Hybrid Closed Loop in High Risk Youth With Type 1 Diabetes

NCT04807374 | Completed FDA Device

• 1 other identifier: Pro00013963
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The use of insulin pumps and continuous glucose monitors for Type 1 diabetes (T1D) has been shown to improve glycemic control while also decreasing the risk for acute and chronic complications. Unfortunately, there are vast disparities in access to this technology; non-Hispanic black youth with public healthcare insurance are the least likely to have access to these technologies. We propose to conduct a non-randomized interrupted time series study to assess the impact of hybrid closed loop (HCL) insulin delivery in underserved youths with poorly controlled T1D. Patients will complete standard diabetes education before beginning to use this technology and will be followed for 6-months after starting HCL to assess its impact on glycemic control and health-related quality of life.

Conditions

Type 1 Diabetes

Keywords

hybrid closed loop insulin delivery; healthcare disparities; diabetes technology

Outcome Measures

Primary Outcomes (1)

• Change in CGM Time in Range (TIR)

  To explore the effect of HCL insulin therapy with the Control IQ system on glycemic control as measured by time in range (TIR) in underserved youth with poorly controlled T1D.

  6 months

Secondary Outcomes (20)

• Changes in mean CGM glucose

  6 months

• Changes in glycemic management indicator (GMI)

  6 months

• Changes in coefficient of variation of mean glucose

  6 months

• Changes in CGM time in hypoglycemia (<70 mg/dL)

  6 months

• Changes in CGM time in hyperglycemia (>180 mg/dL)

  6 months

Study Arms (1)

Single arm- HCL Therapy

EXPERIMENTAL

Single arm study with all participants being treated with HCL for 6 months given the non-randomized interrupted time series study design.

Device: Control IQ

Interventions

Control IQ DEVICE

We aim to conduct a non-randomized prospective interrupted time series pilot study to investigate the effect of HCL insulin delivery on glycemic control in underserved adolescents with poorly controlled T1D.

Single arm- HCL Therapy

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients clinically diagnosed with T1D managed with insulin for at least 1 year
• Black race
• Public healthcare insurance
• Male or female ages ≥ 6 and \< 21 years
• Not currently using insulin pump therapy
• Poorly controlled T1D: one A1c value ≥ 10% in the preceding two years and a second A1c value ≥ 10% at enrollment
• Investigators and primary clinical endocrine clinician have confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
• Living with one or more parent/legal guardian/ friend (for adults only) knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
• Total daily insulin dose of at least 10 units per day based on FDA approval for Control IQ
• For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential at study entry and can be repeated as necessary in case of clinical concern. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• Not currently using and willingness not to start any non-insulin glucose-lowering agent during the course of the trial
• Fluent in English as the Control IQ technology is currently available only in English
• Willing to adhere to the study regimen

You may not qualify if:

• Concurrent use of any non-insulin diabetes medications
• More than 3 episodes of DKA in the year prior to enrollment
• Major illnesses other than T1D
• Significant cognitive limitations and major psychiatric disorders
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study
• Having immediate family members employed by Tandem Diabetes Care, Inc., TypeZero Technologies, LLC, Dexcom, Inc. or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Sponsors & Collaborators

• Children's National Research Institute: lead
• Tandem Diabetes Care, Inc.: collaborator
• DexCom, Inc.: collaborator

Study Sites (1)

Children's National

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• Marks BE, Grundman JB, Meighan S, Monaghan M, Streisand R, Perkins A. Hybrid Closed Loop Systems Improve Glycemic Control and Quality of Life in Historically Minoritized Youth with Diabetes. Diabetes Technol Ther. 2024 Mar;26(3):167-175. doi: 10.1089/dia.2023.0450.

  PMID: 38444316 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Amanda Perkins

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adv Pract Nurse Practitioner

Model Details: non-randomized interrupted time series

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 19, 2021
• Study Start: June 1, 2021
• Primary Completion: March 22, 2023
• Study Completion: June 22, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)