# The Insulin-Only Bionic Pancreas Pivotal Trial

> **NCT04200313** · NA · COMPLETED · sponsor: **Jaeb Center for Health Research** · enrollment: 440 (actual)

## Conditions studied

- Diabetes Mellitus
- Type 1 Diabetes
- Diabetes Mellitus, Type 1

## Interventions

- **COMBINATION_PRODUCT:** Bionic Pancreas (BP) with Aspart or Lispro
- **COMBINATION_PRODUCT:** Bionic Pancreas with Fiasp (BPFiasp)
- **OTHER:** Usual Care (UC)
- **OTHER:** BP Guidance Insulin Dosing

## Key facts

- **NCT ID:** NCT04200313
- **Lead sponsor:** Jaeb Center for Health Research
- **Sponsor class:** OTHER
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-03-31
- **Primary completion:** 2021-10-30
- **Final completion:** 2022-01-14
- **Target enrollment:** 440 (ACTUAL)
- **Last updated:** 2025-02-20

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04200313

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04200313, "The Insulin-Only Bionic Pancreas Pivotal Trial". Retrieved via AI Analytics 2026-05-30 from https://api.ai-analytics.org/clinical/NCT04200313. Licensed CC0.

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