Type1diabetesNCT02969863
The Monitoring Study
A study testing Bihormonal Bionic Pancreas, Insulin Only Bionic Pancreas and Monitored for Hypoglycemia in people with Type1diabetes, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
To conduct an outpatient study testing two configurations of the bionic pancreas (bi-hormonal and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years of age) subjects with type 1 diabetes in a random-order crossover study versus usual care with an insulin pump with and without… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Bihormonal Bionic Pancreas, Insulin Only Bionic Pancreas and Monitored for Hypoglycemia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 28 Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and have had clinical type 1 diabetes for at least one year managed using an insulin pump for ≥ 6 months
- Prescription medication regimen stable for > 1 month (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgment of the principal investigator)
- Live within a 60 minute drive-time radius of the central monitoring location
- Willing to remain within a 120 minute drive-time radius of the central monitoring location throughout the study
- Have someone over 18 years of age who lives with them, has access to where they sleep, is willing to be in the house when the subject is sleeping, and is willing to receive calls from the study staff and check the welfare of the study subject if telemetry shows a technical problem or severe biochemical hypoglycemia without subject response and the subject does not answer their telephone (up to two individuals can share this role, but they must be willing to carefully coordinate with each other and the subject so that one of them is clearly designated as having this responsibility at any given time)
- Willing to wear one or two infusion sets and one Dexcom CGM sensor and change sets frequently (at least one new glucagon infusion set daily during bi-hormonal arms, and insulin infusion set every other day throughout the study)
- Willing to wear two additional CGM sensors that must be placed in the upper arm
Who cannot join
- Unable to provide informed consent (e.g. impaired cognition or judgment)
- Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory, unable to speak and read English)
- Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception Subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.
- Acceptable contraception methods include: Oral contraceptive pill (OCP), Intrauterine Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as Implanon, Nexplanon), Vaginal ring (such as NuvaRing), Progestin shot (such as Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis
- Need to go outside of the designated geographic boundaries during the study
Show all 44Show fewer
- Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
- Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more than 4 drinks in a day or use of marijuana during the trial
- Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of beta blockers will be allowed as long as the dose is stable and the subject does not meet the criteria for hypoglycemia unawareness while taking that stable dose, but use of benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)
- History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion.
- Renal failure on dialysis
- Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease
- Any known history of coronary artery disease including, but not limited to, history of myocardial infarction, stress test showing ischemia, history of angina, or history of intervention such as coronary artery bypass grafting, percutaneous coronary intervention, or enzymatic lysis of a presumed coronary occlusion)
- Abnormal EKG consistent with coronary artery disease or increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), prolonged QT interval (> 440 ms). Non-specific ST segment and T wave changes are not grounds for exclusion in the absence of symptoms or history of heart disease. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.
- Congestive heart failure (established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea)
- History of TIA or stroke
- Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants
- History of hypoglycemic seizures (grand-mal) or coma in the last year
- History of pheochromocytoma: fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor:
- Episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension
- Paroxysms of tachycardia, pallor, or headache
- Personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease
- History of adrenal disease or tumor
- Hypertension with systolic BP ≥160 mm Hg or diastolic BP ≥100 despite treatment
- Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with anti-psychotic medications that are known to affect glucose regulation.
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
- The presence of any other active implanted device
- Unable to completely avoid acetaminophen for duration of study
- Unable to completely avoid ascorbic acid (Vitamin C) for duration of study
- Unable to completely avoid salicylic acid (used in some pain relievers such as Aspirin and some skin care products)
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting
- Established history of allergy or severe reaction to adhesive or tape that must be used in the study
- History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight
- History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
- Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, DPP-4 inhibitors, SGLT-2 inhibitors) anti-diabetic medications
- Lives in or frequents areas with poor Verizon wireless network coverage (which would prevent remote monitoring)
- Any factors that, in the opinion of the principal investigator would interfere with the safe completion of the study
- A condition preventing or complicating the placement, operation or removal of the Senseonics sensor or wearing of transmitter, including upper extremity deformities or skin condition
- Currently receiving (or likely to need during the study period): immunosuppressant therapy, chemotherapy, anticoagulant/antithrombotic therapy (excluding aspirin), glucocorticoids (excluding ophthalmic or nasal). This does include the use of inhaled and topical glucocorticoids and antibiotics for chronic infection
- A condition requiring or likely requiring magnetic resonance imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy)
- A known topical or local anesthetic allergy
- A known glucocorticoids allergy
- The presence of any other CGM sensor or transmitter located in the upper arm (other location is acceptable)
- Hemoglobin < 12 g/dl
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Diabetes Research Center
Boston, Massachusetts, 02114
About this study
Official title: The Monitoring Study: Evaluating the Effect of Remote Monitoring For Hypoglycemia on Bionic Pancreas Safety and Efficacy
To conduct an outpatient study testing two configurations of the bionic pancreas (bi-hormonal and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years of age) subjects with type 1 diabetes in a random-order crossover study versus usual care with an insulin pump with and without remote monitoring of hypoglycemia.
Read the detailed description
The rationale for this study is to measure the safety of eliminating the glycemic monitoring that the investigators have done in all of the previous outpatient studies under both insulin only and bihormonal bionic pancreas control. The investigators are planning to transition the outpatient studies to an integrated bionic pancreas, the iLet, in the near future. The intended use of this device does not include remote monitoring, which would not be feasible on a commercial scale. Therefore, in this trial the investigators will test the effects on hypoglycemia of eliminating blood glucose related monitoring. In addition, the investigators will perform a pilot trial testing the effects of the bionic pancreas on food intake, exercise, weight and body composition. The primary purpose of this pilot is to assess the feasibility of performing these measurements in the context of a larger trial and to collect data that can be used to power sub-studies of pivotal trials looking at these outcomes. Finally, the investigators will test the accuracy of two new CGM devices to see if they have sufficient accuracy to provide glucose data to the bionic pancreas. If so, this would provide new options for users who may have difficulties with the only currently validated CGM for this purpose, the Dexcom G4 AP / G5 platform.
- Conditions
- Type1diabetes
- Being tested
- Bihormonal Bionic Pancreas, Insulin Only Bionic Pancreas, Monitored for Hypoglycemia, Not Monitored for Hypoglycemia
- Keywords
- bionic pancreas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bihormonal Bionic PancreasDevice
Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.
Insulin Only Bionic PancreasDevice
Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.
Monitored for HypoglycemiaOther
During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.
Not Monitored for HypoglycemiaOther
During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Arm - Monitored | Active comparator | Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored for CGM connectivity and hypoglycemia.
Monitored for hypoglycemia Receives: Other: Monitored for Hypoglycemia |
| Usual Care Arm - Unmonitored | Active comparator | Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored only for CGM connectivity, not hypoglycemia.
Not monitored for hypoglycemia Receives: Other: Not Monitored for Hypoglycemia |
| Bihormonal Bionic Pancreas - Monitored | Experimental | Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.
Monitored for hypoglycemia Receives: Device: Bihormonal Bionic Pancreas; Other: Monitored for Hypoglycemia |
| Bihormonal Bionic Pancreas - Unmonitored | Experimental | Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.
Not monitored for hypoglycemia Receives: Device: Bihormonal Bionic Pancreas; Other: Not Monitored for Hypoglycemia |
| Insulin Only Bionic Pancreas - Monitored | Experimental | Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia.
Monitored for hypoglycemia Receives: Device: Insulin Only Bionic Pancreas; Other: Monitored for Hypoglycemia |
| Insulin Only Bionic Pancreas - Unmonitored | Experimental | Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia.
Not monitored for hypoglycemia Receives: Device: Insulin Only Bionic Pancreas; Other: Not Monitored for Hypoglycemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time Spent With Dexcom CGMG < 60 mg/dl
A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl
Measured: days 2-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start1 Apr 2017
- Primary completion1 Jun 2017
- Study completion28 Dec 2017
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 Type1diabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven J. Russell, MD, PhD, Massachusetts General Hospital
- Investigators
- Steven J Russell, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969863
- Sponsor's protocol ID
- 2016P002450
- Status last verified
- Jul 2018
- First submitted
- 18 Nov 2016
- Last updated
- 30 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Monitoring Study: Evaluating the Effect of Remote Monitoring For Hypoglycemia on Bionic Pancreas Safety and Efficacy
- ClinicalTrials.gov ID
- NCT02969863
- Acronym / sponsor ID
- 2016P002450
- Conditions
- Type1diabetes
- Keywords
- bionic pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Posted 30 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To conduct an outpatient study testing two configurations of the bionic pancreas (bi-hormonal and insulin-only) with and without remote monitoring of hypoglycemia in 25 adult (≥ 18 years of age) subjects with type 1 diabetes in a random-order crossover study versus usual care with an insulin pump with and without remote monitoring of hypoglycemia.
Detailed description
The rationale for this study is to measure the safety of eliminating the glycemic monitoring that the investigators have done in all of the previous outpatient studies under both insulin only and bihormonal bionic pancreas control. The investigators are planning to transition the outpatient studies to an integrated bionic pancreas, the iLet, in the near future. The intended use of this device does not include remote monitoring, which would not be feasible on a commercial scale. Therefore, in this trial the investigators will test the effects on hypoglycemia of eliminating blood glucose related monitoring. In addition, the investigators will perform a pilot trial testing the effects of the bionic pancreas on food intake, exercise, weight and body composition. The primary purpose of this pilot is to assess the feasibility of performing these measurements in the context of a larger trial and to collect data that can be used to power sub-studies of pivotal trials looking at these outcomes. Finally, the investigators will test the accuracy of two new CGM devices to see if they have sufficient accuracy to provide glucose data to the bionic pancreas. If so, this would provide new options for users who may have difficulties with the only currently validated CGM for this purpose, the Dexcom G4 AP / G5 platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Usual Care Arm - Monitored | Active comparator | Other: Monitored for HypoglycemiaSubjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored for CGM connectivity and hypoglycemia. Monitored for hypoglycemia |
| Usual Care Arm - Unmonitored | Active comparator | Other: Not Monitored for HypoglycemiaSubjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored only for CGM connectivity, not hypoglycemia. Not monitored for hypoglycemia |
| Bihormonal Bionic Pancreas - Monitored | Experimental | Device: Bihormonal Bionic Pancreas, Other: Monitored for HypoglycemiaSubjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia. Monitored for hypoglycemia |
| Bihormonal Bionic Pancreas - Unmonitored | Experimental | Device: Bihormonal Bionic Pancreas, Other: Not Monitored for HypoglycemiaSubjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia. Not monitored for hypoglycemia |
| Insulin Only Bionic Pancreas - Monitored | Experimental | Device: Insulin Only Bionic Pancreas, Other: Monitored for HypoglycemiaSubjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia. Monitored for hypoglycemia |
| Insulin Only Bionic Pancreas - Unmonitored | Experimental | Device: Insulin Only Bionic Pancreas, Other: Not Monitored for HypoglycemiaSubjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia. Not monitored for hypoglycemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years and have had clinical type 1 diabetes for at least one year managed using an insulin pump for ≥ 6 months
- Prescription medication regimen stable for > 1 month (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgment of the principal investigator)
- Live within a 60 minute drive-time radius of the central monitoring location
- Willing to remain within a 120 minute drive-time radius of the central monitoring location throughout the study
- Have someone over 18 years of age who lives with them, has access to where they sleep, is willing to be in the house when the subject is sleeping, and is willing to receive calls from the study staff and check the welfare of the study subject if telemetry shows a technical problem or severe biochemical hypoglycemia without subject response and the subject does not answer their telephone (up to two individuals can share this role, but they must be willing to carefully coordinate with each other and the subject so that one of them is clearly designated as having this responsibility at any given time)
Key exclusion criteria (44 listed)
- Unable to provide informed consent (e.g. impaired cognition or judgment)
- Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory, unable to speak and read English)
- Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception Subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.
- Acceptable contraception methods include: Oral contraceptive pill (OCP), Intrauterine Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as Implanon, Nexplanon), Vaginal ring (such as NuvaRing), Progestin shot (such as Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis
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 |
|---|---|---|
| Bihormonal Bionic PancreasParticipants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings. | Device | Bihormonal Bionic Pancreas - Monitored, Bihormonal Bionic Pancreas - Unmonitored |
| Insulin Only Bionic PancreasParticipants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings. | Device | Insulin Only Bionic Pancreas - Monitored, Insulin Only Bionic Pancreas - Unmonitored |
| Monitored for HypoglycemiaDuring half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues. | Other | Bihormonal Bionic Pancreas - Monitored, Insulin Only Bionic Pancreas - Monitored, Usual Care Arm - Monitored |
| Not Monitored for HypoglycemiaDuring half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia. | Other | Bihormonal Bionic Pancreas - Unmonitored, Insulin Only Bionic Pancreas - Unmonitored, Usual Care Arm - Unmonitored |
Primary outcome
Percentage of Time Spent With Dexcom CGMG < 60 mg/dl
Time frame: days 2-7
A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Steven J Russell, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bihormonal Bionic Pancreas, Insulin Only Bionic Pancreas and Monitored for Hypoglycemia in people with Type1diabetes, run by Massachusetts General Hospital 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 7 inclusion and 44 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 30 Jul 2018. 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 30 Jul 2018). 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?
Percentage of Time Spent With Dexcom CGMG < 60 mg/dl (time frame: days 2-7). 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 30 Jul 2018.