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

Primary Purpose

Diabetes Mellitus Type 1

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iPhone bionic pancreas
iLet bionic pancreas
Xeris Xerisol glucagon
Lilly glucagon
iLet infusion set
Contact Detach infusion set
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 1 focused on measuring Bionic Pancreas, Insulin, Glucagon, Continuous Glucose Monitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MGH Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

iPhone bionic pancreas - Lilly glucagon

iLet bionic pancreas - Lilly glucagon

iLet bionic pancreas - Xerisol glucagon

iLet infusion set

Contact Detach infusion set

Arm Description

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

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

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.

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.

Outcomes

Primary Outcome Measures

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
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
Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus
This applies only to the infusion set sub-study

Secondary Outcome Measures

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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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".
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".
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.
Number of Unscheduled Infusion Set Replacements.
This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments.
Number of Unscheduled CGM Sensor Changes.
This applies only to the iPhone vs. iLet BP experiments
Insulin Area Under the Curve During the Initial 90 Minute Fasted Period
This applies only to the infusion set sub-study
Mean Insulin Levels During the Initial 90 Minute Fasted Period
This applies only to the infusion set sub-study
Difference Between Insulin Levels at Baseline and at 90 Minutes
This applies only to the infusion set sub-study
Tmax After the Insulin Dose
This applies only to the infusion set sub-study
T 1/2 Max After the Insulin Dose
This applies only to the infusion set sub-study
C Max After the Insulin Dose
This applies only to the infusion set sub-study
AUC in the First 30 Minutes After the Insulin Dose
This applies only to the infusion set sub-study
AUC in the First 60 Minutes After the Insulin Dose
This applies only to the infusion set sub-study
AUC in the First 90 Minutes After the Insulin Dose
This applies only to the infusion set sub-study
Terminal Half Life After the Insulin Dose
This applies only to the infusion set sub-study
Difference Between the Fasted PG Value and the PG Value at 90 Minutes
This applies only to the infusion set sub-study
Difference in the PG Prior to the Meal and Peak Post-prandial Glucose
This applies only to the infusion set sub-study
PG AUC in the 3.5 Hours Following the Meal
This applies only to the infusion set sub-study

Full Information

First Posted
February 29, 2016
Last Updated
November 15, 2019
Sponsor
Massachusetts General Hospital
Collaborators
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT02701257
Brief Title
The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas
Official Title
The iLet Introduction Study: A Feasibility Study of the iLet, a Fully Integrated Bihormonal Bionic Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why 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
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boston University

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1
Keywords
Bionic Pancreas, Insulin, Glucagon, Continuous Glucose Monitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iPhone bionic pancreas - Lilly glucagon
Arm Type
Active Comparator
Arm Description
iPhone based bionic pancreas using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
Arm Title
iLet bionic pancreas - Lilly glucagon
Arm Type
Experimental
Arm Description
iLet Bionic Pancreas using using insulin lispro and Lilly glucagon. These visits will be conducted separately from the infusion set sub-study visits.
Arm Title
iLet bionic pancreas - Xerisol glucagon
Arm Type
Experimental
Arm Description
iLet Bionic Pancreas using using insulin lispro and Xeris Xerisol glucagon. These visits will be conducted separately from the infusion set sub-study visits.
Arm Title
iLet infusion set
Arm Type
Experimental
Arm Description
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.
Arm Title
Contact Detach infusion set
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
iPhone bionic pancreas
Intervention Description
An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
Intervention Type
Device
Intervention Name(s)
iLet bionic pancreas
Intervention Description
An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
Intervention Type
Drug
Intervention Name(s)
Xeris Xerisol glucagon
Other Intervention Name(s)
Xeris glucagon
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lilly glucagon
Other Intervention Name(s)
glucagon
Intervention Description
An aqueous formulation of human glucagon with limited stability that must be changed daily
Intervention Type
Device
Intervention Name(s)
iLet infusion set
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Contact Detach infusion set
Intervention Description
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 Measure Information:
Title
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)
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
Time Frame
8 hours
Title
Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses).
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
Time Frame
8 hours
Title
Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus
Description
This applies only to the infusion set sub-study
Time Frame
3.5 hours following insulin bolus
Secondary Outcome Measure Information:
Title
Average Continuous Glucose Monitor (CGM) Glucose
Description
The average glucose according to continuous glucose monitor readings. This only applies to the iPhone vs. iLet BP experiments.
Time Frame
8 hours
Title
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
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.
Time Frame
8 hours
Title
Number of Subjects With Mean CGM Glucose < 154 mg/dl
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
Time Frame
8 hours
Title
Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person)
Description
The number of severe hypoglycemic events subjects experience. This applies only to the iPhone vs iLet BP experiments.
Time Frame
8 hours
Title
Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
Description
The average percentage of successfully delivered insulin doses. This applies only to the iPhone vs iLet BP experiments.
Time Frame
8 hours
Title
Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
Description
The average percentage of successfully delivered glucagon doses. This applies only to the iPhone vs iLet BP experiments.
Time Frame
8 hours
Title
Average Percent Insulin Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
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.
Time Frame
8 hours
Title
Average Percent Glucagon Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That a Successfully Delivered by the Pump.
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.
Time Frame
8 hours
Title
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
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.
Time Frame
8 hours
Title
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).
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.
Time Frame
8 hours
Title
CGM Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM.
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.
Time Frame
8 hours
Title
Glucagon Total Delivery Per kg of Body Mass.
Description
The average total glucagon delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.
Time Frame
8 hours
Title
Insulin Total Delivery Per kg of Body Mass.
Description
The average total insulin delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.
Time Frame
8 hours
Title
Number of Episodes of Symptomatic Hypoglycemia.
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.
Time Frame
8 hours
Title
Total Grams of Carbohydrate Taken for Hypoglycemia.
Description
The total grams of carbohydrates given to subjects for treatment of hypoglycemia. This applies only to the iPhone vs iLet BP experiments.
Time Frame
8 hours
Title
Difference in Mean Nausea From VAS During the Study
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".
Time Frame
8 hours
Title
Average Insulin Infusion Site Pain From VAS
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".
Time Frame
8 hours
Title
Difference in Local Erythema and Edema According to the Draize Scale
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.
Time Frame
8 hours
Title
Number of Unscheduled Infusion Set Replacements.
Description
This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments.
Time Frame
8 hours
Title
Number of Unscheduled CGM Sensor Changes.
Description
This applies only to the iPhone vs. iLet BP experiments
Time Frame
8 hours
Title
Insulin Area Under the Curve During the Initial 90 Minute Fasted Period
Description
This applies only to the infusion set sub-study
Time Frame
8 hours
Title
Mean Insulin Levels During the Initial 90 Minute Fasted Period
Description
This applies only to the infusion set sub-study
Time Frame
8 hours
Title
Difference Between Insulin Levels at Baseline and at 90 Minutes
Description
This applies only to the infusion set sub-study
Time Frame
8 hours
Title
Tmax After the Insulin Dose
Description
This applies only to the infusion set sub-study
Time Frame
8 hours
Title
T 1/2 Max After the Insulin Dose
Description
This applies only to the infusion set sub-study
Time Frame
8 hours
Title
C Max After the Insulin Dose
Description
This applies only to the infusion set sub-study
Time Frame
8 hours
Title
AUC in the First 30 Minutes After the Insulin Dose
Description
This applies only to the infusion set sub-study
Time Frame
8 hours
Title
AUC in the First 60 Minutes After the Insulin Dose
Description
This applies only to the infusion set sub-study
Time Frame
8 hours
Title
AUC in the First 90 Minutes After the Insulin Dose
Description
This applies only to the infusion set sub-study
Time Frame
8 hours
Title
Terminal Half Life After the Insulin Dose
Description
This applies only to the infusion set sub-study
Time Frame
8 hours
Title
Difference Between the Fasted PG Value and the PG Value at 90 Minutes
Description
This applies only to the infusion set sub-study
Time Frame
Baseline Fasted State and 90 Minutes
Title
Difference in the PG Prior to the Meal and Peak Post-prandial Glucose
Description
This applies only to the infusion set sub-study
Time Frame
Pre-meal PG value and peak PG value during the 3.5 hours following the meal.
Title
PG AUC in the 3.5 Hours Following the Meal
Description
This applies only to the infusion set sub-study
Time Frame
3.5 hours following the meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Russell, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH Diabetes Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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