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Insulin Analog

Bionic Pancreas - BC222 insulin lispro for Type 1 Diabetes

Phase 2 & 3
Waitlist Available
Led By Steven J Russell, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study Summary

This trial will test a bionic pancreas in people with diabetes, using different types of insulin.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Continuous Glucose Monitor (CGM) Glucose
Percentage of Time Spent With CGM Glucose < 54 mg/dl
Secondary outcome measures
Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day
Mean Post Prandial Excursion
Number of Symptomatic Hypoglycemic Events Per Day
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Bionic Pancreas - NovologExperimental Treatment2 Interventions
Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.
Group II: Bionic Pancreas - HumalogExperimental Treatment2 Interventions
Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.
Group III: Bionic Pancreas - BC222 insulin lisproExperimental Treatment2 Interventions
Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bionic Pancreas
2017
N/A
~190
Insulin human
FDA approved
Insulin lispro
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,471 Total Patients Enrolled
Boston UniversityOTHER
454 Previous Clinical Trials
9,941,550 Total Patients Enrolled
Steven J Russell, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
16 Previous Clinical Trials
321 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas
Steven J. Russell, MD, PhD 2019. "Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03262116.
~3 spots leftby Apr 2025
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