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The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.

NCT06111508 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-04

Study results available
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Summary

The goal of this clinical trial is to compare the effect of a continuous glucose monitor (CGM) based titration algorithm to standard titration by self-monitoring blood glucose (SMBG) in participants with Type 2 Diabetes already using long acting insulin. The comparison aims to study the difference in glycemic control between the two therapies. Participants will be followed for 18 weeks and will be provided with Degludec insulin, insulin pen, and a CGM (Dexcom G6).

Conditions

Interventions

DEVICE

Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs

A Continuous Glucose Monitoring (CGM)-based once weekly titration algorithm of basal insulin as implemented in DiAs Cloud platform

Sponsors & Collaborators

Principal Investigators

  • Ralf M Nass, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2024-09-13
Completion
2024-09-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT06111508 on ClinicalTrials.gov