BridgeMD
New treatment option for Type 1 Diabetes (T1D)
Official title Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery
ClinicalTrials.gov ID: NCT07011147
What this study is testing
- What it's testing
- 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)?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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...
- Stable doses of glucose lowering medications over the preceding 4 weeks as determined by Investigator, including GLP-1 receptor agonists (GLP-1 RA)...
You likely can't join if
- Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the...
- 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...
- This would NOT include changes to any insulin doses, including pump settings, short- and/or long-acting insulin doses and type of insulin; changing...
See the full eligibility criteria
Who can 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.
- 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...
- 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 assigned by chance 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 a. Capable of becoming pregnant means that menstruation has started and...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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 \ 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...
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.