Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas

NCT03859401 | Completed Results FDA Device

• 1 other identifier: 180039
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized crossover trial with 1:1 randomization to the admission sequence of using the Control AP system (rMPC - Naïve Model Predictive Control) vs. Experimental AP system (EnMPC - Ensemble Model Predictive Control) over approximately 4 months. Eligible participants will proceed to the Data Collection Phase for approximately 28 days, during which they will participate in regimented exercise activities. If the participant collected adequate data during the Data Collection Phase, they will be randomized and undergo the study admissions in the assigned sequence. Each admission is approximately 36 hours in length and will consist of one afternoon of exercise and one without.

Conditions

Type 1 Diabetes Mellitus; Hypoglycemia

Keywords

Artificial Pancreas; Continuous Glucose Monitor; Exercise; Exercise-Induced Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Number of Hypoglycemic Occurrences in Relation to Exercise Activity

  Number of hypoglycemic occurrences immediately before, during, and immediately after exercise (\~5-7pm) as defined by more than one consecutive CGM values below 70 mg/dL or hypoglycemic treatment per glycemic guidelines.

  2 Hours

Secondary Outcomes (10)

• Average CGM

  36 Hours

• Percent Time CGM Below 54 mg/dL

  36 Hours

• Percent Time CGM Below 70 mg/dL

  36 Hours

• Percent Time CGM Between 70 and 180 mg/dL

  36 Hours

• Percent Time CGM Between 70 and 140 mg/dL

  36 Hours

Other Outcomes (2)

• Total Amount of Insulin Used

  36 Hours

• Number of Hypoglycemic Episodes

  36 Hours

Study Arms (2)

Control - Experimental Admissions

EXPERIMENTAL

Subjects will be randomized following the Data Collection Phase in a 1:1 ratio. Subjects in the Control-Experimental Arm will undergo the Control Admission first, utilizing an artificial pancreas (AP) controller that does not anticipate exercise (rMPC - naïve model predictive control), followed by the Experimental Admission, which will utilize an AP controller that has the ability to anticipate exercise (EnMPC - ensemble model predictive control). During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening. Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.

Device: EnMPC (Ensemble Model Predictive Control) AP Controller; Device: rMPC (Naïve Model Predictive Control) AP Controller

Experimental - Control Admissions

EXPERIMENTAL

Subjects will be randomized following the Data Collection Phase in a 1:1 ratio. Subjects in the Experimental-Control Arm will undergo the Experimental Admission first, utilizing an artificial pancreas (AP) controller that has the ability to anticipate exercise (EnMPC), followed by the Control Admission, which will utilize an AP controller that does not have the ability to anticipate exercise (rMPC). During the 36-hour admissions, subjects will begin using the study AP system (control or experimental) on Day 1 around midday with a scheduled exercise activity in the evening. Day 2 will consist of minimal activity and subjects will be discharged in the evening on Day 2.

Device: EnMPC (Ensemble Model Predictive Control) AP Controller; Device: rMPC (Naïve Model Predictive Control) AP Controller

Interventions

EnMPC (Ensemble Model Predictive Control) AP Controller DEVICE

This AP controller has the ability to anticipate exercise activity by use of trends seen during the Data Collection Period.

Control - Experimental Admissions; Experimental - Control Admissions

rMPC (Naïve Model Predictive Control) AP Controller DEVICE

This AP controller does not have the ability to anticipate exercise activity.

Control - Experimental Admissions; Experimental - Control Admissions

Eligibility Criteria

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

You may qualify if:

• Age ≥18 and ≤65 years
• Clinical diagnosis of Type 1 Diabetes for at least one year
• Currently using an insulin pump for at least 6 months
• Uses insulin parameters such as carbohydrate ratio and correction factors consistently on their insulin pump in order to dose insulin for meals or corrections
• Access to internet and willingness to upload data during the study
• Willingness to be physically active for at least 30 minutes per day at least 4 times per week
• Willingness to perform the required exercise regimen during Data Collection Period
• Willingness to not perform regular exercise outside of the study-regimented exercise window
• For females, not currently pregnant or breastfeeding. If a female is of child-bearing potential and sexually active, she must agree to use a form of contraception to prevent pregnancy while participating in the study.
• An understanding and willingness to follow the protocol and sign 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
• Coronary artery disease or heart failure, unless written clearance is received from a cardiologist or primary care provider and documentation of a negative stress test within the year
• History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
• Clinically significant electrocardiogram (ECG) at time of Screening, as interpreted by the study medical physician.
• Use of non-insulin glucose-lowering agent (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) with the exception of participants who have been on a stable dose of Metformin for at least 3 months.
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
• Inpatient psychiatric treatment in the past 6 months
• Presence of a known adrenal disorder
• Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
• Uncontrolled thyroid disease
• Use of an automated insulin delivery mechanism that is not FDA approved during the data collection phase
• Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team

Sponsors & Collaborators

• Marc Breton: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Garcia-Tirado J, Brown SA, Laichuthai N, Colmegna P, Koravi CLK, Ozaslan B, Corbett JP, Barnett CL, Pajewski M, Oliveri MC, Myers H, Breton MD. Anticipation of Historical Exercise Patterns by a Novel Artificial Pancreas System Reduces Hypoglycemia During and After Moderate-Intensity Physical Activity in People with Type 1 Diabetes. Diabetes Technol Ther. 2021 Apr;23(4):277-285. doi: 10.1089/dia.2020.0516. Epub 2020 Dec 1.

  PMID: 33270531 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Motor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Marc Breton
• Organization: UVA Center for Diabetes Technology

mb6nt@virginia.edu

434-982-6484

Study Officials

• Marc Breton, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: April 12, 2019
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available after the publication of the manuscript.
• Access Criteria: The Data Sharing Agreements will be formulated by the study team

Locations

US (1)