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ongoing concern of working with high-risk in-hospital transplant population during the various stages of the COVID-19 Pandemic.
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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
| Tandem Diabetes Care, Inc. | INDUSTRY |
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This study will be a prospective, single center, randomized controlled parallel group open-label trial. Participants with insulin requiring diabetes mellitus who have been offered an organ for living or deceased donor kidney transplantation will be recruited prior to transplantation surgery. Patients will be randomized in a 2:1 fashion to AP (6 patients) and conventional treatment groups (3 patients). At the end of the subject's post-operative in-patient stay, participants will have the option of wearing a blinded CGM at home for 4 weeks while treating themselves with multiple daily injections (MDI).
The purpose of this study is to conduct a hypothesis-generating pilot study to assess the efficacy and safety of the closed loop control in kidney transplant recipients with history of insulin requiring diabetes mellitus in the early postoperative period.
This study will be a prospective, single center, randomized controlled parallel group open-label trial. Participants with insulin requiring diabetes mellitus who have been offered an organ for living or deceased donor kidney transplantation will be recruited prior to transplantation surgery. Patients will be randomized in a 2:1 fashion to AP (6 patients) and conventional treatment groups (3 patients). At the end of the subject's post-operative in-patient stay, participants will have the option of wearing a blinded CGM at home for 12 weeks while treating themselves with multiple daily injections (MDI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Pancreas (AP) Insulin Group | Experimental |
| |
| Multiple Daily Injections (MDI) Insulin Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Pancreas | Device | The Artificial Pancreas will delivery insulin in place of Multiple Daily Injections after a kidney transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Artificial Pancreas system | Safety will be assessed by using a continuous glucose monitor, which measures interstitial glucose concentrations every 5 minutes for 24 hours a day. We will measure percentage of time in 24 hour period that the continuous glucose monitor (CGM) measures interstitial glucose values <70 mg/dL per day as a surrogate assessment of safety. | 5 Weeks |
| Efficacy of Artificial Pancreas system | Efficacy will be assessed by using a continuous glucose monitor, which measures interstitial glucose concentrations every 5 minutes, 24 hours per day. We will measure percentage of time in 24 hour period that the continuous glucose monitor (CGM) measures interstitial glucose values between 70-180 mg/dL as a surrogate assessment of efficacy. | 5 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meaghan Stumpf, MD | University of Virginia | Principal Investigator |
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Pending
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| Multiple Daily Injections | Other | Multiple Daily Injections as standard of care post kidney transplant. |
|
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007676 | Kidney Failure, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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