The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: November 29, 2023
End Date: August 15, 2024
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
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Conditions:
- Diabetes Mellitus, Type 2