CGM/Clarity Use, Glycemic Control and Clinical Outcomes
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/28/2019 |
| Start Date: | April 1, 2019 |
| End Date: | December 31, 2022 |
| Contact: | Ilias Spanakis, MD |
| Email: | ispanakis@medicine.umaryland.edu |
| Phone: | 4106057000 |
Improving Glycemic Control and Clinical Outcomes in Insulin Treated DM2 Patients Managed With CGM Devices and Clarity, a Randomized Clinical Trial
The prevalence of Diabetes Mellitus (DM) is rising and more than 30 million of Americans or
9.4% of the US population has DM. Several large scale randomized clinical trials have found
that improved glycemic control reduces the development of complications in patients with DM.
However intensive glucose management carries an increased risk of hypoglycemia, a condition
that may lead to neurological damage and is associated with increased incidence of
cardiovascular events and mortality.
Reducing uncontrolled hyperglycemia and hypoglycemia represents therefore an important
objective, as may decrease the direct and indirect impact that diabetes has in our health
care system. Achieving optimal glycemic control requires frequent blood glucose monitoring by
the patients and recurrent clinic visits,which is often difficult to achieve, as access to
typical DM clinic is at least sub optimal.
m-Health and telemedicine health solutions represent alternative ways to manage patients in
the outpatient setting and have been applied in different medical areas, among them in
diabetes. However, almost all the telemedicine studies that have been previously performed
and recruited DM patients used telemedicine solutions which were based on point of care (POC)
finger-stick glucose testing, which are checked infrequently , usually 4-6 times/day.
Continuous glucose monitoring (CGM) devices offer additional ways to monitor blood glucose
values and can provide numerous glucose measurements (as frequent as every 5 min). . By using
software applications, such as the Clarity (Dexcom), which highlights glucose patterns,
trends and statistics in standardized reports, providers can make safe recommendations of
adjusting DM medications, especially insulin titration. In this randomized clinical trial
investigators propose to use CGM devices and Clarity in high risk for hospitalization
individuals with DM2, in order to improve glycemic control and improve health outcomes.
9.4% of the US population has DM. Several large scale randomized clinical trials have found
that improved glycemic control reduces the development of complications in patients with DM.
However intensive glucose management carries an increased risk of hypoglycemia, a condition
that may lead to neurological damage and is associated with increased incidence of
cardiovascular events and mortality.
Reducing uncontrolled hyperglycemia and hypoglycemia represents therefore an important
objective, as may decrease the direct and indirect impact that diabetes has in our health
care system. Achieving optimal glycemic control requires frequent blood glucose monitoring by
the patients and recurrent clinic visits,which is often difficult to achieve, as access to
typical DM clinic is at least sub optimal.
m-Health and telemedicine health solutions represent alternative ways to manage patients in
the outpatient setting and have been applied in different medical areas, among them in
diabetes. However, almost all the telemedicine studies that have been previously performed
and recruited DM patients used telemedicine solutions which were based on point of care (POC)
finger-stick glucose testing, which are checked infrequently , usually 4-6 times/day.
Continuous glucose monitoring (CGM) devices offer additional ways to monitor blood glucose
values and can provide numerous glucose measurements (as frequent as every 5 min). . By using
software applications, such as the Clarity (Dexcom), which highlights glucose patterns,
trends and statistics in standardized reports, providers can make safe recommendations of
adjusting DM medications, especially insulin titration. In this randomized clinical trial
investigators propose to use CGM devices and Clarity in high risk for hospitalization
individuals with DM2, in order to improve glycemic control and improve health outcomes.
Inclusion Criteria:
- History of Diabetes Mellitus type 2 (DM2) on insulin
- Uncontrolled glycemic control [hyperglycemia defined as Hba1c≥9% in the last 3 months
or clinically important hypoglycemia (any reported glucose values less than 54 mg/dl)
or severe hypoglycemia (low glucose value that led to a severe event characterized by
altered mental status and or physical status requiring assistance)]
Exclusion Criteria:
- Subjects that have a history of type 1 DM
- History of type 2 DM, not treated or required to be treated with basal/bolus insulin
(i.e diet only, any combination of non insulin antidiabetic drugs only, basal only
insulin or bolus/short acting only insulin, or pre-mixed insulins) as these patients
are less likely to benefit from CGM use.
- Pregnant patients
- Use of Clarity/ Share or follow applications as telehealth/telemedicine to improve DM
management during the last 3 months prior to study entry.
- Extensive skin changes/disease or allergies that preclude wearing the CGM sensor
- Significant psychiatric illness or any mental condition rendering the subject
incapable of understanding the objectives and potential consequences of the study.
- Subjects without personal computer and internet network access.
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