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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

Study Summary

This trial will test how well the iLet bionic pancreas works for people with type 1 diabetes who have never used an insulin pump before, and will compare in-person training and follow-up to training and follow-up via telehealth.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of individuals with mean CGM glucose <183 mg/dL (corresponding to an estimated HbA1c of <8.0%) on days 3-14, by group.
Secondary outcome measures
Mean CGM glucose on days 3-14
Percentage of individuals with mean CGM glucose <154 mg/dL (corresponding to an estimated HbA1c of <7.0%) on days 3-14, by group.
Percentage of time with CGM glucose <54 mg/dl on days 3-14
+1 more

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
5 Previous Clinical Trials
487 Total Patients Enrolled
4 Trials studying Diabetes Mellitus
475 Patients Enrolled for Diabetes Mellitus
University of Colorado, DenverLead Sponsor
1,742 Previous Clinical Trials
2,152,705 Total Patients Enrolled
106 Trials studying Diabetes Mellitus
36,796 Patients Enrolled for Diabetes Mellitus
Massachusetts General HospitalOTHER
2,937 Previous Clinical Trials
13,198,996 Total Patients Enrolled
52 Trials studying Diabetes Mellitus
665,066 Patients Enrolled for Diabetes Mellitus

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
Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth
2022. "Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05168657.
~18 spots leftby May 2025
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