Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation

NCT04877730 | Completed Results DMC FDA Device

• 2 other identifiers: 210035UC4DK108483
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the meal anticipation module on a closed loop algorithm, assessing efficacy and safety.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes (T1D); Continuous Glucose Monitor (CGM); Insulin Pump; Fully Automated Closed Loop (FCL); Hybrid Closed Loop (HCL)

Outcome Measures

Primary Outcomes (1)

• Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours

  Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following breakfast. Higher TIR is a positive outcome.

  The 5 hour period following breakfast during the study admission

Secondary Outcomes (26)

• Time in Range (TIR) 70-180 mg/dL Overall

  The 24 hour study admission from 4pm to 4pm

• Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours

  The 5 hour period following dinner during the study admission

• Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours

  The 5 hour period following lunch during the study admission

• Time Below Range (TBR) From Breakfast Time + 5 Hours

  The 5 hour period following breakfast during the study admission

• Time Below Range (TBR) Overall

  The 24 hour study admission from 4pm to 4pm

Study Arms (3)

FCL (Fully Closed Loop)

EXPERIMENTAL

Closed-loop control without meal anticipation module without meal bolus

Device: Fully Closed Loop (FCL)

FCL+ (Fully Closed Loop with meal anticipation)

EXPERIMENTAL

Closed-loop control with meal anticipation module without meal bolus

Device: Fully Closed Loop with meal anticipation module (FCL+)

HCL (Hybrid Closed Loop)

EXPERIMENTAL

Closed-loop control without meal anticipation module with meal bolus

Device: Hybrid Closed Loop (HCL)

Interventions

Fully Closed Loop (FCL) DEVICE

Closed loop without a meal anticipation module without announced carbohydrate

FCL (Fully Closed Loop)

Fully Closed Loop with meal anticipation module (FCL+) DEVICE

Closed loop with a meal anticipation module and without announced carbohydrate

FCL+ (Fully Closed Loop with meal anticipation)

Hybrid Closed Loop (HCL) DEVICE

Closed loop without a meal anticipation module with announced carbohydrate

HCL (Hybrid Closed Loop)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18.0 and ≤70 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 University of Virginia (UVa) closed-loop system throughout study admission
• Willingness to use the insulin supplied by the study for the hotel stay, if not already using that preparation. Study insulin will be lispro (Humalog) or aspart (Novolog)
• 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 1g/kg of carbohydrate per day during the hotel admission
• Willingness to reschedule if placed on oral steroids
• An understanding and willingness to follow the protocol and signed informed consent

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
• Known contact with a COVID-19 positive individual within 14 days of the hotel/rental house studies.

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Garcia-Tirado J, Colmegna P, Villard O, Diaz JL, Esquivel-Zuniga R, Koravi CLK, Barnett CL, Oliveri MC, Fuller M, Brown SA, DeBoer MD, Breton MD. Assessment of Meal Anticipation for Improving Fully Automated Insulin Delivery in Adults With Type 1 Diabetes. Diabetes Care. 2023 Sep 1;46(9):1652-1658. doi: 10.2337/dc23-0119.

  PMID: 37478323 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: Sue Brown
• Organization: University of Virginia

sab2f@virginia.edu

434-982-0602

Study Officials

• Sue Brown, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 7, 2021
• Study Start: May 21, 2021
• Primary Completion: March 4, 2022
• Study Completion: March 6, 2022
• Last Updated: May 23, 2024
• Results First Posted: May 17, 2023

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Generally data will be made available after the primary publications of each study.
• Access Criteria: Data Sharing agreements will be formulated by the study team.

Locations

US (1)