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

NCT04614623 | Unknown DMC FDA Device

• 1 other identifier: R21DK118643
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

type1diabetes; health disparity; pediatrics; advanced hydbrid closed loop insulin pump; youth; HbA1c; teleconferencing; racial disparity; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Mean blood glucose (MBG) Change From Baseline to 6 months (End of study)

  Change in MBG will be assessed at baseline and compared with 6 month measure (study end)

Other Outcomes (3)

• Time in Glucose Range Change From Baseline to 6 months (End of 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)

  Assessment of Change: Baseline will be compared with 6 month measure (study end)

• PedsQL-Diabetes Module Change from Baseline to 6 months (study end)

  Assessment of Change: Baseline compared with 6 month measure (study end)

Study Arms (4)

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

Other: Video conferencing Application

AHCL pump without Video Conferencing

EXPERIMENTAL

Patients switch to use of an Advanced Hybrid Closed Loop pump without Video Conferencing standard support

Device: AHCL pump

AHCL pump+Video Conferencing

EXPERIMENTAL

Patients will use Advanced Hybrid Closed Loop pump with enhanced clinical support via video conferencing

Device: AHCL pump; Other: Video conferencing Application

Interventions

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

AHCL pump without Video Conferencing; AHCL pump+Video Conferencing

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

AHCL pump+Video Conferencing; Video Conferencing+Current Insulin Delivery

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

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

Sponsors & Collaborators

• Children's Hospital New Orleans, LA: lead

Study Sites (1)

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118, United States

Location

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Study Officials

• Stuart A Chalew, M.D.

  Children's Hospital of New Orleans/ LSUHSC Dept of Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart A Chalew, M.D.

CONTACT

504 896 9441; schale@lsuhsc.edu

Sonja Washington, R.N.

CONTACT

504 896 9441; sonja.washington@lcmchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Director Pediatric Endocrine/Diabetes

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: November 4, 2020
• Study Start: November 1, 2020
• Primary Completion: July 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 4, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)