Type 1 Diabetes (T1D)PREPARE 4 AIDNCT07011147
Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery
A study testing Bionic Pancreas and Routine Care in people with Type 1 Diabetes (T1D) and Type 2 Diabetes, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Type 2 Diabetes, Diabetes, Autoimmune
- What is being tested?
- Bionic Pancreas and Routine Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jan 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at time of consent >18 and <89 years
- Either 2.a. or 2.b.:
- Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year
- Clinical diagnosis of type 2 diabetes, on current injected or infused insulin regimen for at least 3 months prior to screening (e.g., basal-bolus, basal only, or pre-mix)
- Stable doses of glucose lowering medications over the preceding 4 weeks as determined by Investigator, including GLP-1 receptor agonists (GLP-1 RA) and GLP-1/GIP RA agents
- Stable doses of weight loss medications (including GLP-1 RA and GLP-1/GIP RA agents) over the preceding 4 weeks as determined by the investigator.
Show all 22Show fewer
- For those using the iLet Bionic Pancreas (during the RCT arm or observational extension phase), willingness to stay on current doses of medications throughout the study that may affect glycemia directly and/or indirectly, except for a dose reduction or discontinuation.
- Have a primary care clinician willing to refer them to the study, confirm their diabetes diagnosis (for example: type 1 diabetes or type 2 diabetes), and recommend and manage the iLet for the duration of the study
- Willing to comply with all study procedures for the duration of the study
- Willing to wear a Dexcom CGM device and iLet system for duration of time randomized to iLet use or OEP
- Willing to use the following insulin: lispro (including non-branded lispro and Humalog) or aspart (including non-branded aspart, Fiasp, and Novolog)
- Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
- Willing and able to sign and date the Informed Consent Form (ICF)
- If capable of becoming pregnant, willing and able to have pregnancy testing and use an acceptable method of contraception during the study period
- Capable of becoming pregnant means that menstruation has started and the participant is not surgically sterile or post-menopausal (12 months without menses) b. Acceptable methods of contraception include: i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
- Placement of an intrauterine device or intrauterine hormone-releasing system.
- Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository).
- Has a vasectomized or sterile partner (where partner is sole partner of participant) and where vasectomy has been confirmed by medical assessment.
- Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study.
- Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration
- Have hardware and internet access capable of 2-way video and audio communication
Who cannot join
- 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
- Diagnosis of maturity-onset diabetes of the young (MODY)
- Plan to change usual diabetes regimen between screening and study randomization
- This would include changing from MDI to pump or from pump to MDI, starting a new class of type 2 diabetes medication, or starting or increasing GLP-1 RA or GLP-1/GIP RA medication
- This would NOT include changes to any insulin doses, including pump settings, short- and/or long-acting insulin doses and type of insulin; changing type 2 diabetes medication dosing (except GLP-1 RA or GLP-1/GIP RA); or changing type of type 2 diabetes medication within the same class
Show all 26Show fewer
- Weigh more than 255 kg (561 pounds) as this is the maximum weight that can be entered into the iLet user interface
- History of bariatric surgery within 12 months prior to enrollment or plans for bariatric surgery within the period of study participation
- Current use of a closed-loop or hybrid closed-loop insulin delivery system that is not FDA-cleared (e.g. "DIY Loop", "AAPS", "iAPS" or "Open APS")
- Diagnosed blood disorder or dyscrasia associated with hemolysis, including for example: sickle cell disease and thalassemia, which in the Investigator's opinion could interfere with HbA1c accuracy
- Planned use of hydroxyurea at any dose and/or of acetaminophen at doses exceeding 1 gram (1000 mg) every 6 hours.
- Plans to receive a blood transfusion over the course of the study or has received a transfusion within 3 months prior to enrollment
- Current participation in another diabetes-related clinical trial
- 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 intermittent oral or injectable glucocorticoid treatment within 8 weeks prior to screening or plans to take intermittent oral or injectable glucocorticoid during the study (chronic, stable treatment is acceptable, unplanned use is acceptable)
- History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) in the 6 months prior to screening, unrelated to an intercurrent illness or to a kinked, dislodged, or occluded cannula
- Established history of allergy or severe reaction to adhesive or tape that must be used in the study
- Treated currently or within the past 30 days prior to enrollment, or plan to begin treatment, with sulfonylurea, pramlintide, or SGLT-2 inhibitor medication
- Any planned surgery during the study that would be considered major in the opinion of the investigator
- Pregnant or lactating, or planning to become pregnant in the next 6 months
- 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 or circumstance that, in the opinion of the site principal investigator, could interfere with the safe or effective completion of the study or which could compromise the results of the study c. Conditions to be considered by the investigator may include, but are not limited to, the following: i. Active clinical diagnosis of substance use disorder ii. Chronic use of opiates and/or benzodiazepines which, in the opinion of the investigator, might make it difficult for the participant to follow study procedures 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 severe 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 untreated or inadequately treated 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
- Plans to travel outside of the US and its territories for more than four weeks consecutively
- Plans not to have internet/video/phone access for more than one week consecutively
- 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
- Previous use of the iLet for more than four weeks (including use of the commercially available iLet or prior participation in a study involving wearing the iLet for more than four weeks)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Jessica Parascando, MPH, 303-724-9525 ext. x49525, jessica.parascando@cuanschutz.edu
Elizabeth Westfeldt, BSN, RN, 303-724-9525 ext. x49525, elizabeth.westfeldt@cuanschutz.edu
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Amy Sabean, RN, ASABEAN@mgh.harvard.edu
Melissa Putman, MD
About this study
The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is:
Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)?
Read more
Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care.
Participants will:
Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks
- Conditions
- Type 1 Diabetes (T1D), Type 2 Diabetes, Diabetes, Autoimmune, Diabetes Mellitus, Diabetes Mellitus Type 2, Diabetes Mellitus, Type I
- Being tested
- Bionic Pancreas, Routine Care
- Keywords
- automated insulin delivery, type 1 diabetes, type 2 diabetes, bionic pancreas, closed loop, pancreas, artificial, t1d, t2d, diabetes, insulin, primary care
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bionic PancreasDevice
The intervention group will use the iLet Bionic Pancreas (BP) for 13-weeks. They will be trained on the iLet BP system and its components by a Certified iLet Trainer. They will also be trained on how to use the study continuous glucose monitor (CGM) system, blood glucose meter, and ketone meter. Participants will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events and device issues. At the end of 13-weeks, they will complete final visit tasks and will be transitioned back to their pre-study insulin delivery method with guidance provided by a study investigator.
Routine CareOther
Participants will continue with their current diabetes treatment. Participants will be trained on the use of the study blood glucose meter. They will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events. At the end of 13-weeks, they will complete final visit tasks and will be asked if they would like to participate in the observational extension phase where they will use the iLet Bionic Pancreas for 13 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bionic Pancreas | Experimental | Not described Receives: Device: Bionic Pancreas |
| Routine Care | Active comparator | Not described Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c between the BP and RC groups
Superiority testing for HbA1c at 13 weeks between the BP and RC groups using linear mixed effects regression models adjusting for baseline HbA1c.
Measured: RCT Week 13
Percentage of Time With CGM Glucose <54 mg/dl
Non-inferiority testing for ordinal TBR<54mg/dL will be determined using a two-sided 95% confidence interval on the mean difference in % time <54 mg/dL between BP and RC groups using a linear mixed effects regression model adjusting for baseline % time <54 mg/dL, diabetes type, and clinical center.
Measured: RCT Weeks 1-13 and OEP Weeks 13-26
Secondary outcomes (9)
Percentage of Time With CGM Glucose in the 70-180 mg/dl Range
Calculated from all individual CGM values from RCT weeks 1-13 for each participant.
Measured: RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time in Tight Range With CGM Glucose in the 70-140 mg/dl
Calculated from all individual CGM values from weeks 1-13 for each participant.
Measured: RCT Weeks 1-13 and OEP Weeks 13-26
Mean CGM Glucose
Individual CGM values from weeks 1-13 averaged together for each participant.
Measured: RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time With CGM Glucose >250 mg/dl Range
Calculated from all individual CGM values from weeks 1-13 for each participant.
Measured: RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time With CGM Glucose >180 mg/dl Range
Calculated from all individual CGM values from weeks 1-13 for each participant.
Measured: RCT Weeks 1-13 and OEP Weeks 13-26
Standard deviation of CGM glucose
Calculated from mean CGM values from weeks 1-13 for each participant.
Measured: RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time With CGM Glucose Below <70 mg/dl Range
Calculated from all individual CGM values from weeks 1-13 for each participant.
Measured: RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time With CGM Glucose Below <54 mg/dl Range
Calculated from all individual CGM values from weeks 1-13 for each participant.
Measured: RCT Weeks 1-13 and OEP Weeks 13-26
Coefficient of variation of CGM glucose
Calculated from mean CGM values from weeks 1-13 for each participant.
Measured: RCT Weeks 1-13 and OEP Weeks 13-26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start16 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies 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
- Randomised
- Intervention model
- Crossover
- Model description
- 13-week randomized controlled trial with optional 13-week extension phase
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Beta Bionics, Inc., Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Sponsor
- Investigators
- Sean Oser, MD, MPH, CDCES, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011147
- Sponsor's protocol ID
- 24-0810
- Other IDs
- G-2312-06449
- Acronym
- PREPARE 4 AID
- Status last verified
- Apr 2026
- First submitted
- 30 May 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery
- ClinicalTrials.gov ID
- NCT07011147
- Acronym / sponsor ID
- PREPARE 4 AID / 24-0810
- Conditions
- Type 1 Diabetes (T1D), Type 2 Diabetes, Diabetes, Autoimmune, Diabetes Mellitus, Diabetes Mellitus Type 2, Diabetes Mellitus, Type I
- Keywords
- automated insulin delivery, type 1 diabetes, type 2 diabetes, bionic pancreas, closed loop, pancreas, artificial, t1d, t2d
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beta Bionics, Inc., Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 8 Jun 2025 (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 goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is:
Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)?
Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care.
Participants will:
Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 13-week randomized controlled trial with optional 13-week extension phase
| Arm | Type | Receives |
|---|---|---|
| Bionic Pancreas | Experimental | Device: Bionic Pancreas |
| Routine Care | Active comparator | Other: Routine Care |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age at time of consent >18 and <89 years
- Either 2.a. or 2.b.:
- Stable doses of glucose lowering medications over the preceding 4 weeks as determined by Investigator, including GLP-1 receptor agonists (GLP-1 RA) and GLP-1/GIP RA agents
- Stable doses of weight loss medications (including GLP-1 RA and GLP-1/GIP RA agents) over the preceding 4 weeks as determined by the investigator.
- For those using the iLet Bionic Pancreas (during the RCT arm or observational extension phase), willingness to stay on current doses of medications throughout the study that may affect glycemia directly and/or indirectly, except for a dose reduction or discontinuation.
Key exclusion criteria (26 listed)
- 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
- Diagnosis of maturity-onset diabetes of the young (MODY)
- Plan to change usual diabetes regimen between screening and study randomization
- Weigh more than 255 kg (561 pounds) as this is the maximum weight that can be entered into the iLet user interface
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 PancreasThe intervention group will use the iLet Bionic Pancreas (BP) for 13-weeks. They will be trained on the iLet BP system and its components by a Certified iLet Trainer. They will also be trained on how to use the study continuous glucose monitor (CGM) system, blood glucose meter, and ketone meter. Participants will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events and device issues. At the end of 13-weeks, they will complete final visit tasks and will be transitioned back to their pre-study insulin delivery method with guidance provided by a study investigator. | Device | Bionic Pancreas |
| Routine CareParticipants will continue with their current diabetes treatment. Participants will be trained on the use of the study blood glucose meter. They will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events. At the end of 13-weeks, they will complete final visit tasks and will be asked if they would like to participate in the observational extension phase where they will use the iLet Bionic Pancreas for 13 weeks. | Other | Routine Care |
Primary outcome
HbA1c between the BP and RC groups
Time frame: RCT Week 13
Superiority testing for HbA1c at 13 weeks between the BP and RC groups using linear mixed effects regression models adjusting for baseline HbA1c.
Percentage of Time With CGM Glucose <54 mg/dl
Time frame: RCT Weeks 1-13 and OEP Weeks 13-26
Non-inferiority testing for ordinal TBR<54mg/dL will be determined using a two-sided 95% confidence interval on the mean difference in % time <54 mg/dL between BP and RC groups using a linear mixed effects regression model adjusting for baseline % time <54 mg/dL, diabetes type, and clinical center.
9 secondary outcomes
Percentage of Time With CGM Glucose in the 70-180 mg/dl Range
Time frame: RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time in Tight Range With CGM Glucose in the 70-140 mg/dl
Time frame: RCT Weeks 1-13 and OEP Weeks 13-26
Mean CGM Glucose
Time frame: RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time With CGM Glucose >250 mg/dl Range
Time frame: RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time With CGM Glucose >180 mg/dl Range
Time frame: RCT Weeks 1-13 and OEP Weeks 13-26
Standard deviation of CGM glucose
Time frame: RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time With CGM Glucose Below <70 mg/dl Range
Time frame: RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time With CGM Glucose Below <54 mg/dl Range
Time frame: RCT Weeks 1-13 and OEP Weeks 13-26
Coefficient of variation of CGM glucose
Time frame: RCT Weeks 1-13 and OEP Weeks 13-26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified glucose data and psychosocial data will be shared with research collaborators.
Related trials for Type 1 Diabetes (T1D)
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
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.
Sean Oser, MD, MPH, CDCES 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 and Routine Care in people with Type 1 Diabetes (T1D) and Type 2 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 22 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Parascando, MPH (303-724-9525 ext. x49525, primarycarediabeteslab@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c between the BP and RC groups (time frame: RCT Week 13). The study lists 2 primary outcomes in all. 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 11 Jun 2026.