N/A
N=30
Improving Glycemic Control in DM2 Patients in the Ambulatory Setting
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT04800471 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Change in Hyperglycemia (Percent Change in HbA1c) — -2.2; -1.0 HbA1c percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Smart insulin pens and CGM (Device); Point of Care Glucose Group (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hyperglycemia (Percent Change in HbA1c) |
-2.2; -1.1 | — |
| SECONDARY Change in Hyperglycemia (Percent Change in HbA1c) |
-2.2; -1.1 | — |
| SECONDARY Change in Hypoglycemia |
0.5; -0.1 | — |
| SECONDARY Change in Hypoglycemia |
0.5; -0.1 | — |
| SECONDARY Change in Clinically Significant Hypoglycemia |
0.1; -0.5 | — |
| SECONDARY Change in Clinically Significant Hypoglycemia |
0.1; -0.5 | — |
| SECONDARY Change in Percentage of Glucose Values in Range (70-180 mg/dl) |
15.4; 17.3 | — |
| SECONDARY Change in Percentage of Glucose Values in Range (70-180 mg/dl) |
15.4; 17.3 | — |
| SECONDARY Change in Percentage of Glucose Values Below Range (<70 mg/dl) |
0.4; -0.9 | — |
| SECONDARY Change in Percentage of Glucose Values Below Range (<70 mg/dl) |
0.4; -0.9 | — |
| SECONDARY Change in Percentage of Glucose Values Above Range (>180 mg/dl) |
-20.4; -17.9 | — |
| SECONDARY Change in Percentage of Glucose Values Above Range (>180 mg/dl) |
-20.4; -17.9 | — |
| SECONDARY Change in Glucose Variability |
-2.0; -3.0 | — |
| SECONDARY Change in Glucose Variability |
-2.0; -3.0 | — |
Summary
More than 10.5% of the US population has diabetes mellitus. The objective of this pilot study is to evaluate whether smart insulin pens combined with CGM devices can improve glucose control in patients with type 2 diabetes (T2D)
Eligibility Criteria
Inclusion Criteria
Insulin-treated patients with DM2 (treated with basal-bolus insulin regimens (MDI), ± non-insulin medications) and Uncontrolled glycemic control
Exclusion Criteria
- History of type 1 DM (DM1)
- Pregnant Patients
- Extensive skin changes/disease or allergies that preclude wearing the CGM sensor
- Subjects who have end-stage renal disease requiring dialysis
- Significant psychiatric illness or any other condition rendering the subject incapable of understanding the objectives and potential consequences of the study
Data sourced from ClinicalTrials.gov (NCT04800471). 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.