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

Part of paid clinical trials in New York, New York.

Sponsor
University of Virginia
Study ID
NCT06111508
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Nov 29, 2023
Status verified
Feb 2026
Primary completion
Sep 13, 2024
Completion
Sep 16, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Continuous Glucose Monitoring (CGM) based Titration
    The CGM-based titration algorithm will run on the Diabetes Assistant and Amazon Web Services (AWS) platform (DiAs-Cloud). DiAs-Cloud enables the seamless integration of a smart phone application and AWS server architecture to enable data capture, dose computation, review by the clinical team, and communication to study participants. For dose computation the algorithm is comprised of three components; titration glucose level, personalized target, and safety hypoglycemia feature.
  • No Intervention: Standard Self-Monitoring Blood Glucose (SMBG) Titration
    The SMBG-based titration algorithm will run on the Diabetes Assistant and Amazon Web Services (AWS) platform (DiAs-Cloud). DiAs-Cloud enables the seamless integration of a smart phone application and AWS server architecture to enable data capture, dose computation, review by the clinical team, and communication to study participants. Participants in the standard SMBG based titration group will wear a blinded CGM during the whole study. The total daily basal insulin dose will be converted 1:1 to Degludec. Algorithm informed dose changes will be made once weekly and checked by study physician.

Primary Outcome Measure

Change in Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) [ Time Frame: From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University of VirginiaCharlottesvilleVirginia22903-

Find similar trials in New York, NY

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Icahn School of Medicine at Mount Sinai· New York, NYUniversity of Virginia· Charlottesville, VA

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