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Type 1 diabetes (T1D), is associated with considerable risk of morbidity and mortality due to chronic hyperglycemia. Despite innovations in management, pediatric patients of African ancestry (AA) have been found to have persistently higher mean blood glucose (MBG) than European ancestry (EA) patients. The investigators hypothesize that an intervention using advanced insulin delivery technology together with home management will sustainably improve MBG to levels comparable to EA patients without increasing hypoglycemia.
The investigators will first perform a small "field trial" of the intervention in African American patients having T1D, with 8.5\
Type 1 diabetes (T1D), one of the most prevalent incurable diseases of childhood, is associated with serious risk of morbidity and mortality due to the development of micro- and macrovascular complications. Complications can be prevented by treatment that achieves physiological or near physiological levels of glucose. Despite innovations in management over the past three decades, pediatric patients of African ancestry (AA) have had persistently higher HbA1c than patients of white, European ancestry (EA). Higher HbA1c in AA patients is associated with both higher acute and chronic morbidity and mortality compared to EA patients. Thus, racial disparity in glycemic outcome and the development of complications is a major unresolved challenge of current clinical pediatric diabetes treatment.
Multiple factors contribute to high-risk levels of mean blood glucose (MBG) in pediatric AA patients compared to EA. AA patients have less access to insulin pumps, perform glucose testing less often, have less contact with diabetes management staff, and may have difficulty relating to management staff due to cultural and socioeconomic differences. Greater occurrence of hypoglycemia is another obstacle to achieving optimal glucose control. These considerations have led us to hypothesize that an intervention targeting this group of major management obstacles will sustainably reduce MBG to levels comparable to EA patients without increased hypoglycemia. The investigators propose that an advanced hybrid closed loop (AHCL) pump system combined with frequent enhanced home video management conferencing (TECH) with the study CDE nurse coordinator will facilitate improvement of MBG and HbA1c, increase time in glycemic goal range, have minimal occurrence of hypoglycemia, and improve patient satisfaction with management.
Part 1: The investigators will first pre-test the intervention approach in ten participants using a combination of an advanced hybrid closed loop (AHCL) pump system + home video conferences with the study CDE nurse coordinator to enhance home management. Basic inclusion criterion will be self-identification as African American ethnicity, having T1D, 8.5\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current Diabetes Management Continued | No Intervention | Continued Insulin Delivery Method and Current Clinic Care of Diabetes | |
| Video Conferencing+Current Insulin Delivery | Experimental | Patients continue current insulin delivery modality but receive enhanced clinical management support via video conferencing link by diabetes coordinator |
|
| AHCL pump without Video Conferencing | Experimental | Patients switch to use of an Advanced Hybrid Closed Loop pump without Video Conferencing standard support |
|
| AHCL pump+Video Conferencing | Experimental | Patients will use Advanced Hybrid Closed Loop pump with enhanced clinical support via video conferencing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHCL pump | Device | Advanced Hybrid Closed Loop (AHCL) pump automatically adjusts insulin infusion rate of pump customized to patient's needs to reduce occurrence of hypo and hyperglycemia |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) Change From Baseline to 6 months (End of study) | Hemoglobin A1c (Glycated hemoglobin) | Change in HbA1c will be assessed from baseline to the HbA1c at 6 months (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean blood glucose (MBG) Change From Baseline to 6 months (End of study) | Mean glucose levels as estimated from recorded glucose meter and sensor data | Change in MBG will be assessed at baseline and compared with 6 month measure (study end) |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Glucose Range Change From Baseline to 6 months (End of study) | Percent Time Spent in Hyper/Hypo and Goal glucose ranges during the study | Cnge in Percent of Time in and out of glucose range at Baseline will be compared with 6 month measurement (study end) |
| DSMP-SR Change from Baseline to 6 months (End of Study) |
Inclusion Criteria:
T1D as defined by:
T1D duration of ≥ 6 months
Self-identification as of African ancestry (AA)
Age 10-17 years inclusive
Pre-recruitment HbA1c 8.6-12%
Glucose meter MBG ≥ 200 mg/dL
Have smartphone/tablet/computer for conferencing
Willingness to download and use the app for conferencing
Willingness to be randomized to one of the clinical arms of the study (for Randomized intervention trial)
Willingness and ability to wear pump and sensor, maintain equipment, and upload data from the system
In stable living environment with a parent or guardian trained and able to recognize and intervene in diabetes emergency such as DKA or hypoglycemia
Willingness to attend clinic visits during study at 3 and 6 month intervals
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stuart A Chalew, M.D. | Contact | 504 896 9441 | schale@lsuhsc.edu | |
| Sonja Washington, R.N. | Contact | 504 896 9441 | sonja.washington@lcmchealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Stuart A Chalew, M.D. | Children's Hospital of New Orleans/ LSUHSC Dept of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of New Orleans | New Orleans | Louisiana | 70118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| Video conferencing Application | Other | Video conferencing application will be used to enhance communication between participant and parent with the study certified diabetes educator (CDE) nurse coordinator. These individualized sessions will be designed to help the family with solving diabetes management problems to enhance glycemic control |
|
Diabetes Self-Management Profile |
| Assessment of Change: Baseline will be compared with 6 month measure (study end) |
| PedsQL-Diabetes Module Change from Baseline to 6 months (study end) | Pediatric Quality of Life Scale | Assessment of Change: Baseline compared with 6 month measure (study end) |
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