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

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04614623
• Other study ID #: R21DK118643
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2020
• Source: Children's Hospital New Orleans, LA
• Contact: Stuart A Chalew, M.D.
• Phone: 504 896 9441
• Email: schale[@]lsuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of New Orleans	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital New Orleans, LA

Country where clinical trial is conducted

United States, 

References & Publications (60)

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* Note: There are 60 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time in Glucose Range Change From Baseline to 6 months (End of study)	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)
Other	DSMP-SR Change from Baseline to 6 months (End of Study)	Diabetes Self-Management Profile	Assessment of Change: Baseline will be compared with 6 month measure (study end)
Other	PedsQL-Diabetes Module Change from Baseline to 6 months (study end)	Pediatric Quality of Life Scale	Assessment of Change: Baseline compared with 6 month measure (study end)
Primary	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	Mean blood glucose (MBG) Change From Baseline to 6 months (End of study)	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)