Diabetes Mellitus, Type 1NCT05168657
Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth
A study testing Bionic Pancreas in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
This is a study assessing the feasibility of using the insulin-only configuration of the iLet bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care practice with either in-person training and follow-up (PC-IP) or with training and follow-up via telehealth (PC-TH). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Type 1 Diabetes, Diabetes, Autoimmune
- What is being tested?
- Bionic Pancreas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2022to 23 May 2023
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years, BMI ≥ 18.5, have had clinical type 1 diabetes for at least one year, and have taken insulin for at least 1 year
- Prescription diabetes medication regimen stable for > 1 month, including any adjunctive anti-diabetic medications (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgment of the site principal investigator)
- This does not include changes to any insulin doses, including basal rates/long-acting insulin doses, carbohydrate to insulin ratios and correction factors
- Willing to wear one Dexcom CGM transmitter and sensor (sensor must be changed every 10 days), and one infusion set that must be replaced at least every 3 days.
- Endocrinology practice criterion is that diabetes is managed using sensor-augmented insulin pump therapy or artificial pancreas therapy for ≥ 3 months)
- Primary care practice criteria are that diabetes is managed by multiple daily insulin injections (insulin-pump naïve).
- TH group criterion is that participant must have hardware and internet access capable of 2-way video and audio communication
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 bionic pancreas, impaired memory)
- Unable to speak and read English, as iLet BP support materials and device menus are currently available in English only.
- Plan to change usual diabetes regimen in the next 3 months including before and during participation in the study
- This would include changing from MDI to pump or from pump to MDI, and starting a CGM if not previously used
- This would not include changes to any insulin doses, including basal rates/long acting insulin doses, carbohydrate to insulin ratios and correction factors
Show all 24Show fewer
- Current use of non-FDA approved closed-loop or hybrid closed-loop insulin delivery system (e.g. "Loop" or "Open APS")
- Unwilling to switch to lispro or aspart for the duration of the study's iLet arm (e.g. from Fiasp or Lyumjev)
- Known hemoglobinopathy (sickle cell trait is not an exclusion)
- Current participation in another diabetes-related clinical trial, has a medical condition, or use of a medication that, in the judgment of the investigator, could compromise the results of this study or the safety of the participant
- History of diabetes due to cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy
- Have a history of intermittently required glucocorticoid treatment (e.g., but not limited to, for the treatment of asthma, inflammatory bowel disease).
- A1c >11.0% (most recent value up to 1 year prior acceptable; if none available or >1 year prior, participant will be instructed to obtain A1c through their usual care provider and to make copy of result available to study team)
- History of diabetic ketoacidosis (DKA) within the past month
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
- Established history of allergy or severe reaction to adhesive or tape that must be used in the study
- Currently treated with GLP-1 analogue, thiazolidinedione (TZD), sulfonylurea, pramlintide, or SGLT-2 inhibitor medication (use more than 3 months prior to enrollment is acceptable)
- If using metformin, participants: i. Must be on a stable dose for 1 month prior to enrollment ii. Metformin can be continued while the iLet is used
- Pregnant (positive urine HCG), breast feeding, plan to become pregnant in the next 6 months, or premenopausal participants who are sexually active without use of contraception
- Renal failure on dialysis or chronic renal disease with a GFR or eGFR <30mL/min (values within the last two years will be accepted; if none available or >2 years prior, participant will be instructed to obtain GFR or eGFR through their usual care provider and to make copy of result available to study team)
- Any condition that, in the opinion of the site principal investigator, could interfere with the safe or effective completion of the study.
- Conditions to be considered by the investigator may include, but are not limited to, the following: i. Alcohol or drug abuse ii. Use of prescription drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study iii. 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 iv. Known history of prolonged QTc interval, malignant arrhythmia, or congenital heart disease v. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV vi. History of TIA or stroke in the last 12 months vii. Untreated or inadequately treated mental illness viii. History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulimia or omission of insulin to manipulate weight ix. History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
- Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
- Unable to avoid hydroxyurea for duration of study (interferes with accuracy of Dexcom G6 CGM)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Assessing Feasibility, Safety, and Efficacy of Deploying a Closed-loop Automated Insulin Delivery System by Community-based Primary Care Physicians and Academic Endocrinologists, in Person and Through Telehealth
This is a study assessing the feasibility of using the insulin-only configuration of the iLet bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care practice with either in-person training and follow-up (PC-IP) or with training and follow-up via telehealth (PC-TH). As a comparison, the iLet will be initiated by an academic endocrinology practice with either in-person training and follow-up (EN-IP) or with training and follow-up via telehealth (EN-TH).
Read the detailed description
This is a study assessing the feasibility of deploying the iLet bionic pancreas system in the insulin-only configuration to pump-naïve MDI users with type 1 diabetes, in the setting of being recruited from community-based primary care practices and being trained and managed by primary care providers (PC group), and in pump- and CGM-experienced (sensor-augmented pump or hybrid closed-loop) users with type 1 diabetes recruited from, trained, and managed by an academic endocrinology practice (EN group). In both practice settings, the exclusive use of telehealth (TH) visits will be assessed, as will the use of in-person (IP) visits. We will enroll 40 adult volunteers (≥ 18 years old) with type 1 diabetes, 20 who are insulin pump naïve MDI users enrolled from community primary care practices by University of Colorado Family Medicine (PC group) and 20 who are technology-savvy sensor-augmented pump or hybrid closed-loop users enrolled by the Massachusetts General Hospital Diabetes Clinical Research Center (EN group). Ten of the participants at each center will be trained and managed throughout the trial using in-person visits (PC-IP and EN-IP groups) and the other ten from each center will be trained and managed throughout the trial exclusively via telehealth visits (PC-TH and EN-TH groups). This will result in four study cohorts overall (endocrinology in-person, endocrinology telehealth, primary care in-person, primary care telehealth). Subjects in all four groups will each participate, in random order, in one 14-day study arm under their own usual care (UC arm) and one 14-day study arm under the insulin-only configuration of the iLet bionic pancreas (iLet arm).
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes, Diabetes, Autoimmune, Diabetes type1, Autoimmune Diabetes, Diabetes Mellitus, Brittle
- Being tested
- Bionic Pancreas, Usual Care
- Keywords
- bionic pancreas, closed loop, insulin, Pancreas, Artificial, automated insulin delivery system, t1d, t1dm
- 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.
Bionic PancreasDevice
Also called BP
14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.
Usual CareOther
Also called UC
14 days of the participant's usual care of their type 1 diabetes
| Study group | Role | What they receive |
|---|---|---|
| EN-IP-UC first, Then BP | Experimental | Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Receives: Other: Usual Care |
| EN-TH-UC first, Then BP | Experimental | Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Receives: Other: Usual Care |
| EN-IP-BP first, Then UC | Experimental | Random-order cross-over participants managed by ENDOCRINOLOGY with IN PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Receives: Device: Bionic Pancreas |
| EN-TH-BP first, Then UC | Experimental | Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Receives: Device: Bionic Pancreas |
| PC-IP-UC first, Then BP | Experimental | Random-order cross-over participants managed by PRIMARY CARE with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Receives: Other: Usual Care |
| PC-TH-UC first, Then BP | Experimental | Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Receives: Other: Usual Care |
| PC-IP-BP first, Then UC | Experimental | Random-order cross-over participants managed by PRIMARY CARE with IN PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Receives: Device: Bionic Pancreas |
| PC-TH-BP first, Then UC | Experimental | Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Receives: Device: Bionic Pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Individuals With Mean CGM Glucose <183 mg/dL (Corresponding to an Estimated HbA1c of <8.0%) on Days 3-14, by Group.
The outcome is categorical, and the primary outcome is not a direct comparison of the mean CGM glucose between the groups.
Measured: BP Arm Days 3-14
Secondary outcomes (4)
Mean CGM Glucose on Days 3-14
Individual CGM values from days 3-14 were averaged together for each participant.
Measured: BP Arm Days 3-14
Percentage of Time With CGM Glucose <54 mg/dl on Days 3-14
Calculated from all individual CGM values from days 3-14 for each participant.
Measured: BP Arm Days 3-14
Percentage of Time With CGM Glucose in the 70-180 mg/dl Range on Days 3-14
Calculated from all individual CGM values from days 3-14 for each participant.
Measured: BP Arm Days 3-14
Percentage of Individuals With Mean CGM Glucose <154 mg/dL (Corresponding to an Estimated HbA1c of <7.0%) on Days 3-14, by Group.
Calculated from all individual CGM values from days 3-14 for each participant.
Measured: BP Arm Days 3-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start31 Mar 2022
- Primary completion23 May 2023
- Study completion23 May 2023
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.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Random-order cross over trial in a home-use setting with two 14-day study arms
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Beta Bionics, Inc., Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Sean M Oser, MD, MPH, Principal investigator, University of Colorado, DenverTamara K Oser, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168657
- Sponsor's protocol ID
- 21-3272
- Status last verified
- Oct 2024
- First submitted
- 23 Nov 2021
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified glucose data and psychosocial data will be shared with research collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Feasibility, Safety, and Efficacy of Deploying a Closed-loop Automated Insulin Delivery System by Community-based Primary Care Physicians and Academic Endocrinologists, in Person and Through Telehealth
- ClinicalTrials.gov ID
- NCT05168657
- Acronym / sponsor ID
- 21-3272
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes, Diabetes, Autoimmune, Diabetes type1, Autoimmune Diabetes, Diabetes Mellitus, Brittle
- Keywords
- bionic pancreas, closed loop, insulin, Pancreas, Artificial, automated insulin delivery system, t1d, t1dm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Beta Bionics, Inc., Massachusetts General Hospital
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study assessing the feasibility of using the insulin-only configuration of the iLet bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care practice with either in-person training and follow-up (PC-IP) or with training and follow-up via telehealth (PC-TH). As a comparison, the iLet will be initiated by an academic endocrinology practice with either in-person training and follow-up (EN-IP) or with training and follow-up via telehealth (EN-TH).
Detailed description
This is a study assessing the feasibility of deploying the iLet bionic pancreas system in the insulin-only configuration to pump-naïve MDI users with type 1 diabetes, in the setting of being recruited from community-based primary care practices and being trained and managed by primary care providers (PC group), and in pump- and CGM-experienced (sensor-augmented pump or hybrid closed-loop) users with type 1 diabetes recruited from, trained, and managed by an academic endocrinology practice (EN group). In both practice settings, the exclusive use of telehealth (TH) visits will be assessed, as will the use of in-person (IP) visits. We will enroll 40 adult volunteers (≥ 18 years old) with type 1 diabetes, 20 who are insulin pump naïve MDI users enrolled from community primary care practices by University of Colorado Family Medicine (PC group) and 20 who are technology-savvy sensor-augmented pump or hybrid closed-loop users enrolled by the Massachusetts General Hospital Diabetes Clinical Research Center (EN group). Ten of the participants at each center will be trained and managed throughout the trial using in-person visits (PC-IP and EN-IP groups) and the other ten from each center will be trained and managed throughout the trial exclusively via telehealth visits (PC-TH and EN-TH groups). This will result in four study cohorts overall (endocrinology in-person, endocrinology telehealth, primary care in-person, primary care telehealth). Subjects in all four groups will each participate, in random order, in one 14-day study arm under their own usual care (UC arm) and one 14-day study arm under the insulin-only configuration of the iLet bionic pancreas (iLet arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Random-order cross over trial in a home-use setting with two 14-day study arms
| Arm | Type | Receives |
|---|---|---|
| EN-IP-UC first, Then BP | Experimental | Other: Usual CareRandom-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. |
| EN-TH-UC first, Then BP | Experimental | Other: Usual CareRandom-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. |
| EN-IP-BP first, Then UC | Experimental | Device: Bionic PancreasRandom-order cross-over participants managed by ENDOCRINOLOGY with IN PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. |
| EN-TH-BP first, Then UC | Experimental | Device: Bionic PancreasRandom-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. |
| PC-IP-UC first, Then BP | Experimental | Other: Usual CareRandom-order cross-over participants managed by PRIMARY CARE with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. |
| PC-TH-UC first, Then BP | Experimental | Other: Usual CareRandom-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. |
| PC-IP-BP first, Then UC | Experimental | Device: Bionic PancreasRandom-order cross-over participants managed by PRIMARY CARE with IN PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. |
| PC-TH-BP first, Then UC | Experimental | Device: Bionic PancreasRandom-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-85 years, BMI ≥ 18.5, have had clinical type 1 diabetes for at least one year, and have taken insulin for at least 1 year
- Willing to wear one Dexcom CGM transmitter and sensor (sensor must be changed every 10 days), and one infusion set that must be replaced at least every 3 days.
- Endocrinology practice criterion is that diabetes is managed using sensor-augmented insulin pump therapy or artificial pancreas therapy for ≥ 3 months)
- Primary care practice criteria are that diabetes is managed by multiple daily insulin injections (insulin-pump naïve).
- TH group criterion is that participant must have hardware and internet access capable of 2-way video and audio communication
Key exclusion criteria (24 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 bionic pancreas, impaired memory)
- Unable to speak and read English, as iLet BP support materials and device menus are currently available in English only.
- Plan to change usual diabetes regimen in the next 3 months including before and during participation in the study
- Current use of non-FDA approved closed-loop or hybrid closed-loop insulin delivery system (e.g. "Loop" or "Open APS")
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 |
|---|---|---|
| Bionic PancreasAlso: BP14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. | Device | EN-IP-BP first, Then UC, EN-TH-BP first, Then UC, PC-IP-BP first, Then UC, PC-TH-BP first, Then UC |
| Usual CareAlso: UC14 days of the participant's usual care of their type 1 diabetes | Other | EN-IP-UC first, Then BP, EN-TH-UC first, Then BP, PC-IP-UC first, Then BP, PC-TH-UC first, Then BP |
Primary outcome
Percentage of Individuals With Mean CGM Glucose <183 mg/dL (Corresponding to an Estimated HbA1c of <8.0%) on Days 3-14, by Group.
Time frame: BP Arm Days 3-14
The outcome is categorical, and the primary outcome is not a direct comparison of the mean CGM glucose between the groups.
4 secondary outcomes
Mean CGM Glucose on Days 3-14
Time frame: BP Arm Days 3-14
Percentage of Time With CGM Glucose <54 mg/dl on Days 3-14
Time frame: BP Arm Days 3-14
Percentage of Time With CGM Glucose in the 70-180 mg/dl Range on Days 3-14
Time frame: BP Arm Days 3-14
Percentage of Individuals With Mean CGM Glucose <154 mg/dL (Corresponding to an Estimated HbA1c of <7.0%) on Days 3-14, by Group.
Time frame: BP Arm Days 3-14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified glucose data and psychosocial data will be shared with research collaborators.
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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.
Sean M Oser, MD, MPH principal investigator
University of Colorado, Denver
Tamara K Oser, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bionic Pancreas in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by University of Colorado, Denver at 2 sites 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 7 inclusion and 24 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2024). 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 Individuals With Mean CGM Glucose <183 mg/dL (Corresponding to an Estimated HbA1c of <8.0%) on Days 3-14, by Group. (time frame: BP Arm Days 3-14). 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 21 Oct 2024.