Trial Outcomes & Findings for Improving Glycemic Control in DM2 Patients in the Ambulatory Setting (NCT NCT04800471)

NCT ID: NCT04800471

Last Updated: 2026-02-10

Results Overview

HbA1C test is a blood test that shows your average level of blood glucose, also called blood sugar, over the past three months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2026-02-10

Participant Flow

Participant milestones

Measure	Smart Insulin Pens and CGM Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Overall Study STARTED	15	15
Overall Study COMPLETED	11	13
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Glycemic Control in DM2 Patients in the Ambulatory Setting

Baseline characteristics by cohort

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.	Total n=24 Participants Total of all reporting groups
Age, Continuous	65.00 years STANDARD_DEVIATION 7.05 • n=4 Participants	63.91 years STANDARD_DEVIATION 8.68 • n=4 Participants	64.50 years STANDARD_DEVIATION 7.86 • n=8 Participants
Sex: Female, Male Female	0 Participants n=4 Participants	2 Participants n=4 Participants	2 Participants n=8 Participants
Sex: Female, Male Male	11 Participants n=4 Participants	11 Participants n=4 Participants	22 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	8 Participants n=4 Participants	8 Participants n=4 Participants	16 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=4 Participants	5 Participants n=4 Participants	8 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
HbA1c	9.47 percentage of HbA1c STANDARD_DEVIATION 1.57 • n=4 Participants	9.37 percentage of HbA1c STANDARD_DEVIATION 1.18 • n=4 Participants	9.42 percentage of HbA1c STANDARD_DEVIATION 1.37 • n=8 Participants

PRIMARY outcome

Timeframe: 3 months

HbA1C test is a blood test that shows your average level of blood glucose, also called blood sugar, over the past three months.

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Hyperglycemia (Percent Change in HbA1c)	-2.2 HbA1c percent change 95% Confidence Interval (-3.1, -1.3) • Interval -3.1 to -1.3	-1.0 HbA1c percent change 95% Confidence Interval (1.9, -0.13 • Interval -1.9 to -0.13

SECONDARY outcome

Timeframe: 6 months

The change in Hb1Ac (baseline to 6 months) is reported in percent

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Hyperglycemia (Percent Change in HbA1c)	-2.2 HbA1c percent change Interval -3.2 to -1.3	-1.1 HbA1c percent change Interval -2.0 to -0.2

SECONDARY outcome

Timeframe: 6 months

Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Hypoglycemia	0.6 Hypoglycemic events <70 mg/dL Interval -2.2 to 1.0	-1.5 Hypoglycemic events <70 mg/dL Interval -3.0 to -0.1

SECONDARY outcome

Timeframe: 3 months

Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Hypoglycemia	0.5 Hypoglycemia events < 70 mg/dL Interval -1.1 to 2.1	-0.1 Hypoglycemia events < 70 mg/dL Interval -1.6 to 1.4

SECONDARY outcome

Timeframe: 3 months

Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Clinically Significant Hypoglycemia	0.1 Hypoglycemic events <54mg/dL Interval -0.8 to 0.9	0.0 Hypoglycemic events <54mg/dL Interval -0.8 to 0.8

SECONDARY outcome

Timeframe: 6 months

Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Clinically Significant Hypoglycemia	0.1 Hypoglycemic events <54mg/dL Interval -0.8 to 0.9	-0.5 Hypoglycemic events <54mg/dL Interval -1.3 to 0.2

SECONDARY outcome

Timeframe: up to 3 months

We report the change of percentage of CGM glucose values in the range (70-180 mg/dl)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Percentage of Glucose Values in Range (70-180 mg/dl)	13.4 Change in Percentage of glucose values Interval -8.6 to 35.5	13.7 Change in Percentage of glucose values Interval -6.6 to 34.0

SECONDARY outcome

Timeframe: up to 6 months

We report the change of percentage of CGM glucose values in the range (70-180 mg/dl)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Percentage of Glucose Values in Range (70-180 mg/dl)	15.4 Change in Percentage of glucose values Interval -6.7 to 37.4	17.3 Change in Percentage of glucose values Interval -3.0 to 17.5

SECONDARY outcome

Timeframe: 3 months

We report the change of percentage of CGM glucose values below the range (<70 mg/dl)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Percentage of Glucose Values Below Range (<70 mg/dl)	0.1 Change in Percentage of glucose values Interval -0.8 to 1.0	-0.2 Change in Percentage of glucose values Interval -1.1 to 0.6

SECONDARY outcome

Timeframe: 6 months

We report the change of percentage of CGM glucose values below the range (<70 mg/dl)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Percentage of Glucose Values Below Range (<70 mg/dl)	0.4 Change in Percentage of glucose values Interval -0.5 to 1.3	-0.9 Change in Percentage of glucose values Interval -1.7 to -0.1

SECONDARY outcome

Timeframe: 3 months

We report the change of percentage of CGM glucose values Above Range (>180 mg/dl)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Percentage of Glucose Values Above Range (>180 mg/dl)	-10.4 Change in Percentage of glucose values Interval -11.1 to -0.8	-16.2 Change in Percentage of glucose values Interval -35.1 to -2.6

SECONDARY outcome

Timeframe: 6 months

We report the change of percentage of CGM glucose values Above Range (>180 mg/dl)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Percentage of Glucose Values Above Range (>180 mg/dl)	-20.4 Change in Percentage of glucose values Interval -40.9 to 0.03	-17.9 Change in Percentage of glucose values Interval -36.7 to 0.9

SECONDARY outcome

Timeframe: 3 months

Change in Coefficient of Variation (CV)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Glucose Variability	1.9 percentage of coefficient of variation Interval -4.4 to 8.1	-1.7 percentage of coefficient of variation Interval -7.4 to 4.1

SECONDARY outcome

Timeframe: 6 months

Change in Coefficient of Variation (CV)

Outcome measures

Measure	Smart Insulin Pens and CGM n=11 Participants Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices Smart insulin pens and CGM: Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices	Point of Care Glucose Group n=13 Participants Participants in this group will be monitored by point of care glucose values Point of Care Glucose Group: Participants in this group will be monitored by POC glucose values.
Change in Glucose Variability	-2.0 percentage of coefficient of variation Interval -8.3 to 4.2	-3.0 percentage of coefficient of variation Interval -8.7 to 2.8

Adverse Events

Smart Insulin Pens and CGM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Point of Care Glucose Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ilias Spanakis

Baltimore VA Medical Center

Phone: 410 605 7000

Email: ispanakis@som.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place