Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    xerisol

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02701257
Recruitment Status : Terminated
First Posted : March 8, 2016
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital

Brief 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. Both bionic pancreas devices measure glucose levels every five minutes and then give insulin and/or glucagon automatically to regulate the blood glucose (BG).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Device: iPhone bionic pancreas Device: iLet bionic pancreas Drug: Xeris Xerisol glucagon Drug: Lilly glucagon Device: iLet infusion set Device: Contact Detach infusion set Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas
Study Start Date : March 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: 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

Drug: Lilly glucagon
An aqueous formulation of human glucagon with limited stability that must be changed daily
Other Name: glucagon

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.
Device: iLet bionic pancreas
An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.

Drug: Lilly glucagon
An aqueous formulation of human glucagon with limited stability that must be changed daily
Other Name: glucagon

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.
Device: iLet bionic pancreas
An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.

Drug: 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 pump
Other Name: Xeris glucagon

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.
Device: iLet 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.

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.
Device: Contact 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.




Primary Outcome Measures :
  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: 1 day ]
    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: 1 day ]
    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: Infusion set sub-study; 3.5 hours following insulin bolus ]
    This applies only to the infusion set sub-study


Secondary Outcome Measures :
  1. Average continuous glucose monitor (CGM) glucose [ Time Frame: 1 day ]
    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: 1 day ]
    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. Percentage of subjects with mean CGM glucose < 154 mg/dl [ Time Frame: 1 day ]
    The percentage 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: 1 day ]
    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: 1 day ]
    The average number 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: 1 day ]
    The average number 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: 1 day ]
    The average number 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: 1 day ]
    The average number 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: 1 day ]
    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: 1 day ]
    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: 1 day ]
    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: 1 day ]
    The 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: 1 day ]
    The 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: 1 day ]
    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: 1 day ]
    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: 1 day ]
    This applies only the iPhone vs. iLet BP experiments.

  17. Difference in Infusion site pain from VAS [ Time Frame: 1 day ]
    This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments.

  18. Difference in local erythema and edema according to the Draize scale [ Time Frame: 1 day ]
    This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments.

  19. Number of unscheduled infusion set replacements. [ Time Frame: 1 day ]
    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: 1 day ]
    This applies only to the iPhone vs. iLet BP experiments

  21. Insulin area under the curve during the initial 90 minute fasted period [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  22. Mean insulin levels during the initial 90 minute fasted period [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  23. Difference between insulin levels at baseline and at 90 minutes [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  24. Tmax after the insulin dose [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  25. T 1/2 max after the insulin dose [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  26. C max after the insulin dose [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  27. AUC in the first 30 minutes after the insulin dose [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  28. AUC in the first 60 minutes after the insulin dose [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  29. AUC in the first 90 minutes after the insulin dose [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  30. Terminal half life after the insulin dose [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  31. Difference between the fasted PG value and the PG value at 90 minutes [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  32. Difference in the PG prior to the meal and peak post-prandial glucose [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study

  33. PG AUC in the 3.5 hours following the meal [ Time Frame: 1 day ]
    This applies only to the infusion set sub-study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701257


Locations
Layout table for location information
United States, Massachusetts
MGH Diabetes Research Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Boston University
Investigators
Layout table for investigator information
Principal Investigator: Steven J Russell, MD, PhD Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Steven J. Russell, MD, PhD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02701257     History of Changes
Other Study ID Numbers: 2015P002773
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Steven J. Russell, MD, PhD, Massachusetts General Hospital:
Bionic Pancreas
Insulin
Glucagon
Continuous Glucose Monitor

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Pancrelipase
Pancreatin
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins