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Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas
1 other identifier
interventional
20
1 country
1
Brief Summary
Subjects will participate in three weeks of the bionic pancreas in the insulin-only configuration. Each week, subjects will use a different rapid acting insulin analog -- Humalog, Novolog, or BC222 insulin lispro -- in a randomized cross-over order.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2017
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedStudy Start
First participant enrolled
March 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2019
CompletedResults Posted
Study results publicly available
December 9, 2022
CompletedDecember 9, 2022
November 1, 2022
4 months
August 23, 2017
February 24, 2022
November 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Average Continuous Glucose Monitor (CGM) Glucose
The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm
7 days
Percentage of Time Spent With CGM Glucose < 54 mg/dl
The amount of time the subject spent in the hypoglycemic range \< 54 mg/dl as measured by the continuous glucose monitor during each arm
7 days
Secondary Outcomes (6)
Percentage of Time Spent Within Each of the Following Ranges:
7 days
Within Day Coefficient of Variation
7 days
Mean Post Prandial Excursion
7 days
Number of Symptomatic Hypoglycemic Events Per Day
7 days
Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day
7 days
- +1 more secondary outcomes
Study Arms (3)
Bionic Pancreas - Humalog
EXPERIMENTALSubjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.
Bionic Pancreas - Novolog
EXPERIMENTALSubjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.
Bionic Pancreas - BC222 insulin lispro
EXPERIMENTALSubjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.
Interventions
Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.
Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.
Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.
The insulin-only bionic pancreas will be used in all three arms of the study
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years and have had clinical type 1 diabetes for at least one year
- Diabetes managed using an insulin pump for ≥ 6 months
- Have used a CGM for at least one cumulative month over the last 12 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)
- Willing to remain within a 250 mile radius of MGH. No air travel will be allowed, and subjects will still be expected to follow the visit schedule as described.
- Willing to wear one Dexcom CGM sensor, and one leur-lock compatible infusion set that must be replaced every other day
- Have a mobile phone they will have access to at all times during the study for making contact with study staff
You may not qualify if:
- 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 Subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.
- Acceptable contraception methods include: Oral contraceptive pill (OCP), Intrauterine Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as Implanon, Nexplanon), Vaginal ring (such as NuvaRing), Progestin shot (such as Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis
- Current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days) or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
- Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of beta blockers will be allowed as long as the dose is stable and the subject does not meet the criteria for hypoglycemia unawareness while taking that stable dose, but use of benzodiazepines or narcotics or other central nervous system depressants, even if by prescription, may be excluded according to the judgment of the principal investigator)
- Renal failure requiring dialysis
- Estimated Glomerular filtration rate \<15 mL/min/1.732
- Personal history of cystic fibrosis, severe pancreatitis, pancreatic tumor, pancreatectomy or any other pancreatic disease leading to diabetes mellitus.
- 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 stroke15. Recent history of diabetic ketoacidosis (DKA) or severe hypoglycemia in the last 6 months. Severe hypoglycemia is defined as an event that required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that he/she was unable to treat himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma.
- History of more than 1 episode of DKA requiring hospitalization in the last 2 years
- History of more than 1 episode of severe hypoglycemia in the last year.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Boston Universitycollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated, so only a limited number of participants completed all three interventions.
Results Point of Contact
- Title
- Dr Steven J. Russell, MD, PhD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Steven J Russell, MD, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be blinded to the type of insulin used in the iLet bionic pancreas each arm of the study.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 23, 2017
First Posted
August 25, 2017
Study Start
March 19, 2019
Primary Completion
July 23, 2019
Study Completion
July 23, 2019
Last Updated
December 9, 2022
Results First Posted
December 9, 2022
Record last verified: 2022-11