Diabetes Mellitus Type 1NCT02701257
The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas
A study testing iPhone bionic pancreas, iLet bionic pancreas and Xeris Xerisol glucagon in people with Diabetes Mellitus Type 1, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will compare two different models of a wearable bionic pancreas device (the iPhone-based bionic pancreas vs. the iLet bionic pancreas) in adult participant 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?
- iPhone bionic pancreas, iLet bionic pancreas and Xeris Xerisol glucagon
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- iPhone and iLet BP experiments
- 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 judgment of the principal investigator)
- iLet Infusion Set Sub-Study
- Age ≥ 18 years and have had clinical type 1 diabetes for at least one year
- Diabetes managed using an insulin pump for ≥ 6 months
Who cannot join
- iPhone and iLet BP experiments
- 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
- 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 32Show fewer
- Unwilling or unable to refrain on the study days from:acetaminophen in any form, use of marijuana, 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)
- 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
- 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
- Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, DPP-4 inhibitors, SGLT-2 inhibitors) anti-diabetic medications
- Hemoglobin < 12 g/dl
- Any factors that, in the opinion of the principal investigator would interfere with the safe completion of the study
- iLet Infusion Set Sub-Study
- 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 their insulin pump, impaired memory, unable to speak and read English)
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
- Hemoglobin < 11 g/dl
- Unable to establish IV access, or subject reports difficult IV access in the past
- History of allergy or severe reaction to adhesive or tape that must be used in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Diabetes Research Center
Boston, Massachusetts, 02114
About this study
This study will compare two different models of a wearable bionic pancreas device (the iPhone-based bionic pancreas vs. the iLet bionic pancreas) in adult participant with type 1 diabetes. Both bionic pancreas devices measure glucose levels every five minutes and then give insulin and/or glucagon automatically to regulate the blood glucose (BG).
Read the detailed description
The iPhone bionic pancreas has been used in earlier studies, during which volunteers used the system for up to 11 days at a time while living their normal lives at home and work. The iLet bionic pancreas has never been tested in humans. In this new study, volunteers will participate in a training visit to learn how both devices work. They will then use the iPhone-based BP for 1 day and the iLet BP for 1 day in random order using Lilly glucagon. They will then use the iLet BP for one additional day using Xeris Xerisol glucagon (a stable formulation of human glucagon).
A custom infusion set is required for this bihormonal system, to prevent future consumers from being able to accidentally swap their insulin and glucagon reservoirs and infusion sets, which could be potentially fatal. Previous experiments have demonstrated flaws in the infusion set design, requiring human experiments to be suspended and modifications to the infusion set be made. We believe the current infusion set has addressed these flaws by incorporating an anti-coring heel and a tri-beveled needle, and the infusion set sub-study is designed to isolate and study the infusion set function before further experiments using the iLet BP are conducted.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- iPhone bionic pancreas, iLet bionic pancreas, Xeris Xerisol glucagon, Lilly glucagon, iLet infusion set
- 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.
iPhone bionic pancreasDevice
An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
iLet bionic pancreasDevice
An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Xeris Xerisol glucagonDrug
Also called Xeris glucagon
A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
Lilly glucagonDrug
Also called glucagon
An aqueous formulation of human glucagon with limited stability that must be changed daily
iLet infusion setDevice
The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
Contact Detach infusion setDevice
The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
| Study group | Role | What they receive |
|---|---|---|
| iPhone bionic pancreas - Lilly glucagon | Active comparator | iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. Receives: Device: iPhone bionic pancreas; Drug: Lilly glucagon |
| iLet bionic pancreas - Lilly glucagon | Experimental | iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. Receives: Device: iLet bionic pancreas; Drug: Lilly glucagon |
| iLet bionic pancreas - Xerisol glucagon | Experimental | iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. Receives: Device: iLet bionic pancreas; Drug: Xeris Xerisol glucagon |
| iLet infusion set | Experimental | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Receives: Device: iLet infusion set |
| Contact Detach infusion set | Active comparator | The infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. Receives: Device: Contact Detach infusion set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Aggregate of Both Insulin and Glucagon Doses)
Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (aggregate of both insulin and glucagon doses) - primary outcome for iPhone-based BP using Lilly glucagon vs. iLet BP using Lilly glucagon
Measured: 8 hours
Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses).
Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (glucagon doses) - - primary outcome for iLet BP using Lilly glucagon vs. iLet BP using Xeris Xerisol glucagon
Measured: 8 hours
Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus
This applies only to the infusion set sub-study
Measured: 3.5 hours following insulin bolus
Secondary outcomes (33)
Average Continuous Glucose Monitor (CGM) Glucose
The average glucose according to continuous glucose monitor readings. This only applies to the iPhone vs. iLet BP experiments.
Measured: 8 hours
Percentage of Time in Each of the Following Ranges: < 50 mg/dl, < 60 mg/dl, <70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, >180 mg/dl, >250 mg/dl
Percentage of time subjects spent in each of these ranges based on continuous glucose monitor readings. This only applies to the iPhone vs iLet BP visits.
Measured: 8 hours
Number of Subjects With Mean CGM Glucose < 154 mg/dl
The number of subjects who achieved a mean CGM glucose < 154 mg/dl, which correlates to an estimated hemoglobin a1c of 7%, which is the ADA goal for therapy. This applies only to the iPhone vs iLet BP experiments
Measured: 8 hours
Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person)
The number of severe hypoglycemic events subjects experience. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
The average percentage of successfully delivered insulin doses. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
The average percentage of successfully delivered glucagon doses. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Average Percent Insulin Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
The average percentage of successfully issued insulin doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Average Percent Glucagon Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That a Successfully Delivered by the Pump.
The average percentage of successfully issued glucagon doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time CGM Data (New CGM Glucose Reading Captured, Dose Calculated, Dose Issued to Pumps
The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working, indicated by the presence of a CGM reading, a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured (Dose Calculated, Dose Issued to Pumps).
The percentage of time (measured in 5 minute "steps") that the bionic pancreas is working even without a CGM reading being present, indicated by a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
CGM Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM.
A measure of CGM reliability, indicating the percentage of values the CGM displayed out of the total values it should have displayed in that time. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Glucagon Total Delivery Per kg of Body Mass.
The average total glucagon delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Insulin Total Delivery Per kg of Body Mass.
The average total insulin delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Number of Episodes of Symptomatic Hypoglycemia.
Number of time subjects experienced symptoms of hypoglycemia and reported that to study staff. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Total Grams of Carbohydrate Taken for Hypoglycemia.
The total grams of carbohydrates given to subjects for treatment of hypoglycemia. This applies only to the iPhone vs iLet BP experiments.
Measured: 8 hours
Difference in Mean Nausea From VAS During the Study
This applies only the iPhone vs. iLet BP experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of nausea at timepoints during the study with 100 being the "worst possible nausea" and 0 being "no nausea".
Measured: 8 hours
Average Insulin Infusion Site Pain From VAS
This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of pain at timepoints during the study with 100 being the "worst possible pain" and 0 being "no pain".
Measured: 8 hours
Difference in Local Erythema and Edema According to the Draize Scale
This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. The draize scale assess erythema, eschar and edema using a score from 0-4, with 4 meaning a worse outcome.
Measured: 8 hours
Number of Unscheduled Infusion Set Replacements.
This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments.
Measured: 8 hours
Number of Unscheduled CGM Sensor Changes.
This applies only to the iPhone vs. iLet BP experiments
Measured: 8 hours
Insulin Area Under the Curve During the Initial 90 Minute Fasted Period
This applies only to the infusion set sub-study
Measured: 8 hours
Mean Insulin Levels During the Initial 90 Minute Fasted Period
This applies only to the infusion set sub-study
Measured: 8 hours
Difference Between Insulin Levels at Baseline and at 90 Minutes
This applies only to the infusion set sub-study
Measured: 8 hours
Tmax After the Insulin Dose
This applies only to the infusion set sub-study
Measured: 8 hours
T 1/2 Max After the Insulin Dose
This applies only to the infusion set sub-study
Measured: 8 hours
C Max After the Insulin Dose
This applies only to the infusion set sub-study
Measured: 8 hours
AUC in the First 30 Minutes After the Insulin Dose
This applies only to the infusion set sub-study
Measured: 8 hours
AUC in the First 60 Minutes After the Insulin Dose
This applies only to the infusion set sub-study
Measured: 8 hours
AUC in the First 90 Minutes After the Insulin Dose
This applies only to the infusion set sub-study
Measured: 8 hours
Terminal Half Life After the Insulin Dose
This applies only to the infusion set sub-study
Measured: 8 hours
Difference Between the Fasted PG Value and the PG Value at 90 Minutes
This applies only to the infusion set sub-study
Measured: Baseline Fasted State and 90 Minutes
Difference in the PG Prior to the Meal and Peak Post-prandial Glucose
This applies only to the infusion set sub-study
Measured: Pre-meal PG value and peak PG value during the 3.5 hours following the meal.
PG AUC in the 3.5 Hours Following the Meal
This applies only to the infusion set sub-study
Measured: 3.5 hours following the meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: The study was terminated prior to completing the planned cohorts and analysis because of problems with the infusion set resulting in inadequate insulin delivery
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 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
- 20 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
- NCT02701257
- Sponsor's protocol ID
- 2015P002773
- Status last verified
- Nov 2019
- First submitted
- 29 Feb 2016
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified IPD will be published as online supplemental material to the main paper describing the results, as we have done for all of our previous bionic pancreas studies.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas
- ClinicalTrials.gov ID
- NCT02701257
- Acronym / sponsor ID
- 2015P002773
- Conditions
- Diabetes Mellitus Type 1
- Keywords
- Bionic Pancreas, Insulin, Glucagon, Continuous Glucose Monitor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prior to completing the planned cohorts and analysis because of problems with the infusion set resulting in inadequate insulin delivery
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- Mar 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 18 Nov 2019
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 compare two different models of a wearable bionic pancreas device (the iPhone-based bionic pancreas vs. the iLet bionic pancreas) in adult participant with type 1 diabetes. Both bionic pancreas devices measure glucose levels every five minutes and then give insulin and/or glucagon automatically to regulate the blood glucose (BG).
Detailed description
The iPhone bionic pancreas has been used in earlier studies, during which volunteers used the system for up to 11 days at a time while living their normal lives at home and work. The iLet bionic pancreas has never been tested in humans. In this new study, volunteers will participate in a training visit to learn how both devices work. They will then use the iPhone-based BP for 1 day and the iLet BP for 1 day in random order using Lilly glucagon. They will then use the iLet BP for one additional day using Xeris Xerisol glucagon (a stable formulation of human glucagon).
A custom infusion set is required for this bihormonal system, to prevent future consumers from being able to accidentally swap their insulin and glucagon reservoirs and infusion sets, which could be potentially fatal. Previous experiments have demonstrated flaws in the infusion set design, requiring human experiments to be suspended and modifications to the infusion set be made. We believe the current infusion set has addressed these flaws by incorporating an anti-coring heel and a tri-beveled needle, and the infusion set sub-study is designed to isolate and study the infusion set function before further experiments using the iLet BP are conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| iPhone bionic pancreas - Lilly glucagon | Active comparator | Device: iPhone bionic pancreas, Drug: Lilly glucagoniPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. |
| iLet bionic pancreas - Lilly glucagon | Experimental | Device: iLet bionic pancreas, Drug: Lilly glucagoniLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. |
| iLet bionic pancreas - Xerisol glucagon | Experimental | Device: iLet bionic pancreas, Drug: Xeris Xerisol glucagoniLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits. |
| iLet infusion set | Experimental | Device: iLet infusion setThe infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. |
| Contact Detach infusion set | Active comparator | Device: Contact Detach infusion setThe infusion set sub-study will be testing just the experimental iLet infusion set in a crossover with the contact detach infusion set. These visits will be conducted separately from the iPhone and iLet bionic pancreas visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- iPhone and iLet BP experiments
- 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 judgment of the principal investigator)
- iLet Infusion Set Sub-Study
Key exclusion criteria (32 listed)
- iPhone and iLet BP experiments
- 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
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 |
|---|---|---|
| iPhone bionic pancreasAn experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps | Device | iPhone bionic pancreas - Lilly glucagon |
| iLet bionic pancreasAn experimental device that combines the functions of the iPhone-based bionic pancreas into one device. | Device | iLet bionic pancreas - Lilly glucagon, iLet bionic pancreas - Xerisol glucagon |
| Xeris Xerisol glucagonAlso: Xeris glucagonA stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump | Drug | iLet bionic pancreas - Xerisol glucagon |
| Lilly glucagonAlso: glucagonAn aqueous formulation of human glucagon with limited stability that must be changed daily | Drug | iLet bionic pancreas - Lilly glucagon, iPhone bionic pancreas - Lilly glucagon |
| iLet infusion setThe infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. | Device | iLet infusion set |
| Contact Detach infusion setThe infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits. | Device | Contact Detach infusion set |
Primary outcome
Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Aggregate of Both Insulin and Glucagon Doses)
Time frame: 8 hours
Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (aggregate of both insulin and glucagon doses) - primary outcome for iPhone-based BP using Lilly glucagon vs. iLet BP using Lilly glucagon
Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses).
Time frame: 8 hours
Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (glucagon doses) - - primary outcome for iLet BP using Lilly glucagon vs. iLet BP using Xeris Xerisol glucagon
Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus
Time frame: 3.5 hours following insulin bolus
This applies only to the infusion set sub-study
33 secondary outcomes
Average Continuous Glucose Monitor (CGM) Glucose
Time frame: 8 hours
Percentage of Time in Each of the Following Ranges: < 50 mg/dl, < 60 mg/dl, <70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, >180 mg/dl, >250 mg/dl
Time frame: 8 hours
Number of Subjects With Mean CGM Glucose < 154 mg/dl
Time frame: 8 hours
Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person)
Time frame: 8 hours
Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
Time frame: 8 hours
Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
Time frame: 8 hours
Average Percent Insulin Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
Time frame: 8 hours
Average Percent Glucagon Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That a Successfully Delivered by the Pump.
Time frame: 8 hours
Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time CGM Data (New CGM Glucose Reading Captured, Dose Calculated, Dose Issued to Pumps
Time frame: 8 hours
Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured (Dose Calculated, Dose Issued to Pumps).
Time frame: 8 hours
CGM Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM.
Time frame: 8 hours
Glucagon Total Delivery Per kg of Body Mass.
Time frame: 8 hours
Insulin Total Delivery Per kg of Body Mass.
Time frame: 8 hours
Number of Episodes of Symptomatic Hypoglycemia.
Time frame: 8 hours
Total Grams of Carbohydrate Taken for Hypoglycemia.
Time frame: 8 hours
Difference in Mean Nausea From VAS During the Study
Time frame: 8 hours
Average Insulin Infusion Site Pain From VAS
Time frame: 8 hours
Difference in Local Erythema and Edema According to the Draize Scale
Time frame: 8 hours
Number of Unscheduled Infusion Set Replacements.
Time frame: 8 hours
Number of Unscheduled CGM Sensor Changes.
Time frame: 8 hours
Insulin Area Under the Curve During the Initial 90 Minute Fasted Period
Time frame: 8 hours
Mean Insulin Levels During the Initial 90 Minute Fasted Period
Time frame: 8 hours
Difference Between Insulin Levels at Baseline and at 90 Minutes
Time frame: 8 hours
Tmax After the Insulin Dose
Time frame: 8 hours
T 1/2 Max After the Insulin Dose
Time frame: 8 hours
C Max After the Insulin Dose
Time frame: 8 hours
AUC in the First 30 Minutes After the Insulin Dose
Time frame: 8 hours
AUC in the First 60 Minutes After the Insulin Dose
Time frame: 8 hours
AUC in the First 90 Minutes After the Insulin Dose
Time frame: 8 hours
Terminal Half Life After the Insulin Dose
Time frame: 8 hours
Difference Between the Fasted PG Value and the PG Value at 90 Minutes
Time frame: Baseline Fasted State and 90 Minutes
Difference in the PG Prior to the Meal and Peak Post-prandial Glucose
Time frame: Pre-meal PG value and peak PG value during the 3.5 hours following the meal.
PG AUC in the 3.5 Hours Following the Meal
Time frame: 3.5 hours following the meal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified IPD will be published as online supplemental material to the main paper describing the results, as we have done for all of our previous bionic pancreas studies.
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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 iPhone bionic pancreas, iLet bionic pancreas and Xeris Xerisol glucagon in people with Diabetes Mellitus Type 1, 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 32 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: stopped early, as of the sponsor's last update on 18 Nov 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 18 Nov 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?
Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Aggregate of Both Insulin and Glucagon Doses) (time frame: 8 hours). The study lists 3 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 18 Nov 2019.