- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03859401
Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas
Hypoglycemia Prevention During and After Moderate Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas With Exercise Behavior Recognition
Study Overview
Status
Conditions
Detailed Description
Exercise remains a challenge to AP systems; more specifically, by the time exercise is detected it is often too late to avoid hypoglycemia without the ingestion of rapid carbohydrates or the use of rescue injections, such as glucagon. To this avail, the investigators propose to add a novel Model Predictive Control module to the proven USS system. This module is designed to compute insulin doses every 5 minutes that are designed to "optimally" maintain glycaemia around a target of 120mg/dL. The optimality is defined mathematically as minimizing deviations from basal rate injections and the distance between current and future (up to 2h) glycaemia from a physiologically feasible trajectory back down (or up) to a pre-specified target. Furthermore, the novel control system, labelled Multi Stage MPC or Ensemble MPC, accounts for a preset number of exercise scenarios during the prediction horizon, these scenarios being derived from the user historical record; this setup allows the control system to anticipate expected exercise bouts up to 2h in advance while maintaining the condition for optimal glycemic control.
By adding such module to a well validated system, the investigators expect an improvement in protection against hypoglycemia during and immediately after physical activity without increase in hyperglycemia. To demonstrate the feasibility of this approach, the novel anticipatory system will be compared to a naïve AP system during highly supervised hotel admissions with afternoon exercise. Participants will be asked to exercise regularly in the late afternoon during a month of data collection to generate the patterns to be anticipated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Inability to be physically active for at least 30 minutes per day for at least 4 times per week
- Current enrollment in another clinical trial, unless approved by the investigators of both studies or if clinical trial is a non-interventional registry trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control - Experimental Admissions
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.
|
This AP controller has the ability to anticipate exercise activity by use of trends seen during the Data Collection Period.
This AP controller does not have the ability to anticipate exercise activity.
|
Experimental: Experimental - Control Admissions
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.
|
This AP controller has the ability to anticipate exercise activity by use of trends seen during the Data Collection Period.
This AP controller does not have the ability to anticipate exercise activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of hypoglycemic occurrences in relation to exercise activity
Time Frame: 2 Hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent CGM below 50 mg/dL
Time Frame: 36 Hours
|
Percent CGM below 50 mg/dL
|
36 Hours
|
Percent CGM below 54 mg/dL
Time Frame: 36 Hours
|
Percent CGM below 54 mg/dL
|
36 Hours
|
Percent CGM below 60 mg/dL
Time Frame: 36 Hours
|
Percent CGM below 60 mg/dL
|
36 Hours
|
Percent CGM below 70 mg/dL
Time Frame: 36 Hours
|
Percent CGM below 70 mg/dL
|
36 Hours
|
Percent CGM between 70 and 180 mg/dL
Time Frame: 36 Hours
|
Percent CGM between 70 and 180 mg/dL
|
36 Hours
|
Percent CGM above 180 mg/dL
Time Frame: 36 Hours
|
Percent CGM above 180 mg/dL
|
36 Hours
|
Percent CGM above 250 mg/dL
Time Frame: 36 Hours
|
Percent CGM above 250 mg/dL
|
36 Hours
|
Percent CGM above 300 mg/dL
Time Frame: 36 Hours
|
Percent CGM above 300 mg/dL
|
36 Hours
|
Average CGM
Time Frame: 36 Hours
|
Average CGM
|
36 Hours
|
CGM Coefficient of Variation
Time Frame: 36 Hours
|
Coefficient of Variation of the CGM Values
|
36 Hours
|
CGM-based Low Blood Glucose Index
Time Frame: 36 Hours
|
CGM-based Low Blood Glucose Index
|
36 Hours
|
CGM-based High Blood Glucose Index
Time Frame: 36 Hours
|
CGM-based High Blood Glucose Index
|
36 Hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Amount of Insulin Used
Time Frame: 36 Hours
|
Total Amount of Insulin Used
|
36 Hours
|
Number of Hypoglycemic Episodes
Time Frame: 36 Hours
|
Number of Hypoglycemic Episodes as defined by contiguous CGM below 70 mg/dL
|
36 Hours
|
Number of Rescue Carbohydrates Administrations
Time Frame: 36 Hours
|
Number of Rescue Carbohydrates Administrations
|
36 Hours
|
Total Amount of Rescue Carbohydrates
Time Frame: 36 Hours
|
Total Amount of Rescue Carbohydrates
|
36 Hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marc Breton, PhD, University of Virginia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 180039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypoglycemia
-
University of UlmRecruitingHypoglycemia, ReactiveGermany
-
University of ArizonaNot yet recruiting
-
Milton S. Hershey Medical CenterDexCom, Inc.; Children's Miracle NetworkRecruiting
-
Zealand University HospitalUnknownHypoglycemia, ReactiveDenmark
-
MBX BiosciencesProSciento, Inc.RecruitingPostbariatric HypoglycemiaUnited States
-
University Hospital, Basel, SwitzerlandBoehringer IngelheimRecruitingPostprandial HypoglycemiaSwitzerland
-
University of NebraskaCompletedNeonatal HypoglycemiaUnited States
-
Vogenx, Inc.CompletedPostbariatric HypoglycemiaUnited States
-
Stanford UniversityCompletedNeonatal HypoglycemiaUnited States
-
Diva De LeonLester and Liesel Baker FoundationCompletedPostprandial HypoglycemiaUnited States
Clinical Trials on EnMPC (Ensemble Model Predictive Control) AP Controller
-
University of LouisvilleCompletedRenal Insufficiency, Chronic | Anemia of Chronic Kidney Disease | Anemia, Iron DeficiencyUnited States
-
Stanford UniversityWithdrawnType 1 Diabetes MellitusUnited States
-
B. Braun Melsungen AGCompleted
-
B. Braun Melsungen AGCompletedCritical IllnessAustria
-
Sansum Diabetes Research InstituteUniversity of California, Santa BarbaraCompletedType 1 Diabetes MellitusUnited States
-
University of VirginiaJuvenile Diabetes Research FoundationCompletedType 1 DiabetesUnited States
-
Yale UniversityHarvard UniversityCompletedType1 DiabetesUnited States
-
Medical University of GrazCompletedIntensive CareAustria
-
University of VirginiaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Centre d'Etudes et de Recherche pour l'Intensification...CompletedDiabetes Mellitus, Type 1 | Closed LoopFrance