Diabetes Mellitus Type 1NCT02092220
A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas
A study testing Bionic Pancreas and Insulin pump with or without CGM in people with Diabetes Mellitus Type 1, run by Massachusetts General Hospital at 4 sites in United States.
Trial summary
This study will test the hypothesis that a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Bionic Pancreas and Insulin pump with or without CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2014to Dec 2016
- 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
- Diabetes 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 judgement of the site principal investigator).
- Employee or student working or studying during most of the week at one of the participating campuses (Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA)
- Lives within a 30 minute drive-time radius of the central monitoring location for one of the study sites
- Willing to remain within a 60 minute drive-time radius of the central monitoring location for one of the study sites during each of the 11-day study arms
- 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 two infusion sets and continuous glucose monitor (CGM) sensor and change sets frequently (at least one new glucagon infusion set daily)
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 human chorionic gonadotropin (HCG)] breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
- Need to go outside of the designated geographic boundaries during either arm of the study
- 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)
Show all 33Show fewer
- 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 besides type 1 diabetes
- 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 electrocardiogram (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 left anterior descending coronary artery (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 (CHF) [established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea]
- History of transient ischaemic attack (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 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 multiple endocrine neoplasia type 2A (MEN 2A), multiple endocrine neoplasia type 2B (MEN 2B), neurofibromatosis, or von Hippel-Lindau disease
- History of adrenal disease or tumor
- Hypertension with systolic blood pressure (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 radio-frequency (RF) interference
- Unable to completely avoid acetaminophen for duration of study
- 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 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 oral [e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter 2 (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 site principal investigator or overall principal investigator, would interfere with the safe completion of the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital (MGH) Diabetes Research Center
Boston, Massachusetts, 02114
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
Stanford University
Stanford, California, 94305
UMass Medical Center
Worcester, Massachusetts, 01655
About this study
This study will test the hypothesis that a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults with type 1 diabetes.
Please note that all participants must work or attend school at one of the following campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Bionic Pancreas, Insulin pump with or without CGM
- Keywords
- Bionic Pancreas, Insulin, Glucagon, Continuous Glucose Monitor
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bionic PancreasDevice
Insulin pump with or without CGMDevice
| Study group | Role | What they receive |
|---|---|---|
| Bionic Pancreas | Experimental | Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days. Receives: Device: Bionic Pancreas |
| Usual Care | Active comparator | Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days. Receives: Device: Insulin pump with or without CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11
Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.
Measured: Days 2 to 11 of each period
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11
Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 to 11 was calculated.
Measured: Days 2 to 11 of each period
Secondary outcomes (22)
Mean CGMG Values
Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged.
Measured: Day 1 and Days 1 to 11 in each period
Percentage of Time With CGMG Concentration by Ranges During Day 1
Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:
< 50 mg/dL (2.8 mmol/L) < 60 mg/dL (3.3 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)
Measured: Day 1 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:
< 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)
Measured: Days 1 to 11 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:
< 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)
Measured: Days 2 to 11 of each period
Percentage of Participants With Mean CGMG < 154 mg/dl
Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Glycosylated Hemoglobin A1C of 7%.
Measured: Day 1, Days 2 to11, Days 1 to11 of each period
Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.
Measured: Days 1-11
Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care
The percentage of days that participants reported the CGM device was being worn and working properly is reported.
Measured: Days 1-11 of each period
Glycated Albumin on Day 12
Measured: Day 12 of each period
1,5-anhydroglucitol on Day 12
Measured: Day 12 of each period
Anti-Insulin and Anti-Glucagon Antibodies on Day 12
Measured: Day 12 of each period
Number of Participants With Severe Hypoglycemic Events
A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.
Measured: 11 days of each period
Number of Episodes of Symptomatic Hypoglycemia
The number of episodes of symptomatic hypoglycemia were reported daily by the participant. The average number of episodes of symptomatic hypoglycemia per day was calculated.
Measured: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Number of Reported Carbohydrate Interventions for Hypoglycemia
The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported.
Measured: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Total Grams of Carbohydrate Taken for Hypoglycemia
The total grams of carbohydrate taken for hypoglycemia as reported daily by the participant were averaged.
The total number of grams of carbohydrate taken for hypoglycemia were reported daily by the participant. The total number of grams of carbohydrate taken are reported.
Measured: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Insulin Total Daily Dose
Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Measured: Day 1, Days 1 to 11, Days 2 to 11 of each period
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).
Measured: Day 1, Days 2 to 11, Days 1 to 11 of each period
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Measured: Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period
Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly
Not functioning properly includes issues due to system crash, communication problems between CGM and bionic pancreas, communication problems between bionic pancreas and pumps and pump malfunction.
Measured: 11 days
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores during Days 1 to 11 and Days 2 to 11 were calculated.
Measured: Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period
Change From Baseline in Body Weight
The change in body weight collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.
Measured: Baseline and Day 12 of each period
Change From Baseline in Hemoglobin
The change in the value of hemoglobin collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in hemoglobin and a positive change from Baseline indicates an increase in hemoglobin.
Measured: Baseline and Day 12 of each period
Number of Participants With Skin Rash
Measured: 11 days of each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionDec 2016
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 Diabetes Mellitus Type 1Studies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- 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
- NCT02092220
- Sponsor's protocol ID
- Multicenter Study
- Status last verified
- Oct 2017
- First submitted
- 18 Mar 2014
- Last updated
- 22 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
El-Khatib FH, Balliro C, Hillard MA, Magyar KL, Ekhlaspour L, Sinha M, Mondesir D, Esmaeili A, Hartigan C, Thompson MJ, Malkani S, Lock JP, Harlan DM, Clinton P, Frank E, Wilson DM, DeSalvo D, Norlander L, Ly T, Buckingham BA, Diner J, Dezube M, Young LA, Goley A, Kirkman MS, Buse JB, Zheng H, Selagamsetty RR, Damiano ER, Russell SJ. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet. 2017 Jan 28;389(10067):369-380. doi: 10.1016/S0140-6736(16)32567-3. Epub 2016 Dec 20.
PubMed 28007348
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas
- ClinicalTrials.gov ID
- NCT02092220
- Acronym / sponsor ID
- Multicenter Study
- Conditions
- Diabetes Mellitus Type 1
- Keywords
- Bionic Pancreas, Insulin, Glucagon, Continuous Glucose Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- Apr 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Posted 20 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the hypothesis that a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults with type 1 diabetes.
Please note that all participants must work or attend school at one of the following campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bionic Pancreas | Experimental | Device: Bionic PancreasBionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days. |
| Usual Care | Active comparator | Device: Insulin pump with or without CGMUsual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years and have had clinical type 1 diabetes for at least one year
- Diabetes 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 judgement of the site principal investigator).
- Employee or student working or studying during most of the week at one of the participating campuses (Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA)
- Lives within a 30 minute drive-time radius of the central monitoring location for one of the study sites
Key exclusion criteria (33 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 human chorionic gonadotropin (HCG)] breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
- Need to go outside of the designated geographic boundaries during either arm of the study
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 |
|---|---|---|
| Bionic Pancreas | Device | Bionic Pancreas |
| Insulin pump with or without CGM | Device | Usual Care |
Primary outcome
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11
Time frame: Days 2 to 11 of each period
Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11
Time frame: Days 2 to 11 of each period
Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 to 11 was calculated.
22 secondary outcomes
Mean CGMG Values
Time frame: Day 1 and Days 1 to 11 in each period
Percentage of Time With CGMG Concentration by Ranges During Day 1
Time frame: Day 1 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
Time frame: Days 1 to 11 of each period
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
Time frame: Days 2 to 11 of each period
Percentage of Participants With Mean CGMG < 154 mg/dl
Time frame: Day 1, Days 2 to11, Days 1 to11 of each period
Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
Time frame: Days 1-11
Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care
Time frame: Days 1-11 of each period
Glycated Albumin on Day 12
Time frame: Day 12 of each period
1,5-anhydroglucitol on Day 12
Time frame: Day 12 of each period
Anti-Insulin and Anti-Glucagon Antibodies on Day 12
Time frame: Day 12 of each period
Number of Participants With Severe Hypoglycemic Events
Time frame: 11 days of each period
Number of Episodes of Symptomatic Hypoglycemia
Time frame: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Number of Reported Carbohydrate Interventions for Hypoglycemia
Time frame: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Total Grams of Carbohydrate Taken for Hypoglycemia
Time frame: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Insulin Total Daily Dose
Time frame: Day 1, Days 1 to 11, Days 2 to 11 of each period
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Time frame: Day 1, Days 2 to 11, Days 1 to 11 of each period
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Time frame: Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period
Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly
Time frame: 11 days
Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Time frame: Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period
Change From Baseline in Body Weight
Time frame: Baseline and Day 12 of each period
Change From Baseline in Hemoglobin
Time frame: Baseline and Day 12 of each period
Number of Participants With Skin Rash
Time frame: 11 days of each period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28007348El-Khatib FH, Balliro C, Hillard MA, Magyar KL, Ekhlaspour L, Sinha M, Mondesir D, Esmaeili A, Hartigan C, Thompson MJ, Malkani S, Lock JP, Harlan DM, Clinton P, Frank E, Wilson DM, DeSalvo D, Norlander L, Ly T, Buckingham BA, Diner J, Dezube M, Young LA, Goley A, Kirkman MS, Buse JB, Zheng H, Selagamsetty RR, Damiano ER, Russell SJ. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet. 2017 Jan 28;389(10067):369-380. doi: 10.1016/S0140-6736(16)32567-3. Epub 2016 Dec 20.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bionic Pancreas and Insulin pump with or without CGM in people with Diabetes Mellitus Type 1, run by Massachusetts General Hospital at 4 sites 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 33 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 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 20 Oct 2017). 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 Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11 (time frame: Days 2 to 11 of each period). 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?
On the ClinicalTrials.gov record for NCT02092220, 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 22 Nov 2017.