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Automated Insulin Delivery System

Bionic Pancreas for Diabetes Mellitus

N/A
Waitlist Available
Led By Sean M Oser, MD, MPH
Research Sponsored by University of Colorado, Denver
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 bp arm days 3-14
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a device that automatically manages insulin for adults with type 1 diabetes. It includes both new and experienced users to see how well it works. The device keeps blood sugar stable by adjusting insulin levels as needed. Automated insulin delivery systems have shown potential to improve blood sugar control and quality of life in people with type 1 diabetes.

Eligible Conditions
  • Diabetes Mellitus
  • Type 1 Diabetes
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~bp arm days 3-14
This trial's timeline: 3 weeks for screening, Varies for treatment, and bp arm days 3-14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of individuals with mean CGM glucose <183 mg/dL (corresponding to an estimated HbA1c of <8.0%) on days 3-14, by group.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: PC-TH-UCExperimental Treatment1 Intervention
Random-order cross-over participants on USUAL CARE managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
Group II: PC-TH-BPExperimental Treatment2 Interventions
Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
Group III: PC-IP-BPExperimental Treatment1 Intervention
Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
Group IV: EN-TH-UCExperimental Treatment1 Intervention
Random-order cross-over participants on USUAL CARE managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
Group V: EN-TH-BPExperimental Treatment2 Interventions
Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
Group VI: EN-IP-BPExperimental Treatment1 Intervention
Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
Group VII: PC-IP-UCActive Control1 Intervention
Random-order cross-over participants on USUAL CARE intervention managed by PRIMARY CARE with IN-PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
Group VIII: EN-IP-UCActive Control1 Intervention
Random-order cross-over participants on USUAL CARE managed by ENDOCRINOLOGY with IN-PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bionic Pancreas
2017
N/A
~190

Find a Location

Who is running the clinical trial?

Beta Bionics, Inc.Industry Sponsor
6 Previous Clinical Trials
637 Total Patients Enrolled
4 Trials studying Diabetes Mellitus
475 Patients Enrolled for Diabetes Mellitus
University of Colorado, DenverLead Sponsor
1,798 Previous Clinical Trials
2,797,144 Total Patients Enrolled
108 Trials studying Diabetes Mellitus
36,933 Patients Enrolled for Diabetes Mellitus
Massachusetts General HospitalOTHER
3,000 Previous Clinical Trials
13,308,552 Total Patients Enrolled
52 Trials studying Diabetes Mellitus
664,781 Patients Enrolled for Diabetes Mellitus
~15 spots leftby Oct 2025
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