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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A Continuous Glucose Monitoring (CGM)-based once weekly titration algorithm of basal insulin as implemented in DiAs Cloud platform
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Virginia
Charlottesville, Virginia, United States
Change in Time in Range
Change in CGM-measured time in range 3.9-10.0 mmol/L (70-180 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm.
Time frame: From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)
Change in HbA1c
Percent change in HbA1c
Time frame: From week 0 to week 16
Change in Time in Tight Range
Percent change in time in tight range 3.9-7.8 mmol/L (70-140 mg/dL)
Time frame: From baseline (week -2-0) to week 14-16
Change in Time above 10.0 mmol/L (180 mg/dL)
Percent of time spent above 10.0 mmol/L (180 mg/dL).
Time frame: From baseline (week -2-0) to week 14-16
Change in Time above 13.9 mmol/L (250 mg/dL)
Percent of time spent above 13.9 mmol/L (250 mg/dL)
Time frame: From baseline (week -2-0) to week 14-16
Change in Continuous Glucose Monitoring Coefficient of variation (%)
The statistical measure (%) of the relative dispersion of data points in a data series around the average CGM-measured blood glucose level.
Time frame: From baseline (week -2-0) to week 14-16
Change in Mean Glucose Level
The average CGM-measured blood glucose level (mmol/L).
Time frame: From baseline (week -2-0) to week 14-16
Change in Time below 3.9 mmol/L (70 mg/dL)
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Percent of time spent below 3.9 mmol/L (70 mg/dL).
Time frame: From baseline (week -2-0) to week 14-16
Change in Time below 3.0 mmol/L (54 mg/dL)
Percent of time spent below 3.0 mmol/L (54 mg/dL).
Time frame: From baseline (week -2-0) to week 14-16
Frequency of Hypoglycemic Events
The number of clinically significant hypoglycemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycemic episodes (level 3).
Time frame: From week 0 to week 16
Frequency of Serious Adverse Events
The number of serious adverse events (SAEs).
Time frame: From week 0 to week 16
Frequency of Treatment Emergent Adverse Events
The number of treatment emergent adverse events (TAEs).
Time frame: From week 0 to week 16
Frequency of Device Deficiencies
The number of device deficiencies (DDs). A device malfunction is any failure of a device to meet its performance specifications or otherwise work as intended. Performance specifications include all claims made in the labelling for the device. The intended performance of a device refers to the intended use for which the device is labelled or marketed.
Time frame: From week 0 to week 16
Percent Acceptance Rate
Investigator acceptance rate of weekly dose guidance - from CGM-based titration (Experimental arm only).
Time frame: From week 0 to week 16
Frequency of Dose Changes
The investigator changes the dose from the recommended or the current dose (Experimental arm only).
Time frame: From week 0 to week 16