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

Launched by UNIVERSITY OF VIRGINIA · Oct 26, 2023

Keywords

ClinConnect Summary

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 glycemic control in Type 2 Diabetes (T2DM) participants using insulin Degludec. After 2 weeks of blinded CGM baseline observation, participants are randomized 2:1 to CGM-based titration or standard titration by SMBG for 16 weeks. In the SMBG group, all titrated doses will be reviewed by a study physician prior to use and participants will wear a blinded CGM during the whole study. After completion o...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older at signing of informed consent
• • 2. Diagnosis of Type 2 Diabetes minimum 180 days before the day of screening
• • 3. Hemoglobin A1c between 7-9% and measured by local lab at screening
• • 4. On daily basal insulin for at least 90 days before inclusion into the study
• 5. Stable dose of oral and injectable (other than insulin) antidiabetic medications for 90 days prior inclusion. Acceptable medications include:
• • 1. Metformin
• • 2. Sulfonylureas
• • 3. Meglitinides (glinides)
• • 4. Dipeptidyl peptidase 4 (DPP-4) inhibitors
• • 5. Sodium glucose co-transporter 2 (SGLT2) inhibitors
• • 6. Thiazolidinediones
• • 7. Alpha-glucosidase inhibitors
• • 8. Oral combination products (for the allowed individual oral anti-diabetic drugs)
• • 9. Oral or injectable Glucagon-like peptide-1 (GLP-1) Receptor Agonists (RAs)
• • 10. If on sulfonylureas or glinides, willingness to reduce dose by 50%
• • Exclusion Criteria
• • 1. Hypersensitivity to Degludec
• • 2. Use of an insulin pump
• • 3. Use of a short-acting insulin
• • 4. Participation or has participated in another trial within 90 days of the screening visit
• • 5. Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method
• • 6. Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
• • 7. 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
• • 8. Known skin reactions to CGM adhesives
• • 9. Current/prior use of CGM within 30 days of the screening visit
• • 10. Any planned surgery or procedures where basal insulin would be decreased or held in anticipation