
- Primary completion14 Aug 2019
- Study completion14 Aug 2019
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
- Randomised
- Intervention model
- Crossover
- Model description
- segment 1 part 1 is a single arm study, segment 1 part 2 is a is a crossover study, segment 2 is a randomized crossover study , segment 3 is a parallel study and segment 4 is a single arm study
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776696
- Sponsor's protocol ID
- rmc082315ctil
- Status last verified
- Sep 2018
- First submitted
- 16 May 2016
- Last updated
- 27 Dec 2019
- 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 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2
- ClinicalTrials.gov ID
- NCT02776696
- Acronym / sponsor ID
- rmc082315ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Closed Loop, Artificial Pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 18 May 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 the study is to compare two closed-loop strategies in terms of glycemic control in Type 1 Diabetes during a camp setting.
The proposed study is a four-segment feasibility study. One segment is a proof of concept study (with two parts) conducted as in-patient clinic study ,the second segment is two-arms, cross-over, randomized and single-center and the third segment is four-arms, parallel, randomized and single-center, in diabetes camp study in subjects with type 1 diabetes on insulin pump therapy and the forth segment is a single arm feasibility in a diabetes camp setting followed by a 3 weeks period at home.
Segment 1 will be divided into two parts: part 1 is a single arm pilot study aim to asses logistical and safety issues in 12 patients and part 2 is a randomized cross over study aim to evaluate glucose performance using closed-loop control. Part 2-is a randomized cross-over (two arms) in-patient study: A total of 12 patients will participate in this part of the study. Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment, each period will last 36 hours in hospital setting. During the first period, glycemic control will be controlled by the Hybrid closed-loop system and during the second period by Hybrid Logic closed-loop system. The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned.
Segment 2 is a randomized cross-over (two arms) Camp Study including up to 30 patients. Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment, each period will last 2days in a camp setting, the total duration of the camp will be up to 6 days. In one period, glycemic control will be controlled by the Hybrid closed-loop system and another period by Hybrid Logic closed-loop system. The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned.
Segment 3 is a randomized, parallel (four arm) Camp Study including up to 80 patients. Following the run-in period subjects will be randomized to participate in one of 4 intervention arms of closed-loop treatment in camp settings. The duration of the camp will be 12 days in which glycemic control will be controlled by one of 4 versions of closed-loop system: Hybrid Closed Loop (HCL) or one of 3 versions of Advanced Hybrid Closed Loop (AHCL).
Segment 4 is a single arm, feasibility study in a diabetes camp setting followed by a three week period at home. After the completion of segments 1-3, the AHCL system will be optimized and a new version of the system will be created for use in segment 4. Up to 20 subjects will participate in this part of the study. Following a minimum of 5 days run-in period, subjects will be placed in a camp setting and closed loop will be initiated. Subjects will remain in closed loop for 5 days and will have 3 days of challenges, including missed meal bolus, late meal bolus and moderate-intensity exercise. At the conclusion of the camp, subjects will continue to use the system at home in Auto Mode for a period of 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- segment 1 part 1 is a single arm study, segment 1 part 2 is a is a crossover study, segment 2 is a randomized crossover study , segment 3 is a parallel study and segment 4 is a single arm study
| Arm | Type | Receives |
|---|---|---|
| Advanced HybridClosed Loop System (AHCL) | Experimental | Device: Advanced Hybrid Closed Loop SystemAdvanced Hybrid Closed Loop System (AHCL) - all subjects wearing the study system during 36 hours in the clinic during segment 1or 2 days in a camp setting during segment 2 or 12 days in a camp setting during segment 3 or 5 days in a camp setting and 21 days at home during segment 4. |
| Hybrid Closed Loop System (HCL) | Experimental | Device: Hybrid Closed Loop SystemHybrid Closed Loop System (HCL) - all subjects wearing the study system during: 36 hours in the clinic during segment 1or 2 days in a camp setting during segment 2 or 12 days in a camp setting during segment 3 |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Diabetes duration > 1 year since diagnosis
- Pump therapy for at least 6 months and experience with sensor use
- Age10-40 years: Age 10-30 for segments 1-3, Age 14-40 for segment 4.
- 7>HbA1c <10.0 at time of screening visit for segments 1 and 2, <10.0 at segments 3 and 4.
- Willing to follow study instructions
Key exclusion criteria (17 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
- 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 |
|---|---|---|
| Advanced Hybrid Closed Loop SystemAlso: AHCL | Device | Advanced HybridClosed Loop System (AHCL) |
| Hybrid Closed Loop SystemAlso: HCL | Device | Hybrid Closed Loop System (HCL) |
Primary outcome
Percentage of glucose sensor readings within 70 to 180 mg/dl
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
25 secondary outcomes
Area Under the Curve of glucose sensor readings below 70 mg/dl
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of glucose sensor readings below 70 mg/dl
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Area Under the Curve of glucose sensor readings above 180 mg/dl
Time frame: Day 21 for segments 1-3 and day 31 for segment 4
Percentage of glucose sensor readings above 180 mg/dl
Time frame: Day 20
Average of glucose sensor readings
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Standard Deviation of glucose sensor readings
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Time in glucose range of 70-180 mg/dl during day time (6am-12am)
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Time in glucose range of 70-180 mg/dl during night time (12am-6am)
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Area Under the Curve of glucose sensor readings above 250 mg/dL
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Area Under the Curve of glucose sensor readings above 300 mg/dL
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of glucose sensor readings above 250 mg/dL
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of glucose sensor readings above 300 mg/dL
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Area Under the Curve of glucose sensor readings below 50 mg/dL
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Area Under the Curve of glucose sensor readings below 60 mg/dL
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of glucose sensor readings below 50 mg/dL
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of glucose sensor readings below 60 mg/dL
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Percentage of time in Closed Loop
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Sensor mean absolute relative difference (MARD)
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Total insulin dose
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Serious Adverse Events (SAE)
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Serious Adverse Device Events (SADE)
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Unanticipated Adverse Device Effects (UADE)
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Incidence of Severe Hypoglycemia
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Incidence of Diabetic Ketoacidosis (DKA)
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
Closed-loop acceptance questionnaire
Time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
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 27 Dec 2019.
- 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 Phillip, Prof principal investigator
Schneider Children's 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 Advanced Hybrid Closed Loop System and Hybrid 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 9 inclusion and 17 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 27 Dec 2019. 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?
Percentage of glucose sensor readings within 70 to 180 mg/dl (time frame: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion). 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 27 Dec 2019.