Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes

NCT04545567 | Completed Results DMC FDA Device

• 1 other identifier: 200235
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The study team will be comparing two investigational Artificial Pancreas (AP) systems that the UVA Center for Diabetes Technology has developed. An artificial pancreas system delivers insulin automatically based on a blood glucose level that is provided from a continuous glucose monitor (CGM).

Conditions

Type 1 Diabetes

Keywords

Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Insulin Pump; Closed Loop Control

Outcome Measures

Primary Outcomes (1)

• Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal

  Percentage of time from dinner time until midnight with blood glucose in range 70-180 mg/dL in the unannounced meal

  6 hours

Secondary Outcomes (19)

• Number of Hypoglycemia Events From Dinner Time Until Midnight

  6 hours

• Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL

  6 hours

• Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL

  6 hours

• Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL

  6 hours

• Units of Insulin Injected From Dinner Time Until Midnight

  6 hours

Study Arms (2)

RocketAP

EXPERIMENTAL

Adolescents will be assessed for a 48-70 hour period on the Rocket AP. This time will include two dinner times, one with and one without announcement of carbohydrate content. This is a cross-over study, so all participants will also be tested on the USS Virginia system under the same conditions.

Device: RocketAP

USS Virginia

ACTIVE COMPARATOR

Adolescents will be assessed for a 48-70 hour period on the USS Virginia system. This time will include two dinner times, one with and one without announcement of carbohydrate content. This is a cross-over study, so all participants will also be tested on the Rocket AP system under the same conditions.

Device: USS Virginia

Interventions

RocketAP DEVICE

Artificial pancreas system which is designed to be able to identify when you have eaten and provide insulin for this meal

RocketAP

USS Virginia DEVICE

Artificial pancreas system which responds to glucose fluctuations by modulating insulin delivery but does not specifically detect meal ingestion

USS Virginia

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≥12.0 and ≤25 years old at time of consent
• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
• Currently using insulin for at least six months
• Currently using insulin pump for at least three months
• Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
• Access to internet and willingness to upload data during the study as needed
• For females, not currently known to be pregnant or breastfeeding
• 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 childbearing potential. 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.
• Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
• Willingness to use the UVa artificial pancreas system throughout study sessions.
• Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
• Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/d
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
• Willingness to eat at least 1 g/kg of carbohydrate per day during the camp/hotel admission
• Willingness to reschedule Study Dinner Sessions if placed on oral steroids

You may not qualify if:

• History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• Pregnancy or intent to become pregnant during the trial
• Currently being treated for a seizure disorder
• Planned surgery during study duration
• Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
• Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

• Garcia-Tirado J, Diaz JL, Esquivel-Zuniga R, Koravi CLK, Corbett JP, Dawson M, Wakeman C, Barnett CL, Oliveri MC, Myers H, Krauthause K, Breton MD, DeBoer MD. Advanced Closed-Loop Control System Improves Postprandial Glycemic Control Compared With a Hybrid Closed-Loop System Following Unannounced Meal. Diabetes Care. 2021 Aug 15:dc210932. doi: 10.2337/dc21-0932. Online ahead of print.

  PMID: 34400480 RESULT

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

Results Point of Contact

• Title: Mark DeBoer
• Organization: University of Virginia

mdd5z@virginia.edu

1 434 924 0123

Study Officials

• Mark D DeBoer, MD, MSc, MCR

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized cross-over trial assessing glycemic responses to two different approaches to insulin dosing for carbohydrate ingestion (announced vs. unannounced), with two different AP systems (RocketAP vs. USS Virginia, aka Control-IQ, in random order)

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 11, 2020
• Study Start: December 16, 2020
• Primary Completion: January 18, 2021
• Study Completion: January 21, 2021
• Last Updated: April 20, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Generally will be available after publications completed.
• Access Criteria: No restrictions for access.

Locations

US (1)