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A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes

NCT05785832 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2026-05-22

Study results available
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Summary

A randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ+ technology in adults with type 2 diabetes using basal-bolus insulin therapy.

Conditions

  • Type 2 Diabetes Treated With Insulin

Interventions

DEVICE

t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM

The t:slim X2 insulin pump with Control-IQ+ technology, used with the Dexcom G6 CGM.

DEVICE

Standard Therapy plus continuous glucose monitoring (CGM)

Standard therapy is continuation of pre-study basal-bolus insulin delivery method, plus use of Dexcom G6 CGM.

Sponsors & Collaborators

  • Jaeb Center for Health Research

    collaborator OTHER

  • Tandem Diabetes Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Jordan Pinsker, MD · Tandem Diabetes Care

  • Yogish Kudva, MBBS · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-09-24
Completion
2024-09-24
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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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 NCT05785832 on ClinicalTrials.gov