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Automated Insulin Delivery System

Bionic Pancreas for Diabetes

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
Type 1 Diabetes
Brittle diabetes
Diabetic ketoacidosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ bp arm days 3-14

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.

Secondary study objectives

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

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

Group I: PC-TH-UC first, Then BPExperimental Treatment1 Intervention

Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms.

Group II: PC-TH-BP first, Then UCExperimental Treatment1 Intervention

Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms.

Group III: PC-IP-UC first, Then BPExperimental Treatment1 Intervention

Random-order cross-over participants managed by PRIMARY CARE with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms.

Group IV: PC-IP-BP first, Then UCExperimental Treatment1 Intervention

Random-order cross-over participants managed by PRIMARY CARE with IN PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms.

Group V: EN-TH-UC first, Then BPExperimental Treatment1 Intervention

Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms.

Group VI: EN-TH-BP first, Then UCExperimental Treatment1 Intervention

Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms.

Group VII: EN-IP-UC first, Then BPExperimental Treatment1 Intervention

Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms.

Group VIII: EN-IP-BP first, Then UCExperimental Treatment1 Intervention

Random-order cross-over participants managed by ENDOCRINOLOGY with IN PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bionic Pancreas

2017

N/A

~190

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