The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Particip… (NCT06111508) | Clinical Trial Compass
CompletedNot Applicable
The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.
United States30 participantsStarted 2023-11-29
Plain-language 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 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).
Who can participate
Age range18 Years
SexALL
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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)
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.
What they're measuring
1
Change in Time in Range 3.9-10.0 mmol/L (70-180 mg/dL)
Timeframe: From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)
✕. 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