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

NCT04614623 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-11-04

No results posted yet for this study

Summary

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.

Conditions

  • Type1diabetes

Interventions

DEVICE

AHCL pump

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

OTHER

Video conferencing Application

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

Sponsors & Collaborators

  • Children's Hospital New Orleans, LA

    lead OTHER

Principal Investigators

  • Stuart A Chalew, M.D. · Children's Hospital of New Orleans/ LSUHSC Dept of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-07-30
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614623 on ClinicalTrials.gov