Type 1 Diabetes MellitusNCT03859401
Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas
A study of Type 1 Diabetes Mellitus and Hypoglycemia, run by Marc Breton at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Hypoglycemia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2019to 13 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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)
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Hypoglycemia Prevention During and After Moderate Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas With Exercise Behavior Recognition
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus, Hypoglycemia
- Being tested
- EnMPC (Ensemble Model Predictive Control) AP Controller, rMPC (Naïve Model Predictive Control) AP Controller
- Keywords
- Artificial Pancreas, Continuous Glucose Monitor, Exercise, Exercise-Induced Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnMPC (Ensemble Model Predictive Control) AP ControllerDevice
This AP controller has the ability to anticipate exercise activity by use of trends seen during the Data Collection Period.
rMPC (Naïve Model Predictive Control) AP ControllerDevice
This AP controller does not have the ability to anticipate exercise activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: EnMPC (Ensemble Model Predictive Control) AP Controller; Device: rMPC (Naïve Model Predictive Control) AP Controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Hours
Secondary outcomes (10)
Average CGM
Average CGM value
Measured: 36 Hours
Percent Time CGM Below 54 mg/dL
Percentage of time CGM was below 54 mg/dL
Measured: 36 Hours
Percent Time CGM Below 70 mg/dL
Percentage of time CGM was below 70 mg/dL
Measured: 36 Hours
Percent Time CGM Between 70 and 180 mg/dL
Percentage of time CGM was between 70 and 180 mg/dL
Measured: 36 Hours
Percent Time CGM Between 70 and 140 mg/dL
Percentage of time CGM was between 70 and 140 mg/dL
Measured: 36 Hours
Percent Time CGM Above 180 mg/dL
Percentage of time CGM was above 180 mg/dL
Measured: 36 Hours
Percent Time CGM Above 250 mg/dL
Percentage of time CGM was above 250 mg/dL
Measured: 36 Hours
CGM Coefficient of Variation
Coefficient of Variation of the CGM Values
Measured: 36 Hours
CGM-based Low Blood Glucose Index
CGM-based Low Blood Glucose Index (LBGI) which is a metric used to quantify the risk of hypoglycemia (low blood sugar) based on self-monitored blood glucose (SMBG) data. LBGI is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values <1 suggest low risk of hypoglycemia.
Measured: 36 Hours
CGM Standard Deviation
Standard Deviation of the CGM Values
Measured: 36 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start12 Apr 2019
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Breton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Breton, University of Virginia
- Investigators
- Marc Breton, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859401
- Sponsor's protocol ID
- 180039
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2019
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Publications
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.
PubMed 33270531
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia Prevention During and After Moderate Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas With Exercise Behavior Recognition
- ClinicalTrials.gov ID
- NCT03859401
- Acronym / sponsor ID
- 180039
- Conditions
- Type 1 Diabetes Mellitus, Hypoglycemia
- Keywords
- Artificial Pancreas, Continuous Glucose Monitor, Exercise, Exercise-Induced Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Marc BretonUniversity, hospital or other
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - Experimental Admissions | Experimental | Device: EnMPC (Ensemble Model Predictive Control) AP Controller, Device: rMPC (Naïve Model Predictive Control) AP ControllerSubjects 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. |
| Experimental - Control Admissions | Experimental | Device: EnMPC (Ensemble Model Predictive Control) AP Controller, Device: rMPC (Naïve Model Predictive Control) AP ControllerSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnMPC (Ensemble Model Predictive Control) AP ControllerThis AP controller has the ability to anticipate exercise activity by use of trends seen during the Data Collection Period. | Device | Control - Experimental Admissions, Experimental - Control Admissions |
| rMPC (Naïve Model Predictive Control) AP ControllerThis AP controller does not have the ability to anticipate exercise activity. | Device | Control - Experimental Admissions, Experimental - Control Admissions |
Primary outcome
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.
10 secondary outcomes
Average CGM
Time frame: 36 Hours
Percent Time CGM Below 54 mg/dL
Time frame: 36 Hours
Percent Time CGM Below 70 mg/dL
Time frame: 36 Hours
Percent Time CGM Between 70 and 180 mg/dL
Time frame: 36 Hours
Percent Time CGM Between 70 and 140 mg/dL
Time frame: 36 Hours
Percent Time CGM Above 180 mg/dL
Time frame: 36 Hours
Percent Time CGM Above 250 mg/dL
Time frame: 36 Hours
CGM Coefficient of Variation
Time frame: 36 Hours
CGM-based Low Blood Glucose Index
Time frame: 36 Hours
CGM Standard Deviation
Time frame: 36 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33270531Garcia-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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Breton, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes Mellitus and Hypoglycemia, run by Marc Breton at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Hypoglycemic Occurrences in Relation to Exercise Activity (time frame: 2 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03859401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.