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Simplified Onboarding in Adults With Type 2 Diabetes

NCT07070830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-01-30

No results posted yet for this study

Summary

This is an outpatient study testing different starting doses of insulin in participants with type 2 diabetes. Participants will manage their diabetes using the Omnipod M System. The system is comprised of an Omnipod M Pod, an Omnipod M Controller, and will be used with a Dexcom G6 continuous glucose monitoring sensor (CGM). The main objectives of the study are to evaluate the safety and tolerability of different starting doses of insulin using the Omnipod M System.

There is a precursory evaluation before the main, randomized trial. Participation in the precursory evaluation could last up to 12 weeks and participation in the randomized trial could last up to 6 weeks. During both the evaluation and the randomized trial, participants will manage their diabetes using the Omnipod M System in Automated Mode.

An optional 12-weeks of continued Omnipod M System use is available upon completion of the randomized trial.

Conditions

Interventions

DEVICE

Active Comparator: Omnipod M System with lower starting dose

Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system

DEVICE

Active Comparator: Omnipod M System with higher starting dose

Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system

Sponsors & Collaborators

  • Insulet Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2026-01-06
Completion
2026-01-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070830 on ClinicalTrials.gov