N/A
Completed N=56
Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes
Source: ClinicalTrials.gov NCT05523362 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Change in Average Glucose Levels as Measured by Continuous Glucose Monitor — 184; 148.6; 144.8; 147.2 mg/dl
Summary
The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Glucose Levels as Measured by Continuous Glucose Monitor |
184; 148.6; 144.8; 147.2 | — |
| PRIMARY Change in Time in Range as Measured by Continuous Glucose Monitor |
57.8; 82; 83.8; 82.5 | — |
| PRIMARY Change in Glucose Variability as Measured by Continuous Glucose Monitor |
26.2; 24.1; 24.1; 24 | — |
| SECONDARY Change in Hemoglobin A1c From Blood Test |
8.4; 6.9 | — |
| SECONDARY Change in Total Cholesterol From Blood Test |
162.6; 143.6 | — |
| SECONDARY Change in Low Density Lipoprotein Cholesterol From Blood Test |
82.8; 73.6 | — |
| SECONDARY Change in High Density Lipoprotein Cholesterol From Blood Test |
45.5; 43.9 | — |
| SECONDARY Change in Triglycerides From Blood Test |
173.3; 131.2 | — |
| SECONDARY Change in Body Mass Index From Height and Weight |
37.7; 34.9 | — |
| SECONDARY Change in Systolic Blood Pressure From Automated Cuff |
134.8; 126.0 | — |
| SECONDARY Change in Diastolic Blood Pressure From Automated Cuff |
79.4; 75.8 | — |
| SECONDARY Picture Your Plate Dietary Assessment Questionnaire |
61; 65.5 | — |
| SECONDARY Type 2 Diabetes Distress Screening Scale (T2-DDAS) |
2.4; 1.6 | — |
| SECONDARY International Physical Activity Questionnaire (IPAQ) |
2864.8; 3445.4 | — |
| SECONDARY Glucose Monitoring Satisfaction Survey |
— | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes of any duration
- Hb A1c ≥ 7% (no upper limit)
- BMI ≥ 30 kg/m2
- Ability to wear CGM (e.g. no dermatological issue precluding device insertion)
- Access to a smartphone device
Exclusion Criteria
- Any insulin use in the past 3 months
- Planned use of insulin in the next 6 months
- Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate
- Current use of a weight loss medication
- Unable or uncomfortable with wearing a CGM device
Data sourced from ClinicalTrials.gov (NCT05523362). 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.