Type 1 Diabetes MellitusPhase 2/3NCT03840278
The Bihormonal iLet Bionic Pancreas Feasibility Study
A Phase 2/3 study testing Bihormonal iLet Bionic Pancreas, Insulin-only Bionic Pancreas and Dasiglucagon in people with Type 1 Diabetes Mellitus, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Bihormonal iLet Bionic Pancreas, Insulin-only Bionic Pancreas and Dasiglucagon
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 3 Jul 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and have had clinical type 1 diabetes for at least one year
- Diabetes managed using an insulin pump for ≥ 3 months
- Prescription medication regimen stable for > 1 month (except for medications that will not affect the safety of the participant and are not expected to affect any outcome of the study, in the judgement of the principal investigator)
- Willing to wear one Dexcom CGM sensor, and up to two steel cannula infusion sets (6 mm Contact Detach) and change infusion sets frequently (if the subject is known not to tolerate steel infusion sets then a plastic set may be used)
- Have used a CGM for at least one cumulative month over the last 24 months
- Willing to stay within a 250-mile radius of the designated base throughout the study. Air travel is not permitted.
- Informed consent obtained before any trial-related activities
- Have a designated contact (an adult ≥ 18 years of age) willing to serve as an emergency contact for them throughout the study.
Who cannot join
- Unable to provide informed consent (e.g. impaired cognition or judgment)
- Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the iLet, impaired memory, unable to speak and read English)
- Current participation in another clinical trial with administration of investigational drug.
- Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the participant
- Previous exposure to dasiglucagon (otherwise known as ZP4207)
- Pregnant (positive urine HCG), breast feeding, plan to become pregnant in the next 12 months, or sexually active without use of contraception
Show all 36Show fewer
- Subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.
- Acceptable contraception methods include:Oral contraceptive pills (OCP), Intrauterine Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as Implanon, Nexplanon), Vaginal ring (such as Nuvaring), Progestin shot (such as Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis
- Current alcohol abuse (intake averaging >4 drinks daily in last 30 days) or other substance abuse (use within the last 3 months of controlled substances other than marijuana without a prescription)
- Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)
- Renal failure on dialysis
- History of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy
- Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. exercise of intensity up to 6 METS) despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting
- Abnormal EKG consistent with increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, proximal LAD critical stenosis (Wellen's sign), or prolonged QT interval (> 440 ms). Other EKG findings, including stable Q waves, are not grounds for exclusion as long as the participant is not excluded according to other criteria. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.
- Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV
- History of TIA or stroke in the last 12 months
- History of liver disease that is expected to interfere with the anti-hypoglycemic action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (e.g. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion.
- Personal history of pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease
- a.Fractionated metanephrines will be tested to rule out pheochromocytoma in patients with symptoms that could be related to a catecholamine secreting tumor, including those with: Episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension, Paroxyms of tachycardia, pallor or headache
- History of adrenal disease or tumor that has not undergone characterization for endocrine function
- Hypertension with systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg despite treatment
- Recent history of diabetic ketoacidosis (DKA) or severe hypoglycemia in the last 6 months. Severe hypoglycemia is defined as an event that required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that he/she was unable to treat himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma.
- History of more than 1 episode of DKA requiring hospitalization in the last 2 years
- History of more than 1 episode of severe hypoglycemia in the last year.
- Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with anti-psychotic medications that are known to affect glucose regulation.
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
- Unable or unwilling to completely avoid acetaminophen for duration of study
- Established history of allergy or severe reaction to adhesive or tape that must be used in the study
- History of adverse reaction to glucagon (including allergy) besides nausea or vomiting
- History of severe hypersensitivity to milk proteins or lactose
- History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight
- Current or planned use of SGLT2 inhibitors (prior use more than 3 months prior to enrollment is acceptable; SGLT2 inhibitors should not be initiated during the trial)
- If using GLP1, pramlintide, or metformin must be on a stable dose for 3 months prior to enrollment (these agents should not be initiated during the trial)
- Required use of 2 or more steroid bursts in the 6 months prior to the trial
- History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
- Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes.
Read the detailed description
Our objective is to conduct a home-use study testing the Gen 3.2 iLet bionic pancreas system in the insulin-only configuration and the bihormonal configuration with dasiglucagion in 10 adult subjects (≥ 18 years old) with type 1 diabetes in a random-order crossover study under real-world conditions. The study will assess the safety and reliability of both iLet configurations. Our primary objective is to assess whether the iLet operates as designed comparing the insulin-only configuration of the Gen 3.2 iLet bionic pancreas system with the bihormonal configuration of the device using dasiglucagon at a concentration of 4 mg/ml. Our secondary objective is to assess the impact of both configurations of the Gen 3.2 iLet bionic pancreas system on glycemic control, quality of life, and treatment satisfaction among study participants, their caregivers, partners, and/or family members. The study follows a 2-treatment, 2-period crossover design, 2 and will consist of two 7-day study arms in random order: one bihormonal bionic pancreas arm using insulin lispro or insulin aspart and dasiglucagon, and one insulin-only bionic pancreas arm using insulin lispro or insulin aspart.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Bihormonal iLet Bionic Pancreas, Insulin-only Bionic Pancreas, Dasiglucagon
- Keywords
- bionic pancreas, closed loop, glucagon, insulin
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bihormonal iLet Bionic PancreasDevice
Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
Insulin-only Bionic PancreasDevice
Insulin-only iLet Bionic Pancreas using just insulin
DasiglucagonDrug
Experimental stable glucagon for use in the iLet Bionic Pancreas
| Study group | Role | What they receive |
|---|---|---|
| Bihormonal iLet first, then Insulin-Only iLet | Experimental | Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).
For this sequence, participants first used the bihormonal iLet bionic pancreas for 1 week. They then used the insulin-only iLet bionic pancreas for 1 week. Receives: Device: Bihormonal iLet Bionic Pancreas; Drug: Dasiglucagon |
| Insulin-Only iLet first, then Bihormonal iLet | Experimental | Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM).
For this sequence, participants first used the insulin-only iLet bionic pancreas for 1 week. They then used the bihormonal iLet bionic pancreas for 1 week. Receives: Device: Insulin-only Bionic Pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas
Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.
Measured: Days 1-7
Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available
Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.
Measured: Days 1-7
The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon
Goal for the ratio of cumulative drug doses delivered to cumulative drug doses attempted is between 0.95 and 1.05, inclusive, for insulin and, if applicable, for glucagon.
Measured: Days 1-7
Secondary outcomes (4)
Proportion of Time With CGM Glucose < 54 mg/dl
Measured: Days 2-7
Mean Continuous Glucose Monitor Glucose Concentration
Mean continuous glucose monitor glucose concentration measured days 2-7
Measured: Days 2-7
Proportion of Time Across Days 2-7 Within the CGM Glucose Range of 70-180 mg/dl
Measured: Days 2-7
Mean Grams of Carbohydrate Per Day to Treat or Prevent Hypoglycemic Events (Reported Daily by Subjects)
Measured: Days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start15 May 2019
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study follows a 2-treatment, 2-period crossover design, 2 and will consist of two 7-day study arms in random order: one bihormonal bionic pancreas arm using insulin lispro or insulin aspart and dasiglucagon, and one insulin-only bionic pancreas arm using insulin lispro or insulin aspart.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beta Bionics, Inc., Zealand Pharma
- Responsible party
- Principal investigator, Steven J. Russell, MD, PhD, Massachusetts General Hospital
- Investigators
- Steven J Russell, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840278
- Sponsor's protocol ID
- 2019P000252
- Other IDs
- 19-002
- Status last verified
- Nov 2019
- First submitted
- 11 Feb 2019
- Last updated
- 16 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Castellanos LE, Balliro CA, Sherwood JS, Jafri R, Hillard MA, Greaux E, Selagamsetty R, Zheng H, El-Khatib FH, Damiano ER, Russell SJ. Performance of the Insulin-Only iLet Bionic Pancreas and the Bihormonal iLet Using Dasiglucagon in Adults With Type 1 Diabetes in a Home-Use Setting. Diabetes Care. 2021 Jun;44(6):e118-e120. doi: 10.2337/dc20-1086. Epub 2021 Apr 27. No abstract available.
PubMed 33906916
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bihormonal iLet Bionic Pancreas Feasibility Study
- ClinicalTrials.gov ID
- NCT03840278
- Acronym / sponsor ID
- 2019P000252
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- bionic pancreas, closed loop, glucagon, insulin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Beta Bionics, Inc., Zealand Pharma
- Study start
- 15 May 2019 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 16 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes.
Detailed description
Our objective is to conduct a home-use study testing the Gen 3.2 iLet bionic pancreas system in the insulin-only configuration and the bihormonal configuration with dasiglucagion in 10 adult subjects (≥ 18 years old) with type 1 diabetes in a random-order crossover study under real-world conditions. The study will assess the safety and reliability of both iLet configurations. Our primary objective is to assess whether the iLet operates as designed comparing the insulin-only configuration of the Gen 3.2 iLet bionic pancreas system with the bihormonal configuration of the device using dasiglucagon at a concentration of 4 mg/ml. Our secondary objective is to assess the impact of both configurations of the Gen 3.2 iLet bionic pancreas system on glycemic control, quality of life, and treatment satisfaction among study participants, their caregivers, partners, and/or family members. The study follows a 2-treatment, 2-period crossover design, 2 and will consist of two 7-day study arms in random order: one bihormonal bionic pancreas arm using insulin lispro or insulin aspart and dasiglucagon, and one insulin-only bionic pancreas arm using insulin lispro or insulin aspart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study follows a 2-treatment, 2-period crossover design, 2 and will consist of two 7-day study arms in random order: one bihormonal bionic pancreas arm using insulin lispro or insulin aspart and dasiglucagon, and one insulin-only bionic pancreas arm using insulin lispro or insulin aspart.
| Arm | Type | Receives |
|---|---|---|
| Bihormonal iLet first, then Insulin-Only iLet | Experimental | Device: Bihormonal iLet Bionic Pancreas, Drug: DasiglucagonEach sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For this sequence, participants first used the bihormonal iLet bionic pancreas for 1 week. They then used the insulin-only iLet bionic pancreas for 1 week. |
| Insulin-Only iLet first, then Bihormonal iLet | Experimental | Device: Insulin-only Bionic PancreasEach sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For this sequence, participants first used the insulin-only iLet bionic pancreas for 1 week. They then used the bihormonal iLet bionic pancreas for 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years and have had clinical type 1 diabetes for at least one year
- Diabetes managed using an insulin pump for ≥ 3 months
- Prescription medication regimen stable for > 1 month (except for medications that will not affect the safety of the participant and are not expected to affect any outcome of the study, in the judgement of the principal investigator)
- Willing to wear one Dexcom CGM sensor, and up to two steel cannula infusion sets (6 mm Contact Detach) and change infusion sets frequently (if the subject is known not to tolerate steel infusion sets then a plastic set may be used)
- Have used a CGM for at least one cumulative month over the last 24 months
Key exclusion criteria (36 listed)
- Unable to provide informed consent (e.g. impaired cognition or judgment)
- Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the iLet, impaired memory, unable to speak and read English)
- Current participation in another clinical trial with administration of investigational drug.
- Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the participant
- Previous exposure to dasiglucagon (otherwise known as ZP4207)
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 |
|---|---|---|
| Bihormonal iLet Bionic PancreasBihormonal iLet Bionic Pancreas using insulin and dasiglucagon | Device | Bihormonal iLet first, then Insulin-Only iLet |
| Insulin-only Bionic PancreasInsulin-only iLet Bionic Pancreas using just insulin | Device | Insulin-Only iLet first, then Bihormonal iLet |
| DasiglucagonExperimental stable glucagon for use in the iLet Bionic Pancreas | Drug | Bihormonal iLet first, then Insulin-Only iLet |
Primary outcome
Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas
Time frame: Days 1-7
Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.
Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available
Time frame: Days 1-7
Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.
The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon
Time frame: Days 1-7
Goal for the ratio of cumulative drug doses delivered to cumulative drug doses attempted is between 0.95 and 1.05, inclusive, for insulin and, if applicable, for glucagon.
4 secondary outcomes
Proportion of Time With CGM Glucose < 54 mg/dl
Time frame: Days 2-7
Mean Continuous Glucose Monitor Glucose Concentration
Time frame: Days 2-7
Proportion of Time Across Days 2-7 Within the CGM Glucose Range of 70-180 mg/dl
Time frame: Days 2-7
Mean Grams of Carbohydrate Per Day to Treat or Prevent Hypoglycemic Events (Reported Daily by Subjects)
Time frame: Days 1-7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33906916Castellanos LE, Balliro CA, Sherwood JS, Jafri R, Hillard MA, Greaux E, Selagamsetty R, Zheng H, El-Khatib FH, Damiano ER, Russell SJ. Performance of the Insulin-Only iLet Bionic Pancreas and the Bihormonal iLet Using Dasiglucagon in Adults With Type 1 Diabetes in a Home-Use Setting. Diabetes Care. 2021 Jun;44(6):e118-e120. doi: 10.2337/dc20-1086. Epub 2021 Apr 27. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Steven J Russell, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bihormonal iLet Bionic Pancreas, Insulin-only Bionic Pancreas and Dasiglucagon in people with Type 1 Diabetes Mellitus, run by Massachusetts General Hospital at 1 site in United States.
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 36 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 16 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas (time frame: Days 1-7). 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?
On the ClinicalTrials.gov record for NCT03840278, which also lists 1 linked publication.
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 16 Dec 2019.