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NCT06111508Completed

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

An Exploratory 16-Week Pilot Study of the Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin, With or Without Non-Insulin Antidiabetic Drugs, in Type 2 Diabetes Mellitus Participants Treated With Basal Insulin.

Source: ClinicalTrials.gov · Last updated 4 Mar 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
26 Oct 2023
Start date
29 Nov 2023
Primary completion date
13 Sept 2024
Lead sponsor
University of Virginia
NCT number
NCT06111508

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 29 Nov 2023 to the primary completion date, 13 Sept 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days of the screening visit
  • Current/prior use of CGM within 30 days of the screening visit
  • Any planned surgery or procedures where basal insulin would be decreased or held in anticipation

Other illness

  • Hypersensitivity to Degludec
  • Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.

Other

  • Use of an insulin pump
  • Use of a short-acting insulin
  • Participation or has participated in another trial within 90 days of the screening visit
  • Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method
  • Known skin reactions to CGM adhesives

Who the study is looking for

  • Age 18 years or older at signing of informed consent
  • Diagnosis of Type 2 Diabetes minimum 180 days before the day of screening
  • Hemoglobin A1c between 7-9% and measured by local lab at screening
  • On daily basal insulin for at least 90 days before inclusion into the study
  • Stable dose of oral and injectable (other than insulin) antidiabetic medications for 90 days prior inclusion. Acceptable medications include:
    • Metformin
    • Sulfonylureas
    • Meglitinides (glinides)
    • Dipeptidyl peptidase 4 (DPP-4) inhibitors
    • Sodium glucose co-transporter 2 (SGLT2) inhibitors
    • Thiazolidinediones
    • Alpha-glucosidase inhibitors
    • Oral combination products (for the allowed individual oral anti-diabetic drugs)
    • Oral or injectable Glucagon-like peptide-1 (GLP-1) Receptor Agonists (RAs)
    • If on sulfonylureas or glinides, willingness to reduce dose by 50%

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Virginia
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.