N/A
Completed N=185
Dexcom G6 Intervention Study
Source: ClinicalTrials.gov NCT03877068 ↗Enrolled (actual)
185
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Mean Daily Blood Glucose (BG) Concentration While Hospitalized — 186.8; 183.2 mg/dL
Summary
The study will assess if Continuous Glucose Monitoring (CGM) represents a better tool to guide healthcare providers in adjusting insulin therapy, by providing a more complete 24-hour assessment of glucose values compared to Point of Care (POC) testing, during hospitalization and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D) and Type 1 Diabetes (T1D).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Blood Glucose (BG) Concentration While Hospitalized |
186.8; 183.2 | — |
| PRIMARY Percent of Time With BG Between 70-180 mg/dL While Hospitalized |
48.64; 54.51 | — |
| PRIMARY Number of Clinically Significant Hypoglycemia Events While Hospitalized |
0.56; 0.22 | — |
| SECONDARY Number of Hypoglycemia Events While Hospitalized |
1.15; 0.65 | — |
| SECONDARY Number of Nocturnal Hypoglycemia Events While Hospitalized |
0.34; 0.20; 0.23; 0.08 | — |
| SECONDARY Percent of Time With Hypoglycemia While Hospitalized |
2.15; 0.69; 1.00; 0.32 | — |
| SECONDARY Percent of Time With Hyperglycemia While Hospitalized |
49.21; 44.80; 17.08; 16.24 | — |
| SECONDARY Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized |
65.02; 61.24 | — |
| SECONDARY Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized |
13.717; 12.771; 16.414; 15.670 | — |
| SECONDARY Number of Sensor Changes During Hospitalization |
1; 13 | — |
| SECONDARY Mean Daily BG Concentration After Discharge |
200.41; 199.65 | — |
| SECONDARY Percent of Time With BG Between 70-180 mg/dL After Discharge |
43.42; 42.66 | — |
| SECONDARY Number of Clinically Significant Hypoglycemia Events After Discharge |
4.41; 2.30 | — |
| SECONDARY Number of Hypoglycemia Events After Discharge |
5.20; 3.77 | — |
| SECONDARY Count of Participants With Hypoglycemia After Discharge |
37; 42; 36; 38 | — |
| SECONDARY Percent of Time With Hyperglycemia After Discharge |
52.35; 54.96; 26.29; 23.03 | — |
| SECONDARY Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge |
58.55; 68.35 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females ≥ 18 years admitted to a general medicine or surgical services.
- History of T1D or T2D receiving insulin therapy during hospital admission.
- Subjects must have a randomization BG <400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 milliequivalents per litre (mEq/L), potential of hydrogen (pH) < 7.30, or positive serum or urinary ketones).
- Patients with expected hospital length-of-stay of 2 or more day
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.
- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).
- 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.
- Coronavirus Disease 2019 (COVID-19) infection
Data sourced from ClinicalTrials.gov (NCT03877068). 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.