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This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the relationship to specific outcomes.
This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant between 2007 and 2016 to evaluate incidence and risk factors of malglycemia. The review will also aim to characterize relationships between specific outcomes and malglycemia in pediatric HSCT patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Malglycemia |
| ||
| Without Malglycemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hematopoietic Stem Cell Transplant | Procedure | Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients | hypoglycemia (BG < 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL) | Transplant Day -14 to +100 |
| Number of patients with versus without malglycemia who experience infection | It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant infections. This outcome will be assessed for differences in incidence based on malglycemia occurence | Transplant Day 0 to +100 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine whether specific exposures are associated with increased occurrence of malglycemia | The occurrence of the outcome, malglycemia, with be assessed for differences in incidence that may occur as a result of age, medication exposures (use of glucocorticoids, asparaginase, total parenteral nutrition (TPN), or calcineurin inhibitors), underlying diagnosis, and transplant type | Transplant Day -14 to +100 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who received hematopoietic stem cell transplants with the Bone Marrow Transplant Program at Children's Hospital Colorado from January 1, 2007 to July 31, 2016.
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| Name | Affiliation | Role |
|---|---|---|
| Jenna Sopfe, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36511871 | Derived | Cho S, Vigers T, Pyle L, Franklin A, Sopfe J, Jeney F, Forlenza G. Composite Metric of Glycemic Control Q-Score Is Elevated in Pediatric and Adolescent/Young Adult Hematopoietic Stem Cell Transplant Recipients. Diabetes Technol Ther. 2023 Feb;25(2):116-121. doi: 10.1089/dia.2022.0246. Epub 2022 Dec 29. | |
| 30718242 | Derived |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Survival rate of patients with versus without malglycemia | It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant mortality. This outcome will be assessed for differences in incidence based on malglycemia occurrence | Transplant Day 0 through date of relapse or death |
| Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia | It is hypothesized that patients who experience malglycemia will have an increased rate of GVHD. This outcome will be assessed for differences in incidence based on malglycemia occurrence | Transplant Day 0 through date of relapse or death |
| Sopfe J, Pyle L, Keating AK, Campbell K, Liu AK, Wadwa RP, Verneris MR, Giller RH, Forlenza GP. Malglycemia is associated with poor outcomes in pediatric and adolescent hematopoietic stem cell transplant patients. Blood Adv. 2019 Feb 12;3(3):350-359. doi: 10.1182/bloodadvances.2018021014. |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |