Status:
COMPLETED
The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 w...
Detailed Description
This is an 18-week study designed to investigate the effect of a continuous glucose monitor (CGM) based titration algorithm versus a standard titration by self-monitoring blood glucose (SMBG) on glyce...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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%
- Exclusion Criteria
- Hypersensitivity to Degludec
- 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
- Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
- 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
- Known skin reactions to CGM adhesives
- 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
Exclusion
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06111508
Start Date
November 29 2023
End Date
September 16 2024
Last Update
October 8 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
2
University of Virginia
Charlottesville, Virginia, United States, 22903