N/A
Completed N=101
Dexcom G6 Observational Study
Source: ClinicalTrials.gov NCT03832907 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Mean Daily Blood Glucose by POC Reading сompared to CGM Reading — 175.55; 175.84 mg/dL
Summary
This is an exploratory prospective study primary aiming to evaluate differences between Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2) identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2 diabetes treated with basal bolus insulin regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Blood Glucose by POC Reading сompared to CGM Reading |
175.55; 175.84 | — |
| PRIMARY Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading |
9; 29 | — |
| PRIMARY Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading |
305; 518 | — |
| SECONDARY Mean Daily Blood Glucose by POC Reading Compared to CGM Reading |
175.55; 173.13 | — |
| SECONDARY Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading |
9; 29 | — |
| SECONDARY Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading |
305; 399 | — |
| SECONDARY Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading |
1; 22; 9 | — |
| SECONDARY Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading |
36; 144; 115 | — |
| SECONDARY Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading |
10; 100; 48 | — |
| SECONDARY Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading |
118.70; 89.14 | — |
| SECONDARY Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading |
4624.3; 1706.1 | — |
| SECONDARY Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading |
153; 554; 316 | — |
| SECONDARY Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading |
59.56; 52.62; 51.60 | — |
| SECONDARY Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading |
10; 4.6 | — |
| SECONDARY Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading |
5.3; 2.9 | — |
| SECONDARY Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading |
91; 89 | — |
| SECONDARY Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading |
89; 94 | — |
| SECONDARY Glycemic Variability Calculated by Standard Deviation by CGM Reading |
46.37; 43.87 | — |
| SECONDARY Glycemic Variability Calculated by MAGE by CGM Reading |
58.73; 56.68 | — |
| SECONDARY Number of Sensor Removal/Failures/Dislodgments |
31 | — |
| SECONDARY Mean Absolute Relative Difference (MARD) of CGM Compared to POC |
12.54; 12.22 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG |
89.3; 85.2 | — |
| SECONDARY Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen |
82.4; 16.5; 0.1; 1 | — |
| SECONDARY Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm |
81.4; 17.6; 0.1; 0.9 | — |
| SECONDARY Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading |
0; 8; 3 | — |
| SECONDARY Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading |
9; 60; 29 | — |
| SECONDARY Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading |
3; 48; 16 | — |
| SECONDARY Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading |
3.4; 0 | — |
| SECONDARY Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading |
53; 43 | — |
| SECONDARY Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading |
1.8; 2.9 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG |
93.1; 92.9 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG |
93.3; 94.9 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG |
95.5; 94 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG |
78.6; 74.1 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG |
82.0; 82.0 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG |
84.7; 81.1 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG |
83.2; 83.6 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG |
75.0; 66.7 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG |
69.4; 70.5 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG |
69.6; 73.8 | — |
| SECONDARY Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG |
71.0; 71.5 | — |
Eligibility Criteria
Inclusion Criteria
- > 18 years admitted to a general medicine or surgical service.
- Known history of T1D or T2D receiving insulin therapy
- Subjects must have a randomization BG between 140 mg and 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).
- Patients with expected hospital length-of-stay of 3 or more days
Exclusion Criteria
- Patients with acute illness admitted to the ICU or expected to require admission to the ICU.
- Patients expected to require MRI procedures during hospitalization.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
Data sourced from ClinicalTrials.gov (NCT03832907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.