Clinical trial NCT04614623: Defining the Role of Management Factors in Outcome Disparity in Pediatric T1D
Official title: Defining the Role of Management Factors in Outcome Disparity in Pediatric T1D
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type1diabetes
Keywords: type1diabetes
health disparity
pediatrics
advanced hydbrid closed loop insulin pump
youth
HbA1c
teleconferencing
racial disparity
continuous glucose monitoring
Lead sponsor: Children's Hospital New Orleans, LA
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Hemoglobin A1c (HbA1c) Change From Baseline to 6 months (End of study)
timeFrame: Change in HbA1c will be assessed from baseline to the HbA1c at 6 months (end of study)
Secondary outcomes:
measure: Mean blood glucose (MBG) Change From Baseline to 6 months (End of study)
timeFrame: Change in MBG will be assessed at baseline and compared with 6 month measure (study end)
Other outcomes:
measure: Time in Glucose Range Change From Baseline to 6 months (End of study)
timeFrame: Cnge in Percent of Time in and out of glucose range at Baseline will be compared with 6 month measurement (study end)
measure: DSMP-SR Change from Baseline to 6 months (End of Study)
timeFrame: Assessment of Change: Baseline will be compared with 6 month measure (study end)
measure: PedsQL-Diabetes Module Change from Baseline to 6 months (study end)
timeFrame: Assessment of Change: Baseline compared with 6 month measure (study end)
Locations:
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans
state: Louisiana
Study officials:
affiliation: Children's Hospital of New Orleans/ LSUHSC Dept of Pediatrics
name: Stuart A Chalew, M.D.
role: PRINCIPAL_INVESTIGATOR
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