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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04800471
Enrollment
30
Registered
2021-03-16
Start date
2021-08-16
Completion date
2024-07-09
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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)

Detailed description

Diabetes is affecting millions of Americans. High glucose levels lead to complications such as heart attacks, stroke or blindness. Patients with diabetes need to exercise at least 150 min/week, a goal however that is not usually achieved. Reducing high glucose levels may unfortunately lead to very low glucose values-hypoglycemia, a condition that can lead to loss of consciousness or even death. Both of these conditions, high and low glucose levels, can therefore lead to visits to the Emergency department or hospitalizations. In fact, patients with diabetes have frequent admissions to the hospital. Additionally, many of them are admitted again, immediately or in less than 30 days after hospital discharge. Most of patients with diabetes are monitoring their glucose values with finger-stick glucose testing. Continuous Glucose Monitors (CGMs) are new devices that can monitor glucose continuously (every couple of minutes) without the need of finger-stick glucose testing. Similar to the glucometers, CGM devices can record glucose values, which can then be obtained by the clinicians, who can help them to modify DM medications. In addition to using CGM devices for diabetes management, smart insulin pens can be used in order to help with diabetes control. These devices can store and transfer data to the medical doctors, making them aware about the patients' glucose values. Moreover there are different health solutions available to manage patients including mobile health and telemedicine, which can help combining and transferring these data remotely. Briefly, telemedicine is a way to deliver healthcare where providers and patients communicate through alternative methods (telephone or other electronic method for example) instead of only traditional in-person office visits. Using telemedicine to replace some routine office visits can improve access to healthcare. It can also improve communication between patients and providers which is often a challenge to diabetes management. You may be able to more quickly and safely change medications to help the patients' diabetes control. In this application we are going to examine whether utilizing telemedicine is a better communication tool between patients and providers and if it will lead to improved blood sugar control and increased exercise pattern compared to traditional monitoring with glucometers and in-person office visits only. We believe that this intervention may lead to better clinical outcomes.

Interventions

DEVICESmart insulin pens and CGM

Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices

OTHERPoint of Care Glucose Group

Participants in this group will be monitored by POC glucose values.

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Hyperglycemia (Percent Change in HbA1c)3 monthsHbA1C test is a blood test that shows your average level of blood glucose, also called blood sugar, over the past three months.

Secondary

MeasureTime frameDescription
Change in Hyperglycemia (Percent Change in HbA1c)6 monthsThe change in Hb1Ac (baseline to 6 months) is reported in percent
Change in Hypoglycemia6 monthsChange in hypoglycemic episodes (CGM glucose \<70 mg/dl for at least 15 min)
Change in Clinically Significant Hypoglycemia3 monthsChange in clinically significant hypoglycemic episodes (CGM\<54 mg/dl at least 15 min)
Change in Percentage of Glucose Values in Range (70-180 mg/dl)up to 3 monthsWe report the change of percentage of CGM glucose values in the range (70-180 mg/dl)
Change in Percentage of Glucose Values Below Range (<70 mg/dl)3 monthsWe report the change of percentage of CGM glucose values below the range (\<70 mg/dl)
Change in Percentage of Glucose Values Above Range (>180 mg/dl)3 monthsWe report the change of percentage of CGM glucose values Above Range (\>180 mg/dl)
Change in Glucose Variability3 monthsChange in Coefficient of Variation (CV)

Countries

United States

Baseline characteristics

Characteristic
Age, Continuous64.50 years
STANDARD_DEVIATION 7.86
HbA1c9.37 percentage of HbA1c
STANDARD_DEVIATION 1.18
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
16 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
8 Participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 13
other
Total, other adverse events
0 / 110 / 13
serious
Total, serious adverse events
0 / 110 / 13

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026