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Trial · Interventional

TerminatedNot applicableResults postedRegistry data

The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas

Overview

Status
Terminated
Phase
Not applicable
Enrollment
20 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Mar 2016
Primary completion
May 2018
Completion
May 2018
First posted
8 Mar 2016 (estimated)
Last update posted
18 Nov 2019
Conditions
Diabetes Mellitus Type 1

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. N/A

    The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas

    NCT02701257

    Mar 2016 to May 2018

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • iPhone bionic pancreasDevice
  • iLet bionic pancreasDevice
  • Xeris Xerisol glucagonDrug
  • Lilly glucagonDrug
  • iLet infusion setDevice
  • Contact Detach infusion setDevice

Arms5

  • Active comparator

    iPhone bionic pancreas - Lilly glucagon

    iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.

  • Experimental

    iLet bionic pancreas - Lilly glucagon

    iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.

  • Experimental

    iLet bionic pancreas - Xerisol glucagon

    iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.

  • Experimental

    iLet infusion set

    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.

  • Active comparator

    Contact Detach infusion set

    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.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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

  2. Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses).

    Time frame · 8 hours

    Registry description

    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

  3. Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus

    Time frame · 3.5 hours following insulin bolus

    Registry description

    This applies only to the infusion set sub-study

Secondary outcomes(20)
  1. Average Continuous Glucose Monitor (CGM) Glucose

    Time frame · 8 hours

    Registry description

    The average glucose according to continuous glucose monitor readings. This only applies to the iPhone vs. iLet BP experiments.

  2. 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

    Registry description

    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.

  3. Number of Subjects With Mean CGM Glucose < 154 mg/dl

    Time frame · 8 hours

    Registry description

    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

  4. Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person)

    Time frame · 8 hours

    Registry description

    The number of severe hypoglycemic events subjects experience. This applies only to the iPhone vs iLet BP experiments.

  5. Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

    Time frame · 8 hours

    Registry description

    The average percentage of successfully delivered insulin doses. This applies only to the iPhone vs iLet BP experiments.

  6. Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

    Time frame · 8 hours

    Registry description

    The average percentage of successfully delivered glucagon doses. This applies only to the iPhone vs iLet BP experiments.

  7. 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

    Registry description

    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.

  8. 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

    Registry description

    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.

  9. 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

    Registry description

    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.

  10. 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

    Registry description

    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.

  11. CGM Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM.

    Time frame · 8 hours

    Registry description

    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.

  12. Glucagon Total Delivery Per kg of Body Mass.

    Time frame · 8 hours

    Registry description

    The average total glucagon delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.

  13. Insulin Total Delivery Per kg of Body Mass.

    Time frame · 8 hours

    Registry description

    The average total insulin delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.

  14. Number of Episodes of Symptomatic Hypoglycemia.

    Time frame · 8 hours

    Registry description

    Number of time subjects experienced symptoms of hypoglycemia and reported that to study staff. This applies only to the iPhone vs iLet BP experiments.

  15. Total Grams of Carbohydrate Taken for Hypoglycemia.

    Time frame · 8 hours

    Registry description

    The total grams of carbohydrates given to subjects for treatment of hypoglycemia. This applies only to the iPhone vs iLet BP experiments.

  16. Difference in Mean Nausea From VAS During the Study

    Time frame · 8 hours

    Registry description

    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".

  17. Average Insulin Infusion Site Pain From VAS

    Time frame · 8 hours

    Registry description

    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".

  18. Difference in Local Erythema and Edema According to the Draize Scale

    Time frame · 8 hours

    Registry description

    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.

  19. Number of Unscheduled Infusion Set Replacements.

    Time frame · 8 hours

    Registry description

    This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments.

  20. Number of Unscheduled CGM Sensor Changes.

    Time frame · 8 hours

    Registry description

    This applies only to the iPhone vs. iLet BP experiments

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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)

GroupValue (percentage of doses delivered)Spread
iPhone Bionic Pancreas - Lilly Glucagon94.69.2
iLet Bionic Pancreas - Lilly Glucagon95.012.3
iLet Bionic Pancreas - Xerisol Glucagonnot posted–
iLet Infusion Setnot posted–
Contact Detach Infusion Setnot posted–
Primary outcomeMean· 8 hours

Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses).

GroupValue (percentage of doses)Spread
iPhone Bionic Pancreas - Lilly Glucagon96.66.8
iLet Bionic Pancreas - Lilly Glucagon100.00.5
iLet Bionic Pancreas - Xerisol Glucagonnot posted–
iLet Infusion Setnot posted–
Contact Detach Infusion Setnot posted–
Primary outcome· 3.5 hours following insulin bolus

Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus

GroupValue
iPhone Bionic Pancreas - Lilly Glucagonnot posted
iLet Bionic Pancreas - Lilly Glucagonnot posted
iLet Bionic Pancreas - Xerisol Glucagonnot posted
iLet Infusion Setnot posted
Contact Detach Infusion Setnot posted
Secondary and other outcome results(5)
Secondary outcomeMean· 8 hours

Average Continuous Glucose Monitor (CGM) Glucose

GroupValue (mg/dl)Spread
iPhone Bionic Pancreas - Lilly Glucagon179.237.5
iLet Bionic Pancreas - Lilly Glucagon251.280.0
iLet Bionic Pancreas - Xerisol Glucagonnot posted–
iLet Infusion Setnot posted–
Contact Detach Infusion Setnot posted–
Secondary outcomeMean· 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

GroupValue (percentage of time)Spread
iPhone Bionic Pancreas - Lilly Glucagon0.00.0
iLet Bionic Pancreas - Lilly Glucagon0.361.07
iLet Bionic Pancreas - Xerisol Glucagonnot posted–
iLet Infusion Setnot posted–
Contact Detach Infusion Setnot posted–
Secondary outcomeCount of participants· 8 hours

Number of Subjects With Mean CGM Glucose < 154 mg/dl

GroupValue (Participants)
iPhone Bionic Pancreas - Lilly Glucagon1
iLet Bionic Pancreas - Lilly Glucagon1
iLet Bionic Pancreas - Xerisol Glucagonnot posted
iLet Infusion Setnot posted
Contact Detach Infusion Setnot posted
Secondary outcomeNumber· 8 hours

Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person)

GroupValue (events)
iPhone Bionic Pancreas - Lilly Glucagon0
iLet Bionic Pancreas - Lilly Glucagon0
iLet Bionic Pancreas - Xerisol Glucagonnot posted
iLet Infusion Setnot posted
Contact Detach Infusion Setnot posted
Secondary outcomeMean· 8 hours

Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

GroupValue (percentage of doses)Spread
iPhone Bionic Pancreas - Lilly Glucagon94.010.7
iLet Bionic Pancreas - Lilly Glucagon95.813.3
iLet Bionic Pancreas - Xerisol Glucagonnot posted–
iLet Infusion Setnot posted–
Contact Detach Infusion Setnot posted–

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
iPhone Bionic Pancreas - Lilly GlucagoniPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits. iPhone bionic pancreas: An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily0 / 90 / 90 / 9
iLet Bionic Pancreas - 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: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Lilly glucagon: An aqueous formulation of human glucagon with limited stability that must be changed daily0 / 120 / 127 / 12
iLet Bionic Pancreas - 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 bionic pancreas: An experimental device that combines the functions of the iPhone-based bionic pancreas into one device. Xeris Xerisol 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 pump0 / 00 / 00 / 0
iLet Infusion SetiLet infusion set: 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.0 / 50 / 50 / 5
Contact DetachContact Detach infusion set: 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.0 / 70 / 70 / 7

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 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 Exclusion Criteria: 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) * 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

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