Type 1 DiabetesNCT02688218
Exercise Detection Study
A study testing Aerobic Exercise and Resistance Exercise in people with Type 1 Diabetes, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The risk of hypoglycemia in individuals with type 1 diabetes increases considerably during exercise. As a result, many patients with type 1 diabetes experience fear of and reluctance to pursue physical activity, in order to avoid the discomforting symptoms associated with hypoglycemia. 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?
- Aerobic Exercise and Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 2 Feb 2018
- 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
- Male or female subjects 21 to 45 years of age with a diagnosis of T1D for at least 6 months on an insulin pump.
- Physically active on a regular basis, i.e. at least 3 days of scheduled physical activity per week and willing to perform approximately 60 minutes of exercise (as determined by the investigator after reviewing the subjects activity level).
- Willingness to follow all study procedures.
- Willingness to sign informed consent and HIPAA documents.
- Male or female subjects 21 to 45 years of age.
- Physically active on a regular basis, i.e. at least 3 days of scheduled physical activity per week and willing to perform approximately 60 minutes of exercise (as determined by the investigator after reviewing the subjects activity level).
- Willingness to follow all study procedures.
- Willingness to sign informed consent and HIPAA documents.
Who cannot join
- Pregnancy or Lactation: i. For women of childbearing potential, there is a requirement for a negative urine pregnancy test. b. 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. c. Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as report by the OHSU laboratory). d. Hematocrit of less than or equal to 34%. e. History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. f. Adrenal insufficiency. g. Any active infection. h. Known or suspected abuse of alcohol, narcotics, or illicit drugs (except marijuana use).
- Seizure disorder. j. Active foot ulceration. k. Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication. l. Major surgical operation within 30 days prior to screening. m. Use of an investigational drug within 30 days prior to screening. n. Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus). o. Bleeding disorder, treatment with warfarin, or platelet count below 50,000. p. Current administration of oral or parenteral corticosteroids. q. 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). r. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen. s. Beta blockers or non-dihydropyridine calcium channel blockers. t. A positive response to any of the questions from the Physical Activity Readiness Questionnaire, see Appendix A. u. Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort. v. Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with the protocol.
- HEALTHY SUBJECT CRITERIA
- Pregnancy or Lactation: For women of childbearing potential, there is a requirement for a negative urine pregnancy test.
- Any history or evidence of renal insufficiency, adrenal insufficiency, liver disease or anemia.
- A history of cerebrovascular disease or coronary artery disease (or angina) regardless of the time since occurrence.
Show all 19Show fewer
- Congestive heart failure, New York Heart Association (NYHA) any class.
- Diagnosis of 1st, 2nd or 3rd degree heart block or any arrhythmia judged by the investigator to be exclusionary.
- Any condition which, in the opinion of the investigator, makes it difficult to engage in vigorous physical activity.
- Any active infection.
- Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
- Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).
- Active malignancy, except basal cell or squamous cell skin cancers.
- Major surgical operation within 30 days prior to screening.
- Seizure disorder.
- Bleeding disorder, or treatment with warfarin.
- Use of any chronic medications.
- Use of an investigational drug within 30 days prior to screening.
- Any reason the principal investigator deems exclusionary.
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: Testing and Tuning a Multiparameter Exercise Detection Algorithm
The risk of hypoglycemia in individuals with type 1 diabetes increases considerably during exercise. As a result, many patients with type 1 diabetes experience fear of and reluctance to pursue physical activity, in order to avoid the discomforting symptoms associated with hypoglycemia. The bi-hormonal artificial pancreas, a device used for automatic delivery of insulin and glucagon subcutaneously to subjects with type 1 diabetes, is paving the way to revolutionize the management of this disease. The investigator's group has recently completed a study of the bi-hormonal artificial pancreas system during exercise, suggesting reduced hypoglycemia around the exercise period. In order to prepare for a future home study, the ability to detect, grade, and classify physical activity so as to appropriately adjust system parameters is vital in helping to prevent exercise induced hypoglycemia in the home setting.
This study is designed to collect 3-axis accelerometry data and heart rate data during a variety of different home activities, as well as during formal exercise in both healthy subjects and subjects with type 1 diabetes. Additionally, the investigators will observe the change in glucose levels before and after exercise in subjects with type 1 diabetes.
Read the detailed description
The artificial pancreas, a device used for automatic delivery of insulin and glucagon subcutaneously to subjects with type 1 diabetes, is paving the way to revolutionize the management of this disease. Already, the benefit of improved glycemic control compared to current open-loop pump therapy has been demonstrated in several trials. The investigator's group has shown that artificial pancreas algorithm dual hormone system effectively manages blood glucose in a clinic setting and the investigators have specifically shown great progress using glucagon to reduce hypoglycemic episodes outside of exercise. The investigators most recent inpatient study, as yet unpublished, shows that adjusting insulin and glucagon delivery during closed loop treatment, after announcing exercise, effectively reduces mean time below a glucose level of 70 mg/dl when compared to closed loop control without adjustments. The investigators utilized initial open-loop data from this study to help devise dosing changes for the artificial pancreas algorithm.
In order to prepare for a future home study, the ability to detect, grade, and classify physical activity so as to appropriately adjust system parameters is vital in helping to prevent exercise induced hypoglycemia in the home setting. Currently, our closed-loop system transmits heart rate and accelerometry outputs from a Zephyrlife BioPatch monitoring device to a Nexus 5 smart phone master controller via Bluetooth. The algorithm then converts the heart rate and accelerometry data into modified estimated energy expenditure - accounting for age, weight, height, sex, resting and sitting heart rates - to determine if exercise is present. However, further data collection is needed to hone the specificity and sensitivity of the detection algorithm to account for a wide variety of subject characteristics and activities.
This study is designed to collect 3-axis accelerometry data and heart rate data during a variety of different home activities, as well as during formal exercise, which included aerobic exercise (on a calibrated treadmill) and resistance exercise (straight-leg raises or equivalent) in healthy subjects as well as subjects with type 1 diabetes. Optionally VO2 data from a portable VO2 mask will be obtained. The data collected will be used to further enhance our algorithm that, in future closed-loop studies, will detect exercise and automatically trigger algorithmic adjustments to reduce exercise-related hypoglycemia during and after exercise in individuals with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Aerobic Exercise, Resistance Exercise
- Keywords
- exercise, artificial pancreas, hypoglycemia, type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Exercise for three 15 minute periods, with 10 minute rests between each period, and exercise intensity will vary between periods to achieve different energy expenditures, which may be determined based on VO2 measurements.
Resistance ExerciseBehavioural
Subjects will perform 5-15 minutes of up to 7 different activities of daily living, followed by 20 minutes of resistance exercise, such as straight leg raises.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic First, Resistance Second | Experimental | Subjects will complete three 15 minute periods of aerobic exercise, with 10 minute recovery between each period. This will be followed by 5-15 minute periods of up to 7 activities of daily living with an additional 20 minute period of resistance exercise, such as straight leg raises. Receives: Behavioral: Aerobic Exercise; Behavioral: Resistance Exercise |
| Resistance First, Aerobic Second | Experimental | Subjects will complete 5-15 minute periods of up to 7 activities of daily living with an additional 20 minute period of resistance exercise, such as straight leg raises. This will be followed by three 15 minute periods of aerobic exercise, with 10 minute recovery between each period. Receives: Behavioral: Aerobic Exercise; Behavioral: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Sensor Glucose in Subjects With Type 1 Diabetes
The mean change in sensor glucose before and after both exercise periods (aerobic and resistance) during the study visit, obtained from Dexcom G4 sensors in the subjects with type 1 diabetes.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
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 (4)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph El Youssef, Oregon Health and Science University
- Investigators
- Joseph El Youssef, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688218
- Sponsor's protocol ID
- 15452
- Status last verified
- Jun 2019
- First submitted
- 17 Feb 2016
- Last updated
- 29 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Castle JR, Engle JM, El Youssef J, Massoud RG, Yuen KC, Kagan R, Ward WK. Novel use of glucagon in a closed-loop system for prevention of hypoglycemia in type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1282-7. doi: 10.2337/dc09-2254. Epub 2010 Mar 23.
PubMed 20332355Jacobs PG, El Youssef J, Castle J, Bakhtiani P, Branigan D, Breen M, Bauer D, Preiser N, Leonard G, Stonex T, Ward WK. Automated control of an adaptive bihormonal, dual-sensor artificial pancreas and evaluation during inpatient studies. IEEE Trans Biomed Eng. 2014 Oct;61(10):2569-81. doi: 10.1109/TBME.2014.2323248. Epub 2014 May 13.
PubMed 24835122Jacobs PG, El Youssef J, Castle JR, Engle JM, Branigan DL, Johnson P, Massoud R, Kamath A, Ward WK. Development of a fully automated closed loop artificial pancreas control system with dual pump delivery of insulin and glucagon. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:397-400. doi: 10.1109/IEMBS.2011.6090127.
PubMed 22254332Jacobs PG, Resalat N, El Youssef J, Reddy R, Branigan D, Preiser N, Condon J, Castle J. Incorporating an Exercise Detection, Grading, and Hormone Dosing Algorithm Into the Artificial Pancreas Using Accelerometry and Heart Rate. J Diabetes Sci Technol. 2015 Oct 5;9(6):1175-84. doi: 10.1177/1932296815609371.
PubMed 26438720
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing and Tuning a Multiparameter Exercise Detection Algorithm
- ClinicalTrials.gov ID
- NCT02688218
- Acronym / sponsor ID
- 15452
- Conditions
- Type 1 Diabetes
- Keywords
- exercise, artificial pancreas, hypoglycemia, type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Posted 29 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The risk of hypoglycemia in individuals with type 1 diabetes increases considerably during exercise. As a result, many patients with type 1 diabetes experience fear of and reluctance to pursue physical activity, in order to avoid the discomforting symptoms associated with hypoglycemia. The bi-hormonal artificial pancreas, a device used for automatic delivery of insulin and glucagon subcutaneously to subjects with type 1 diabetes, is paving the way to revolutionize the management of this disease. The investigator's group has recently completed a study of the bi-hormonal artificial pancreas system during exercise, suggesting reduced hypoglycemia around the exercise period. In order to prepare for a future home study, the ability to detect, grade, and classify physical activity so as to appropriately adjust system parameters is vital in helping to prevent exercise induced hypoglycemia in the home setting.
This study is designed to collect 3-axis accelerometry data and heart rate data during a variety of different home activities, as well as during formal exercise in both healthy subjects and subjects with type 1 diabetes. Additionally, the investigators will observe the change in glucose levels before and after exercise in subjects with type 1 diabetes.
Detailed description
The artificial pancreas, a device used for automatic delivery of insulin and glucagon subcutaneously to subjects with type 1 diabetes, is paving the way to revolutionize the management of this disease. Already, the benefit of improved glycemic control compared to current open-loop pump therapy has been demonstrated in several trials. The investigator's group has shown that artificial pancreas algorithm dual hormone system effectively manages blood glucose in a clinic setting and the investigators have specifically shown great progress using glucagon to reduce hypoglycemic episodes outside of exercise. The investigators most recent inpatient study, as yet unpublished, shows that adjusting insulin and glucagon delivery during closed loop treatment, after announcing exercise, effectively reduces mean time below a glucose level of 70 mg/dl when compared to closed loop control without adjustments. The investigators utilized initial open-loop data from this study to help devise dosing changes for the artificial pancreas algorithm.
In order to prepare for a future home study, the ability to detect, grade, and classify physical activity so as to appropriately adjust system parameters is vital in helping to prevent exercise induced hypoglycemia in the home setting. Currently, our closed-loop system transmits heart rate and accelerometry outputs from a Zephyrlife BioPatch monitoring device to a Nexus 5 smart phone master controller via Bluetooth. The algorithm then converts the heart rate and accelerometry data into modified estimated energy expenditure - accounting for age, weight, height, sex, resting and sitting heart rates - to determine if exercise is present. However, further data collection is needed to hone the specificity and sensitivity of the detection algorithm to account for a wide variety of subject characteristics and activities.
This study is designed to collect 3-axis accelerometry data and heart rate data during a variety of different home activities, as well as during formal exercise, which included aerobic exercise (on a calibrated treadmill) and resistance exercise (straight-leg raises or equivalent) in healthy subjects as well as subjects with type 1 diabetes. Optionally VO2 data from a portable VO2 mask will be obtained. The data collected will be used to further enhance our algorithm that, in future closed-loop studies, will detect exercise and automatically trigger algorithmic adjustments to reduce exercise-related hypoglycemia during and after exercise in individuals with type 1 diabetes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic First, Resistance Second | Experimental | Behavioral: Aerobic Exercise, Behavioral: Resistance ExerciseSubjects will complete three 15 minute periods of aerobic exercise, with 10 minute recovery between each period. This will be followed by 5-15 minute periods of up to 7 activities of daily living with an additional 20 minute period of resistance exercise, such as straight leg raises. |
| Resistance First, Aerobic Second | Experimental | Behavioral: Aerobic Exercise, Behavioral: Resistance ExerciseSubjects will complete 5-15 minute periods of up to 7 activities of daily living with an additional 20 minute period of resistance exercise, such as straight leg raises. This will be followed by three 15 minute periods of aerobic exercise, with 10 minute recovery between each period. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female subjects 21 to 45 years of age with a diagnosis of T1D for at least 6 months on an insulin pump.
- Physically active on a regular basis, i.e. at least 3 days of scheduled physical activity per week and willing to perform approximately 60 minutes of exercise (as determined by the investigator after reviewing the subjects activity level).
- Willingness to follow all study procedures.
- Willingness to sign informed consent and HIPAA documents.
- Male or female subjects 21 to 45 years of age.
Key exclusion criteria (19 listed)
- Pregnancy or Lactation: i. For women of childbearing potential, there is a requirement for a negative urine pregnancy test. b. 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. c. Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as report by the OHSU laboratory). d. Hematocrit of less than or equal to 34%. e. History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. f. Adrenal insufficiency. g. Any active infection. h. Known or suspected abuse of alcohol, narcotics, or illicit drugs (except marijuana use).
- Seizure disorder. j. Active foot ulceration. k. Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication. l. Major surgical operation within 30 days prior to screening. m. Use of an investigational drug within 30 days prior to screening. n. Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus). o. Bleeding disorder, treatment with warfarin, or platelet count below 50,000. p. Current administration of oral or parenteral corticosteroids. q. 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). r. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen. s. Beta blockers or non-dihydropyridine calcium channel blockers. t. A positive response to any of the questions from the Physical Activity Readiness Questionnaire, see Appendix A. u. Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort. v. Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with the protocol.
- HEALTHY SUBJECT CRITERIA
- Pregnancy or Lactation: For women of childbearing potential, there is a requirement for a negative urine pregnancy test.
- Any history or evidence of renal insufficiency, adrenal insufficiency, liver disease or anemia.
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 |
|---|---|---|
| Aerobic ExerciseExercise for three 15 minute periods, with 10 minute rests between each period, and exercise intensity will vary between periods to achieve different energy expenditures, which may be determined based on VO2 measurements. | Behavioural | Aerobic First, Resistance Second, Resistance First, Aerobic Second |
| Resistance ExerciseSubjects will perform 5-15 minutes of up to 7 different activities of daily living, followed by 20 minutes of resistance exercise, such as straight leg raises. | Behavioural | Aerobic First, Resistance Second, Resistance First, Aerobic Second |
Primary outcome
Mean Change in Sensor Glucose in Subjects With Type 1 Diabetes
Time frame: 4 hours
The mean change in sensor glucose before and after both exercise periods (aerobic and resistance) during the study visit, obtained from Dexcom G4 sensors in the subjects with type 1 diabetes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20332355Castle JR, Engle JM, El Youssef J, Massoud RG, Yuen KC, Kagan R, Ward WK. Novel use of glucagon in a closed-loop system for prevention of hypoglycemia in type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1282-7. doi: 10.2337/dc09-2254. Epub 2010 Mar 23.
- Background: PubMed 24835122Jacobs PG, El Youssef J, Castle J, Bakhtiani P, Branigan D, Breen M, Bauer D, Preiser N, Leonard G, Stonex T, Ward WK. Automated control of an adaptive bihormonal, dual-sensor artificial pancreas and evaluation during inpatient studies. IEEE Trans Biomed Eng. 2014 Oct;61(10):2569-81. doi: 10.1109/TBME.2014.2323248. Epub 2014 May 13.
- Background: PubMed 22254332Jacobs PG, El Youssef J, Castle JR, Engle JM, Branigan DL, Johnson P, Massoud R, Kamath A, Ward WK. Development of a fully automated closed loop artificial pancreas control system with dual pump delivery of insulin and glucagon. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:397-400. doi: 10.1109/IEMBS.2011.6090127.
- Background: PubMed 26438720Jacobs PG, Resalat N, El Youssef J, Reddy R, Branigan D, Preiser N, Condon J, Castle J. Incorporating an Exercise Detection, Grading, and Hormone Dosing Algorithm Into the Artificial Pancreas Using Accelerometry and Heart Rate. J Diabetes Sci Technol. 2015 Oct 5;9(6):1175-84. doi: 10.1177/1932296815609371.
- Individual participant dataSharing planned: Undecided
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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.
Joseph El Youssef, 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 Aerobic Exercise and Resistance Exercise 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 8 inclusion and 19 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 29 Jul 2019. 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 29 Jul 2019). 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?
Mean Change in Sensor Glucose in Subjects With Type 1 Diabetes (time frame: 4 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 NCT02688218, which also lists 4 linked publications.
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 29 Jul 2019.