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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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In this 12-week prospective observational cohort study, hospitalized insulin-requiring patients with T2D will receive a Dexcom continuous glucose monitor (CGM) to wear post-hospital discharge. Patients will complete surveys assessing patient-reported outcomes prior to CGM use and following completion of the study. CGM data will be captured by the patient smartphone app and analyzed. Patients will receive personalized CGM targets and alerts for hyperglycemia and hypoglycemia. Customized reports/ decision support will be sent to the usual diabetes provider. The initial observational cohort study design will be followed by an extension phase of 12 weeks in which data on continuation of use and glucose control will be collected but no further reports will be communicated to providers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexcom CGM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DexCom G6 | Device | Wearable continuous glucose monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in TIR 70-180 mg/dl | Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks. | 12 weeks |
| % Wear Time >70% | The number of participants with % wear time >70% will be reported. | 12 weeks |
| DTSQc Score | The DTSQc compares the experience of the current treatment with the experience of the treatment before initiation of the study. Scores range from +3 ("much more satisfied now") to -3 ("much less satisfied now"), with 0 (midpoint) representing no change. Higher scores on the DTSQ total score indicate higher treatment satisfaction, and lower scores indicate lower treatment satisfaction. The total score ranges from -18 (maximum deterioration in satisfaction) to +18 (maximum improvement in satisfaction).A score of 0 indicates no change in satisfaction. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Dungan, MD | OSU Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center - Outpatient Care East | Columbus | Ohio | 43203 | United States |
• Availability of data and materials: In accordance with institution policy on sharing data and research resources, the final research data from this study may be made available for research purposes under a limited data use agreement specifying criteria for data access, conditions for research use, privacy and confidentiality standards to ensure data security and prohibitions for manipulating data for the purposes of identifying subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexcom CGM | DexCom G6: Wearable continuous glucose monitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexcom CGM | DexCom G6: Wearable continuous glucose monitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 TIR 70-180 mg/dl | Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks. | 54 participants had data at 2 weeks and 12 weeks | Posted | Mean | Standard Deviation | percentage of time spent 70-180 mg/dl | 12 weeks |
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12 weeks
Sensor adverse events include failure, bleeding, pain, infection and puritus
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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 | Dexcom CGM | DexCom G6: Wearable continuous glucose monitor | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensor event | Skin and subcutaneous tissue disorders | Systematic Assessment | Sensor related events including sensor failure, bleeding, pain, infection, or pruritus |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen Dungan | The Ohio State University | 6146853333 | kathleen.dungan@osumc.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 | Sep 21, 2023 | Nov 14, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline HbA1c | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
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| Primary | % Wear Time >70% | The number of participants with % wear time >70% will be reported. | 58 participants had CGM wear time at week 12 | Posted | Count of Participants | Participants | 12 weeks |
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| Primary | DTSQc Score | The DTSQc compares the experience of the current treatment with the experience of the treatment before initiation of the study. Scores range from +3 ("much more satisfied now") to -3 ("much less satisfied now"), with 0 (midpoint) representing no change. Higher scores on the DTSQ total score indicate higher treatment satisfaction, and lower scores indicate lower treatment satisfaction. The total score ranges from -18 (maximum deterioration in satisfaction) to +18 (maximum improvement in satisfaction).A score of 0 indicates no change in satisfaction. | 61 participants had an available DTSQ change score at 12 weeks | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
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| 108 |
| 0 |
| 108 |
| 30 |
| 108 |
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| D004700 | Endocrine System Diseases |