Defining the Role of Management Factors in Outcome Disparity in Pediatric T1D
Type1diabetes
About this trial
This is an interventional treatment trial for Type1diabetes focused on measuring type1diabetes, health disparity, pediatrics, advanced hydbrid closed loop insulin pump, youth, HbA1c, teleconferencing, racial disparity, continuous glucose monitoring
Eligibility Criteria
Inclusion Criteria:
T1D as defined by:
- Typical clinical presentation at diagnosis
- Prior documentation of one or more anti-pancreatic antibodies
- Requiring >0.3 units/kg/d insulin therapy
- On no oral hypoglycemic agents concurrently
- Body mass index (BMI) <90% for age and gender
- 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:
- Unwillingness or inability to be randomized and/or participate in study procedures
- Pregnancy/plans to become pregnant/immediate post pregnancy and breast feeding
- Smoking, alcohol use, illicit drug use
- Severe psychiatric illness of patient or parent/guardian
- More than one (1) episode of diabetic ketoacidosis (DKA) in the past year
- Inability to wear sensor and/or pump catheter
- Known allergy to medical adhesives
- Less than two (2) clinic visits in the past year
- Absence of anti-pancreatic antibodies at diagnosis
- BMI ≥90%
- Hypoglycemic unawareness associated with severe episodes of hypoglycemia
- Insulin requirement <0.3 units/kg/d
- On hypoglycemic agent besides insulin within prior 6 months or other medication which in the judgment of the investigator may be a contraindication to participation in the study.
- Other chronic illness or condition besides diabetes (exception for hypothyroidism if stable on thyroxine replacement therapy) that would interfere in patient or family's participation in the study, or would influence metabolic control or HbA1c interpretation
- Inability to participate in "run-in" pre-randomization activities for randomized trial
Sites / Locations
- Children's Hospital of New Orleans
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
Current Diabetes Management Continued
Video Conferencing+Current Insulin Delivery
AHCL pump without Video Conferencing
AHCL pump+Video Conferencing
Continued Insulin Delivery Method and Current Clinic Care of Diabetes
Patients continue current insulin delivery modality but receive enhanced clinical management support via video conferencing link by diabetes coordinator
Patients switch to use of an Advanced Hybrid Closed Loop pump without Video Conferencing standard support
Patients will use Advanced Hybrid Closed Loop pump with enhanced clinical support via video conferencing