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

October 28, 2020 updated by: Stuart Chalew, Children's Hospital New Orleans, LA

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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<HbA1c<12%, age 10-17 years. The field trial will be for a 4 week period. THe investigators will use feedback and experience during the "field trial" from patients, parents and the study coordinator to refine the intervention and reduce patient problems with the technology, enhance its effectiveness improve participant adherence to management. This information will help guide/refine the design and use of the technologies in a randomized intervention trial (Part 2). Participants may choose to continue using the technologies after the initial 4 week Field Trial period for up to 6 months. AHCL must be returned at the end of participation.

Part 2: The investigators will conduct a randomized intervention trial in a factorial four group design comparing outcome measures in participants assigned to the combined AHCL+conferencing, versus use of AHCL or conferencing alone versus usual care. Basic inclusion criterion will be self-identification as African American ethnicity, having T1D, 8.5<HbA1c<12%, age 10-17 years. Outcome measures will be assessed at 3 and 6 month study visits. The major outcome metric will be HbA1c. In addition mean blood glucose (MBG), time in range, frequency of hyper/hypoglycemia, quality of life and treatment satisfaction will be compared between groups, Participation will be concluded at the 6 month visit. AHCL must be returned at the end of participation.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Current Diabetes Management Continued
Continued Insulin Delivery Method and Current Clinic Care of Diabetes
Experimental: Video Conferencing+Current Insulin Delivery
Patients continue current insulin delivery modality but receive enhanced clinical management support via video conferencing link by diabetes coordinator
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
Experimental: AHCL pump without Video Conferencing
Patients switch to use of an Advanced Hybrid Closed Loop pump without Video Conferencing standard support
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
Experimental: AHCL pump+Video Conferencing
Patients will use Advanced Hybrid Closed Loop pump with enhanced clinical support via video conferencing
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c) Change From Baseline to 6 months (End of study)
Time Frame: Change in HbA1c will be assessed from baseline to the HbA1c at 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean blood glucose (MBG) Change From Baseline to 6 months (End of study)
Time Frame: Change in MBG will be assessed at baseline and compared with 6 month measure (study end)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Glucose Range Change From Baseline to 6 months (End of study)
Time Frame: Cnge in Percent of Time in and out of glucose range at Baseline will be compared with 6 month measurement (study end)
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)
Time Frame: Assessment of Change: Baseline will be compared with 6 month measure (study end)
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)
Time Frame: Assessment of Change: Baseline compared with 6 month measure (study end)
Pediatric Quality of Life Scale
Assessment of Change: Baseline compared with 6 month measure (study end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital New Orleans, LA

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

July 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21DK118643 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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