Type 1 DiabetesNCT02241889
Three-way, Cross-over Closed-loop Exercise Study
A study testing Insulin pump therapy in people with Type 1 Diabetes, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Blood glucose control systems that utilize both insulin and glucagon to manage blood sugar are paving the way to revolutionize the management of this disease. The benefit of improved control of blood sugar levels compared to standard insulin pump therapy has already been demonstrated. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin pump therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2015
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 21 to 45 years of age.
- Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
- Current use of an insulin pump.
- Willingness to follow all study procedures, including attending all clinic visits.
- Willingness to sign informed consent and HIPAA documents.
Who cannot join
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as report by the OHSU laboratory).
- Impaired liver function, defined as AST or ALT ≥2.5 times upper limit of normal, according to OHSU laboratory reference ranges.
- Hematocrit of less than or equal to 34%.
- History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator.
Show all 27Show fewer
- Adrenal insufficiency.
- Any active infection.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs.
- Seizure disorder.
- Active foot ulceration.
- Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
- Major surgical operation within 30 days prior to screening.
- Use of an investigational drug within 30 days prior to screening.
- Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
- Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
- Allergy to aspart insulin.
- Allergy to glucagon.
- Insulin resistance requiring more than 200 units per day.
- Need for uninterrupted treatment of acetaminophen.
- Current administration of oral or parenteral corticosteroids.
- Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
- C peptide level of ≥0.5 ng/ml
- Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
- Beta blockers or non-dihydropyridine calcium channel blockers.
- A positive response to any of the questions from the Physical Activity Readiness Questionnaire.
- Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: A Randomized, Three-way, Cross-over Study to Assess the Efficacy of a Bi-hormonal Closed-loop System With vs Without Exercise Announcement vs Open-loop Therapy in Reducing Exercise-related Hypoglycemia
Blood glucose control systems that utilize both insulin and glucagon to manage blood sugar are paving the way to revolutionize the management of this disease. The benefit of improved control of blood sugar levels compared to standard insulin pump therapy has already been demonstrated. However, the risk of low blood sugar in type 1 diabetes increases considerably during exercise. The investigators research group has shown that small doses of glucagon can prevent low blood sugar when used in a blood sugar control system in patients with type 1 diabetes. However, as insulin sensitivity changes occur very rapidly during exercise, the ability to recognize the onset of physical activity in order to appropriately adjust the insulin and glucagon delivery is vital to helping prevent exercise-induced hypoglycemia.
The purpose of this study is to test how well a new modified blood sugar control system controls blood sugar during exercise compared to: 1) the current system without modifications and 2) standard insulin pump therapy.
Read the detailed description
Subjects will exercise during three study visits. During one visit, blood sugar will be controlled using standard insulin pump therapy. The investigators blood glucose control system will manage blood sugar for subjects during the other visits, with exercise announcement with insulin and glucagon delivery modifications during one visit. Treatment order will be randomized. Heart rate and accelerometry data will also be collected during each visit for the purposes of designing an exercise detection system for future studies.
Each subject will be asked to undergo an eligibility screening and to sign a consent form before any study procedures take place. At the screening appointment, after the consent form is signed, blood will be drawn for laboratory tests and a brief physical exam will be performed. An EKG and VO2max test will be completed at screening. Subjects that are enrolled in the study will come in for a sensor insertion visit up to 72 hours before each study visit. Subjects will undergo three 21-hour studies at an OHSU clinic or the OHSU clinical research center. Subjects will arrive at the research center at 8pm. Approximately 2 hours after a low-carbohydrate breakfast on Day 2, subjects will exercise for 45 minutes at 60% of their VO2max determined at screening. Three hours after completion of exercise, subjects will eat lunch. The study will end ~5 hours after lunch. Capillary blood glucose (CBG) will be measured every 2 hours during the day, every 3 hours at night and before and after exercise for studies using the blood glucose control system with subjects blinded to the CBG values. For studies using insulin pump therapy, the subject will sample CBG four times during the day as well as before and after exercise. Study staff will monitor studies remotely using a cloud server. An investigator or nurse practitioner with a specialty in endocrinology or internal medicine will be on site (located within the same complex) at all times.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin pump therapy, Closed-loop Artificial Pancreas Controller
- Keywords
- diabetes, closed-loop, bi-hormonal, exercise
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pump therapyDevice
Subject's own insulin pump will be used to manage blood glucose.
Closed-loop Artificial Pancreas ControllerDevice
Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
| Study group | Role | What they receive |
|---|---|---|
| Standard Insulin Pump Therapy | Active comparator | Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would. Receives: Device: Insulin pump therapy |
| Closed-loop without adjustment | Experimental | Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made. Receives: Device: Closed-loop Artificial Pancreas Controller |
| Closed-loop with adjustment | Experimental | Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made. Receives: Device: Closed-loop Artificial Pancreas Controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Time With Sensed Glucose < 70 mg/dl
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 70 mg/dl using Dexcom sensor downloads.
Measured: from start of exercise (~hour 12) until study completion (hour 21)
Percent of Time With Sensed Glucose Between 70-180 mg/dl
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values between 70-180 mg/dl using Dexcom sensor downloads.
Measured: from start of exercise (~hour 12) until study completion (hour 21)
Secondary outcomes (8)
Mean of the Mean Sensed Glucose Per Participant
Assess the mean sensed glucose per participant using Dexcom sensor downloads.
Measured: Entire 21 hour study duration excluding the first four hours
Number of Carbohydrate Treatments
Assess the number of rescue carbohydrate treatments.
Measured: Entire 21 hour study duration excluding the first four hours
Percent of Time With Sensed Glucose < 50 mg/dl
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 50 mg/dl using Dexcom sensor downloads.
Measured: Entire 21 hour study duration excluding the first four hours
Percent of Time With Sensed Glucose > 180 mg/dl
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values greater than 180 mg/dl using Dexcom sensor downloads.
Measured: Entire 21 hour study duration excluding the first four hours
Number of Events Capillary Blood Glucose (CBG) <70 mg/dl
Number of events measured with capillary blood glucose <70 mg/dl.
Measured: Entire 21 hour study duration excluding the first four hours
Number of Events With CBG Between 70 - 180 mg/dl
Assess the number of events that the Contour Next BG meter reported blood glucose values between 70-180 mg/dl using meter downloads.
Measured: Entire 21 hour study duration excluding the first four hours
Number of Events With CBG <50 mg/dl
Assess the total number of events that the Contour Next BG meter reported blood glucose values less than 50 mg/dl across all participants in each group.
Measured: Entire 21 hour study duration excluding the first four hours
Percent of Time of CBG>180 mg/dl
Assess the percent of time that the Contour Next BG meter reported blood glucose values greater than 180 mg/dl using meter downloads.
Measured: Entire 21 hour study duration excluding the first four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
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.
- Other trials for Type 1 DiabetesStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Castle, Oregon Health and Science University
- Investigators
- Jessica Castle, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241889
- Sponsor's protocol ID
- DP3-2014
- Status last verified
- Apr 2017
- First submitted
- 12 Sep 2014
- Last updated
- 22 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Three-way, Cross-over Study to Assess the Efficacy of a Bi-hormonal Closed-loop System With vs Without Exercise Announcement vs Open-loop Therapy in Reducing Exercise-related Hypoglycemia
- ClinicalTrials.gov ID
- NCT02241889
- Acronym / sponsor ID
- DP3-2014
- Conditions
- Type 1 Diabetes
- Keywords
- diabetes, closed-loop, bi-hormonal, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Posted 28 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blood glucose control systems that utilize both insulin and glucagon to manage blood sugar are paving the way to revolutionize the management of this disease. The benefit of improved control of blood sugar levels compared to standard insulin pump therapy has already been demonstrated. However, the risk of low blood sugar in type 1 diabetes increases considerably during exercise. The investigators research group has shown that small doses of glucagon can prevent low blood sugar when used in a blood sugar control system in patients with type 1 diabetes. However, as insulin sensitivity changes occur very rapidly during exercise, the ability to recognize the onset of physical activity in order to appropriately adjust the insulin and glucagon delivery is vital to helping prevent exercise-induced hypoglycemia.
The purpose of this study is to test how well a new modified blood sugar control system controls blood sugar during exercise compared to: 1) the current system without modifications and 2) standard insulin pump therapy.
Detailed description
Subjects will exercise during three study visits. During one visit, blood sugar will be controlled using standard insulin pump therapy. The investigators blood glucose control system will manage blood sugar for subjects during the other visits, with exercise announcement with insulin and glucagon delivery modifications during one visit. Treatment order will be randomized. Heart rate and accelerometry data will also be collected during each visit for the purposes of designing an exercise detection system for future studies.
Each subject will be asked to undergo an eligibility screening and to sign a consent form before any study procedures take place. At the screening appointment, after the consent form is signed, blood will be drawn for laboratory tests and a brief physical exam will be performed. An EKG and VO2max test will be completed at screening. Subjects that are enrolled in the study will come in for a sensor insertion visit up to 72 hours before each study visit. Subjects will undergo three 21-hour studies at an OHSU clinic or the OHSU clinical research center. Subjects will arrive at the research center at 8pm. Approximately 2 hours after a low-carbohydrate breakfast on Day 2, subjects will exercise for 45 minutes at 60% of their VO2max determined at screening. Three hours after completion of exercise, subjects will eat lunch. The study will end ~5 hours after lunch. Capillary blood glucose (CBG) will be measured every 2 hours during the day, every 3 hours at night and before and after exercise for studies using the blood glucose control system with subjects blinded to the CBG values. For studies using insulin pump therapy, the subject will sample CBG four times during the day as well as before and after exercise. Study staff will monitor studies remotely using a cloud server. An investigator or nurse practitioner with a specialty in endocrinology or internal medicine will be on site (located within the same complex) at all times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Insulin Pump Therapy | Active comparator | Device: Insulin pump therapySubjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would. |
| Closed-loop without adjustment | Experimental | Device: Closed-loop Artificial Pancreas ControllerSubjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made. |
| Closed-loop with adjustment | Experimental | Device: Closed-loop Artificial Pancreas ControllerSubjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 21 to 45 years of age.
- Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
- Current use of an insulin pump.
- Willingness to follow all study procedures, including attending all clinic visits.
Key exclusion criteria (27 listed)
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as report by the OHSU laboratory).
- Impaired liver function, defined as AST or ALT ≥2.5 times upper limit of normal, according to OHSU laboratory reference ranges.
- Hematocrit of less than or equal to 34%.
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 |
|---|---|---|
| Insulin pump therapySubject's own insulin pump will be used to manage blood glucose. | Device | Standard Insulin Pump Therapy |
| Closed-loop Artificial Pancreas ControllerClosed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon. | Device | Closed-loop with adjustment, Closed-loop without adjustment |
Primary outcome
Percent of Time With Sensed Glucose < 70 mg/dl
Time frame: from start of exercise (~hour 12) until study completion (hour 21)
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 70 mg/dl using Dexcom sensor downloads.
Percent of Time With Sensed Glucose Between 70-180 mg/dl
Time frame: from start of exercise (~hour 12) until study completion (hour 21)
Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values between 70-180 mg/dl using Dexcom sensor downloads.
8 secondary outcomes
Mean of the Mean Sensed Glucose Per Participant
Time frame: Entire 21 hour study duration excluding the first four hours
Number of Carbohydrate Treatments
Time frame: Entire 21 hour study duration excluding the first four hours
Percent of Time With Sensed Glucose < 50 mg/dl
Time frame: Entire 21 hour study duration excluding the first four hours
Percent of Time With Sensed Glucose > 180 mg/dl
Time frame: Entire 21 hour study duration excluding the first four hours
Number of Events Capillary Blood Glucose (CBG) <70 mg/dl
Time frame: Entire 21 hour study duration excluding the first four hours
Number of Events With CBG Between 70 - 180 mg/dl
Time frame: Entire 21 hour study duration excluding the first four hours
Number of Events With CBG <50 mg/dl
Time frame: Entire 21 hour study duration excluding the first four hours
Percent of Time of CBG>180 mg/dl
Time frame: Entire 21 hour study duration excluding the first four hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Type 1 Diabetes
Active, not recruitingObservational study
Epidemiology of Diabetes Interventions and Complications (EDIC)
Type 1 Diabetes Mellitus
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
RecruitingPhase 2
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Recruiting
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion
Type 2 Diabetes, Healhty
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.
Jessica Castle, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin pump therapy in people with Type 1 Diabetes, run by Oregon Health and Science University 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 6 inclusion and 27 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 22 May 2017. 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 28 Oct 2015). 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?
Percent of Time With Sensed Glucose < 70 mg/dl (time frame: from start of exercise (~hour 12) until study completion (hour 21)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2017; AzTrials last refreshed its copy on 28 Oct 2026.