Defining the Role of Management Factors in Outcome Disparity in Pediatric T1D

Status unconfirmed · Not applicable

Conditions studied: Type1diabetes

In brief

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\<HbA1c\<12% aged 10-17 years. The primary intervention approach will use a combination of an advanced hybrid closed loop (AHCL) pump + enhanced home video management conferencing with study CDE nurse coordinator. Information gained in the "field trial" will be used to more specifically tailor the intervention in a randomized trial. In the second part , the investigators will conduct a randomized trial of the study intervention in participants with the same clinical features as the field trial for a six month pilot period. Participants will be randomized into one of four groups. The special intervention group (AHCL+conferencing) group will be compared with a group using patient's current insulin management+followup, vs AHCL+without conferencing, vs patient's standard insulin management+conferencing. The investigators will compare HbA1c, MBG, time in glycemic range, ability to adhere with home management, satisfaction with management procedures between the groups.

Key facts

Study ID

NCT04614623

Run by

Children's Hospital New Orleans, LA

People needed

120

Starts

2020-11-01

Expected to finish

2022-12-31

Last updated by the study team

2020-11-04

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of New Orleans — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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