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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK138309-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple daily injections | Active Comparator | Participants randomized into this arm will use multiple daily injections of insulin. |
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| BetaBionics iLet HCL system | Experimental | Participants randomized into this arm will use the BetaBionics iLet HCL system. |
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| Insulet OP 5 HCL system | Experimental | Participants randomized into this arm will use the Insulet OP 5 HCL system. |
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| Tandem Control IQ HCL system | Experimental | Participants randomized into this arm will use the Tandem Control IQ HCL system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device specific training | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose time-in-range (TIR) of 70-180 mg/dL | The glucose TIR will be measured over 2 weeks using continuous glucose monitoring (CGM). | baseline, 39 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose time < 70 mg/dL | The glucose time <70 mg/dL will be measured over 2 weeks using continuous glucose monitoring (CGM). | baseline, 39 weeks |
| Glucose management indicator (GMI) | The GMI will be measured using continuous glucose monitoring (CGM). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Howard Wolpert, MD | Contact | 617-285-9096 | howard.wolpert@bmc.org | |
| Astrid Atakov Castillo, BA | Contact | 617-638-5906 | Astrid.AtakovCastillo@bmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Howard Wolpert, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D048909 | Diabetes Complications |
| D016883 | Diabetic Ketoacidosis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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%.
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| Study clinician/educator visit | Other | Participants will receive insulin dose and other diabetes management guidance. |
|
| 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. | baseline, 39 weeks |
| Body weight | Participants' body weight will be measured and recorded. | baseline, 39 weeks |
| Diabetic Ketoacidosis events | Events of diabetic ketoacidosis with be abstracted electronic and medical record review and from patient report. | baseline, 39 weeks |
| Montefiore Einstein Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |