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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smart insulin pens and CGM | Active Comparator | Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices |
|
| Point of Care Glucose Group | Placebo Comparator | Participants in this group will be monitored by point of care glucose values |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart insulin pens and CGM | Device | Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hyperglycemia (Percent Change in HbA1c) | The change in Hb1Ac (baseline to 6 months) is reported in percent | 6 months |
| Change in Hypoglycemia | Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min) |
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Inclusion Criteria:
Insulin-treated patients with DM2 (treated with basal-bolus insulin regimens (MDI), ± non-insulin medications) and Uncontrolled glycemic control
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Point of Care Glucose Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The average age for each group |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | HbA1c percent change | 3 months |
|
From enrollment to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ilias Spanakis | Baltimore VA Medical Center | 410 605 7000 | 57394 | ispanakis@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2021 | Feb 6, 2026 | Prot_SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2023 | Feb 6, 2026 | ICF_006.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Point of Care Glucose Group | Other | Participants in this group will be monitored by POC glucose values. |
|
| 6 months |
| Change in Hypoglycemia | Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min) | 3 months |
| Change in Clinically Significant Hypoglycemia | Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min) | 3 months |
| Change in Clinically Significant Hypoglycemia | Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min) | 6 months |
| Change in Percentage of Glucose Values in Range (70-180 mg/dl) | We report the change of percentage of CGM glucose values in the range (70-180 mg/dl) | up to 3 months |
| Change in Percentage of Glucose Values in Range (70-180 mg/dl) | We report the change of percentage of CGM glucose values in the range (70-180 mg/dl) | up to 6 months |
| Change in Percentage of Glucose Values Below Range (<70 mg/dl) | We report the change of percentage of CGM glucose values below the range (<70 mg/dl) | 3 months |
| Change in Percentage of Glucose Values Below Range (<70 mg/dl) | We report the change of percentage of CGM glucose values below the range (<70 mg/dl) | 6 months |
| Change in Percentage of Glucose Values Above Range (>180 mg/dl) | We report the change of percentage of CGM glucose values Above Range (>180 mg/dl) | 3 months |
| Change in Percentage of Glucose Values Above Range (>180 mg/dl) | We report the change of percentage of CGM glucose values Above Range (>180 mg/dl) | 6 months |
| Change in Glucose Variability | Change in Coefficient of Variation (CV) | 3 months |
| Change in Glucose Variability | Change in Coefficient of Variation (CV) | 6 months |
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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Total males and females in each group | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race counts in each group | Count of Participants | Participants |
|
| HbA1c | Average Baseline HbA1c per group | Mean | Standard Deviation | percentage of HbA1c |
|
|
|
| Secondary | Change in Hyperglycemia (Percent Change in HbA1c) | The change in Hb1Ac (baseline to 6 months) is reported in percent | Posted | Mean | 95% Confidence Interval | HbA1c percent change | 6 months |
|
|
|
| Secondary | Change in Hypoglycemia | Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min) | Posted | Mean | 95% Confidence Interval | Hypoglycemic events <70 mg/dL | 6 months |
|
|
|
| Secondary | Change in Hypoglycemia | Change in hypoglycemic episodes (CGM glucose <70 mg/dl for at least 15 min) | Posted | Mean | 95% Confidence Interval | Hypoglycemia events < 70 mg/dL | 3 months |
|
|
|
| Secondary | Change in Clinically Significant Hypoglycemia | Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min) | Posted | Mean | 95% Confidence Interval | Hypoglycemic events <54mg/dL | 3 months |
|
|
|
| Secondary | Change in Clinically Significant Hypoglycemia | Change in clinically significant hypoglycemic episodes (CGM<54 mg/dl at least 15 min) | Posted | Mean | 95% Confidence Interval | Hypoglycemic events <54mg/dL | 6 months |
|
|
|
| Secondary | Change in Percentage of Glucose Values in Range (70-180 mg/dl) | We report the change of percentage of CGM glucose values in the range (70-180 mg/dl) | Posted | Mean | 95% Confidence Interval | Change in Percentage of glucose values | up to 3 months |
|
|
|
| Secondary | Change in Percentage of Glucose Values in Range (70-180 mg/dl) | We report the change of percentage of CGM glucose values in the range (70-180 mg/dl) | Posted | Mean | 95% Confidence Interval | Change in Percentage of glucose values | up to 6 months |
|
|
|
| Secondary | Change in Percentage of Glucose Values Below Range (<70 mg/dl) | We report the change of percentage of CGM glucose values below the range (<70 mg/dl) | Posted | Mean | 95% Confidence Interval | Change in Percentage of glucose values | 3 months |
|
|
|
| Secondary | Change in Percentage of Glucose Values Below Range (<70 mg/dl) | We report the change of percentage of CGM glucose values below the range (<70 mg/dl) | Posted | Mean | 95% Confidence Interval | Change in Percentage of glucose values | 6 months |
|
|
|
| Secondary | Change in Percentage of Glucose Values Above Range (>180 mg/dl) | We report the change of percentage of CGM glucose values Above Range (>180 mg/dl) | Posted | Mean | 95% Confidence Interval | Change in Percentage of glucose values | 3 months |
|
|
|
| Secondary | Change in Percentage of Glucose Values Above Range (>180 mg/dl) | We report the change of percentage of CGM glucose values Above Range (>180 mg/dl) | Posted | Mean | 95% Confidence Interval | Change in Percentage of glucose values | 6 months |
|
|
|
| Secondary | Change in Glucose Variability | Change in Coefficient of Variation (CV) | Posted | Mean | 95% Confidence Interval | percentage of coefficient of variation | 3 months |
|
|
|
| Secondary | Change in Glucose Variability | Change in Coefficient of Variation (CV) | Posted | Mean | 95% Confidence Interval | percentage of coefficient of variation | 6 months |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |