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 3.9-10.0 mmol/L (70-180 mg/dL)
Change in CGM-measured time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TIR = TIR (weeks 14-16) - TIR (baseline). Change in TIR is measured with percentage points as TIR is measured with the percentage time spent within the range 3.9-10.0 mmol/L (70-180 mg/dL).
Time frame: From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)
Change in HbA1c
Percent change in HbA1c measured as percentage
Time frame: From week 0 to week 16
Change in Time in Tight Range 3.9-7.8 mmol/L (70-140 mg/dL)
Percent change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TITR = TITR (weeks 14-16) - TITR (baseline).
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) from baseline to weeks 14-16, compared between control and experimental arm. change in TAR = TAR (weeks 14-16) - TAR (baseline).
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 (TAR2) 13.9 mmol/L (250 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TAR2 = TAR2 (weeks 14-16) - TAR2 (baseline).
Time frame: From baseline (week -2-0) to week 14-16
Change in Mean Glucose Level
The average CGM-measured blood glucose level (mg/dL).
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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 Time Below 3.9 mmol/L (70 mg/dL)
Percent of time spent below (TBR) 3.9 mmol/L (70 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TBR = TBR (weeks 14-16) - TBR (baseline).
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 (TBR2) 3.0 mmol/L (54 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TBR2 = TBR2 (weeks 14-16) - TBR2 (baseline).
Time frame: From baseline (week -2-0) to week 14-16
Basal Insulin Dose Changes
The investigator changes the dose from baseline to week 16
Time frame: From week 0 to week 16
Percent Acceptance Rate
Investigator acceptance rate of weekly dose guidance from Experimental arm only. Measure is calculated for each participant as 100x(number of accepted doses)/(number of recommended doses). Median and IQR is reported.
Time frame: From week 0 to week 16