Diabetes Mellitus, Type 1NCT06236607
Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes
A study testing Device specific training and Study clinician/educator visit in people with Diabetes Mellitus, Type 1 and Diabetes Complications, run by Boston Medical Center at 2 sites in United States.
Trial summary
Minoritized individuals with type 1 diabetes (T1D) have approximately 2% higher average A1c levels and twice the rate of hospitalizations, complications, and mortality as their white counterparts. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Complications
- What is being tested?
- Device specific training and Study clinician/educator visit
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Feb 2025to Sep 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of T1D for at least 12 months, on MDI for at least 6 months;
- A1c ≥7.0% with no upper limit at screening (The investigator will consider the participant A1c level, compliance with current diabetes management, and prior acute diabetic complications. For this reason, there is no upper limit on A1c specified for eligibility);
- Able to understand, speak and read English (Given the language limitations in currently available pump interfaces, subjects who are not able to understand written English will not be eligible);
- Willingness to use either lispro or aspart insulin and no other insulin or new non-insulin diabetes pharmacotherapy during the study;
- Total daily dose of insulin of at least 10 units/day;
- Investigator believes that the participant will be able to successfully adhere to the study protocol.
Who cannot join
- Current use of insulin pump or closed loop insulin pump system;
- Unable to provide informed consent;
- Currently taking hydroxyurea or have medical condition that may necessitate use of hydroxyurea;
- Current use of SGLT-2 inhibitors or sulfonylureas (If using GLP-1RA, pramlintide or metformin, must be on a stable dose for 3 months prior to enrollment);
- Tape allergy or skin condition precluding use of pump or CGM;
- Females who are pregnant or intending to become pregnant (since automated algorithm adaption for some of the HCL systems used in the trial cannot be configured to adjust to changing insulin demands of pregnancy);
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- Current renal dialysis or plan to begin renal dialysis during study. Most recent eGFR <30 ml/min is exclusionary (within last 2 years is acceptable);
- Active cancer treatment;
- Extreme visual or hearing impairment that would impair ability to use CGM and pump;
- Cognitive concerns;
- Significant psychiatric diagnosis or substance abuse disorder that in the investigator's opinion impairs ability of the individual to participate.
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
Boston Medical Center
Boston, Massachusetts, 02118
Howard Wolpert, MD, 617-285-9096, howard.wolpert@bmc.org
- Recruiting
Montefiore Einstein Medical Center
The Bronx, New York, 10467
Nathalie Zavala, MPH, 718-839-7322, nathalie.zavala@einsteinmed.edu
About this study
Minoritized individuals with type 1 diabetes (T1D) have approximately 2% higher average A1c levels and twice the rate of hospitalizations, complications, and mortality as their white counterparts. However, the efficacy trials establishing the benefits of hybrid closed loop (HCL) pump therapy in T1D have been in more socially advantaged and predominantly non-Hispanic white patients. Use of this technology by individuals with T1D from underserved communities remains very low.
The investigators plan to conduct a randomized effectiveness trial - with broader eligibility criteria (including markedly elevated A1c) and longer follow up than the previous HCL efficacy trials - to evaluate the benefits, safety risks and treatment complications of HCL use in underserved adults with T1D. A comprehensive mixed-methods approach will be implemented to capture information about the user experience.
Participants will be randomized (3:1 ratio) to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy. Subjects will be followed for 9 months to collect data on effectiveness (glucose % time-in-range 70-180 mg/dL and % time < 70 mg/dL), safety (diabetic ketoacidosis and severe hypoglycemia events) and patient experience using the systems (including benefits and burdens, the impact of life stressors on HCL use, and how the match between HCL system functionality and the individual's needs and expectations impacts on user experience).
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Complications
- Being tested
- Device specific training, Study clinician/educator visit
- Keywords
- Hybrid closed loop (HCL), HCL pump therapy, Multiple daily injections (MDI), Continuous glucose monitoring (CGM), Glucose time-in-range (TIR), Glucose management indicator (GMI), Diabetic ketoacidosis, Patient reported outcomes (PRO), Ecological momentary assessment (EMA)
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Complications, Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device specific trainingDevice
Device-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs.
Study clinician/educator visitOther
Participants will receive insulin dose and other diabetes management guidance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple daily injections | Active comparator | Participants randomized into this arm will use multiple daily injections of insulin. Receives: Other: Study clinician/educator visit |
| BetaBionics iLet HCL system | Experimental | Participants randomized into this arm will use the BetaBionics iLet HCL system. Receives: Device: Device specific training |
| Insulet OP 5 HCL system | Experimental | Participants randomized into this arm will use the Insulet OP 5 HCL system. Receives: Device: Device specific training |
| Tandem Control IQ HCL system | Experimental | Participants randomized into this arm will use the Tandem Control IQ HCL system. Receives: Device: Device specific training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose time-in-range (TIR) of 70-180 mg/dL
The glucose TIR will be measured over 2 weeks using continuous glucose monitoring (CGM).
Measured: baseline, 39 weeks
Secondary outcomes (5)
Glucose time < 70 mg/dL
The glucose time <70 mg/dL will be measured over 2 weeks using continuous glucose monitoring (CGM).
Measured: baseline, 39 weeks
Glucose management indicator (GMI)
The GMI will be measured using continuous glucose monitoring (CGM).
Measured: baseline, 39 weeks
A1C
A hemoglobin A1C test is a blood test that measures a person's average blood glucose level over the previous three months.
Measured: baseline, 39 weeks
Body weight
Participants' body weight will be measured and recorded.
Measured: baseline, 39 weeks
Diabetic Ketoacidosis events
Events of diabetic ketoacidosis with be abstracted electronic and medical record review and from patient report.
Measured: baseline, 39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start27 Feb 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial will have a four-arm, parallel group design, with 9-month intervention phase. Adults with T1D on MDI therapy will be randomized in a 1:1:1:1 ratio to receive either: 1) BetaBionics iLet HCL system; 2) Insulet OP 5 HCL system; 3) Tandem Control IQ HCL system, or 4) Continued MDI. All trial participants will use CGM, Block randomization, within strata defined by A1c (\> vs ≤ 9%), using blocks of sizes 4 and 6, randomly permuted will be done. The groups are expected to have \>20% participants screening A1c \>9%.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Wolpert, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236607
- Sponsor's protocol ID
- H-44351
- Other IDs
- 1R01DK138309-01
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06236607
- Acronym / sponsor ID
- H-44351
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Complications
- Keywords
- Hybrid closed loop (HCL), HCL pump therapy, Multiple daily injections (MDI), Continuous glucose monitoring (CGM), Glucose time-in-range (TIR), Glucose management indicator (GMI), Diabetic ketoacidosis, Patient reported outcomes (PRO)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 1 Feb 2024 (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.
Minoritized individuals with type 1 diabetes (T1D) have approximately 2% higher average A1c levels and twice the rate of hospitalizations, complications, and mortality as their white counterparts. However, the efficacy trials establishing the benefits of hybrid closed loop (HCL) pump therapy in T1D have been in more socially advantaged and predominantly non-Hispanic white patients. Use of this technology by individuals with T1D from underserved communities remains very low.
The investigators plan to conduct a randomized effectiveness trial - with broader eligibility criteria (including markedly elevated A1c) and longer follow up than the previous HCL efficacy trials - to evaluate the benefits, safety risks and treatment complications of HCL use in underserved adults with T1D. A comprehensive mixed-methods approach will be implemented to capture information about the user experience.
Participants will be randomized (3:1 ratio) to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy. Subjects will be followed for 9 months to collect data on effectiveness (glucose % time-in-range 70-180 mg/dL and % time < 70 mg/dL), safety (diabetic ketoacidosis and severe hypoglycemia events) and patient experience using the systems (including benefits and burdens, the impact of life stressors on HCL use, and how the match between HCL system functionality and the individual's needs and expectations impacts on user experience).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The trial will have a four-arm, parallel group design, with 9-month intervention phase. Adults with T1D on MDI therapy will be randomized in a 1:1:1:1 ratio to receive either: 1) BetaBionics iLet HCL system; 2) Insulet OP 5 HCL system; 3) Tandem Control IQ HCL system, or 4) Continued MDI. All trial participants will use CGM, Block randomization, within strata defined by A1c (> vs ≤ 9%), using blocks of sizes 4 and 6, randomly permuted will be done. The groups are expected to have >20% participants screening A1c >9%.
| Arm | Type | Receives |
|---|---|---|
| Multiple daily injections | Active comparator | Other: Study clinician/educator visitParticipants randomized into this arm will use multiple daily injections of insulin. |
| BetaBionics iLet HCL system | Experimental | Device: Device specific trainingParticipants randomized into this arm will use the BetaBionics iLet HCL system. |
| Insulet OP 5 HCL system | Experimental | Device: Device specific trainingParticipants randomized into this arm will use the Insulet OP 5 HCL system. |
| Tandem Control IQ HCL system | Experimental | Device: Device specific trainingParticipants randomized into this arm will use the Tandem Control IQ HCL system. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of T1D for at least 12 months, on MDI for at least 6 months;
- A1c ≥7.0% with no upper limit at screening (The investigator will consider the participant A1c level, compliance with current diabetes management, and prior acute diabetic complications. For this reason, there is no upper limit on A1c specified for eligibility);
- Able to understand, speak and read English (Given the language limitations in currently available pump interfaces, subjects who are not able to understand written English will not be eligible);
- Willingness to use either lispro or aspart insulin and no other insulin or new non-insulin diabetes pharmacotherapy during the study;
- Total daily dose of insulin of at least 10 units/day;
Key exclusion criteria (11 listed)
- Current use of insulin pump or closed loop insulin pump system;
- Unable to provide informed consent;
- Currently taking hydroxyurea or have medical condition that may necessitate use of hydroxyurea;
- Current use of SGLT-2 inhibitors or sulfonylureas (If using GLP-1RA, pramlintide or metformin, must be on a stable dose for 3 months prior to enrollment);
- Tape allergy or skin condition precluding use of pump or CGM;
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 |
|---|---|---|
| Device specific trainingDevice-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs. | Device | BetaBionics iLet HCL system, Insulet OP 5 HCL system, Tandem Control IQ HCL system |
| Study clinician/educator visitParticipants will receive insulin dose and other diabetes management guidance. | Other | Multiple daily injections |
Primary outcome
Glucose time-in-range (TIR) of 70-180 mg/dL
Time frame: baseline, 39 weeks
The glucose TIR will be measured over 2 weeks using continuous glucose monitoring (CGM).
5 secondary outcomes
Glucose time < 70 mg/dL
Time frame: baseline, 39 weeks
Glucose management indicator (GMI)
Time frame: baseline, 39 weeks
A1C
Time frame: baseline, 39 weeks
Body weight
Time frame: baseline, 39 weeks
Diabetic Ketoacidosis events
Time frame: baseline, 39 weeks
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 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Howard Wolpert, MD principal investigator
Boston Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device specific training and Study clinician/educator visit in people with Diabetes Mellitus, Type 1 and Diabetes Complications, run by Boston Medical Center 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 6 inclusion and 11 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 1 Apr 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 Howard Wolpert, MD (617-285-9096, howard.wolpert@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose time-in-range (TIR) of 70-180 mg/dL (time frame: baseline, 39 weeks). 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 1 Apr 2026.