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.

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).

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 of the 16-week titration, participants are followed up for 2 days. Participants will be divided related to use of sulfonylureas or glinides with a maximum cap of nine participants being treated with sulfonylureas and glinides to complete the study.

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