Improving Glycemic Control in DM2 Patients in the Ambulatory Setting
Improving Glycemic Control and Clinical Outcomes in DM2 Patients in the Ambulatory Setting, a Pilot Study
1 other identifier
interventional
30
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Aug 2021
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
August 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2024
CompletedResults Posted
Study results publicly available
February 10, 2026
CompletedFebruary 10, 2026
January 1, 2026
2.9 years
March 11, 2021
October 20, 2025
February 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Hyperglycemia (Percent Change in HbA1c)
HbA1C test is a blood test that shows your average level of blood glucose, also called blood sugar, over the past three months.
3 months
Secondary Outcomes (13)
Change in Hyperglycemia (Percent Change in HbA1c)
6 months
Change in Hypoglycemia
6 months
Change in Hypoglycemia
3 months
Change in Clinically Significant Hypoglycemia
3 months
Change in Clinically Significant Hypoglycemia
6 months
- +8 more secondary outcomes
Study Arms (2)
Smart insulin pens and CGM
ACTIVE COMPARATORParticipants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices
Point of Care Glucose Group
PLACEBO COMPARATORParticipants in this group will be monitored by point of care glucose values
Interventions
Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices
Participants in this group will be monitored by POC glucose values.
Eligibility Criteria
You may qualify if:
- Insulin-treated patients with DM2 (treated with basal-bolus insulin regimens (MDI), ± non-insulin medications) and Uncontrolled glycemic control
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ilias Spanakis
- Organization
- Baltimore VA Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
March 11, 2021
First Posted
March 16, 2021
Study Start
August 16, 2021
Primary Completion
July 9, 2024
Study Completion
July 9, 2024
Last Updated
February 10, 2026
Results First Posted
February 10, 2026
Record last verified: 2026-01