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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DK051562-19A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study is evaluate the superior efficacy of a Continuous Glucose Monitor (CGM)-based advisory system in Type 1 Diabetes Mellitus (T1DM), as compared to Sensor Augmented Mode (SAM) therapy, and with characterizing the impact of psycho-behavioral factors on system performance, which will enable system individualization and lead to automated adaptation of advice delivery to optimize glycemic control and reduce the system's psychological impact.
Four cohorts of about 25 participants each (expected retention 20 per cohort). Each cohort will continue for ~7 months. Following recruitment, screening, and a run-in period of SAM, participants will be randomized into one of two groups: escalation vs. de-escalation of devices and function. Each treatment modality (SAM - Sensor-Augmented Mode, PF - Personalized Feedback, DSS - Decision Support Systems) will continue for about 8 weeks, with the last 4 weeks used to assess glucose variability (GV) from CGM data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De-escalation | Experimental | Subjects randomized to this arm will proceed from DSS to PF to SAM |
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| Escalation | Experimental | Subjects randomized to this arm will proceed from SAM to PF to DSS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Feedback | Device | Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Outcomes | Glucose Variability (GV) as measured by CGM-based Coefficient of Variation (CV), as recommended by the International Consensus on Use of Continuous Glucose Monitoring. | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time in Clinical Hypoglycemia | Percentage of time blood glucose was below 54mg/dL as per CGM | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
| Percent Time Below Recommended Threshold |
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Inclusion Criteria:
Exclusion Criteria:
NPH (neutral protamine hagedorn) insulin
Use of any medication that at the discretion of the investigator is deemed to interfere with the trial.
Current treatment of a primary seizure disorder
Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
Hemophilia or any other bleeding disorder
A known medical condition, which in the opinion of the investigator or designee, would put the participant or study at risk such as the following examples:
A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
Not familiar with smart phone technology
Current use of the following drugs and supplements:
Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
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| Name | Affiliation | Role |
|---|---|---|
| Marc Breton, PhD | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
Pending
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Once eligibility and device training was completed, participants completed a minimum of 14 days (if CGM use within the preceding 3 months) or 4 weeks (if no CGM use within the preceding 3 months) of home use of the DiAs system in Sensor-Augmented Mode (SAM). One participant elected to withdraw from the study.
Study enrollment began September 4, 2020, and all study activities were completed on September 19, 2024. As defined in the protocol, a participant is considered enrolled when the informed consent form has been signed by the participant and the study team. Eighty-eight (88) signed consent, and 26 participants screen failed, withdrew, or dropped prior to screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Escalation | Subjects randomized to this arm will proceed from SAM to PF to DSS Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user. Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes. |
| FG001 | De-escalation | Subjects randomized to this arm will proceed from DSS to PF to SAM Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user. Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First intervention (8 weeks) |
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| Second intervention (8 weeks) |
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| Third Intervention (8 weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Escalation | Subjects randomized to this arm will proceed from SAM to PF to DSS Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user. Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Glycemic Outcomes | Glucose Variability (GV) as measured by CGM-based Coefficient of Variation (CV), as recommended by the International Consensus on Use of Continuous Glucose Monitoring. | Posted | Mean | Standard Deviation | Percent of coefficient of variation | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
|
7 months
Adverse Event definitions are the same as ClinicalTrials.Gov. Please see protocol for further details about adverse event reporting.
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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 | Sensor-augmented mode (SAM) | Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hypoglycemia | Endocrine disorders | Systematic Assessment | High BGs night before event. BG=340 @645 AM-took Humalog 3u & Lantus 6u @730 AM. BG=68 at 8 AM-Took 100g carbs. BG=280 @10 AM-took Humalog 2u. Very active in AM. Seizure ~1130 AM. CGM=66 @1135 AM. EMS glucose tx. Fully recovered/no hospitalization. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Breton, PhD | UVA Center for Diabetes Technology | 434-982-6484 | marc.breton@virginia.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 | Oct 5, 2021 | Oct 1, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 1, 2022 | Jun 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Decision Support System | Device | CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges |
|
| Sensor Augmented Mode | Device | A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes. |
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Percentage of time blood glucose was below 70mg/dL as per CGM
| Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
| Percent Time in Target Range | Percentage of time blood glucose was 70mg/dL and 180mg/dL as per CGM | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
| Percent Time Above Range | Percentage of time blood glucose was above 180mg/dL as per CGM | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
| Percent Time Above 250 mg/dL | Percentage of time blood glucose was above 250mg/dL as per CGM | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
| Average Glycemia | average of CGM values | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
| Low Blood Glucose Index | The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values <1 suggest low risk of hypoglycemia. | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
| High Blood Glucose Index | The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk. | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
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| NOT COMPLETED |
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| BG001 | De-escalation | Subjects randomized to this arm will proceed from DSS to PF to SAM Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user. Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Highest education level | Count of Participants | Participants |
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| Last year household income | Count of Participants | Participants |
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| Health Insurance | Count of Participants | Participants |
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| Number of participants with each infusion set type | Count of Participants | Participants |
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| OG001 | De-escalation | Subjects randomized to this arm will proceed from DSS to PF to SAM Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user. Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges Sensor Augmented Mode: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes. |
|
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| Secondary | Percent Time in Clinical Hypoglycemia | Percentage of time blood glucose was below 54mg/dL as per CGM | Posted | Mean | Standard Deviation | Percent of time | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
|
|
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| Secondary | Percent Time Below Recommended Threshold | Percentage of time blood glucose was below 70mg/dL as per CGM | Posted | Mean | Standard Deviation | Percentage of time | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
|
|
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| Secondary | Percent Time in Target Range | Percentage of time blood glucose was 70mg/dL and 180mg/dL as per CGM | Posted | Mean | Standard Deviation | Percentage of time | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
|
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| Secondary | Percent Time Above Range | Percentage of time blood glucose was above 180mg/dL as per CGM | Posted | Mean | Standard Deviation | Percent of time | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
|
|
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| Secondary | Percent Time Above 250 mg/dL | Percentage of time blood glucose was above 250mg/dL as per CGM | Posted | Mean | Standard Deviation | Percentage of time | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
|
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| Secondary | Average Glycemia | average of CGM values | Posted | Mean | Standard Deviation | mg/dl | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
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| Secondary | Low Blood Glucose Index | The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values <1 suggest low risk of hypoglycemia. | Posted | Mean | Standard Deviation | index | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
|
|
|
| Secondary | High Blood Glucose Index | The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk. | Posted | Mean | Standard Deviation | index | Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention |
|
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|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Personalized Feedback (PF) | Personalized Feedback: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user. | 0 | 53 | 1 | 53 | 0 | 53 |
| EG002 | Decision support system (DSS) | Decision Support System: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges | 0 | 53 | 1 | 53 | 0 | 53 |
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| Severe Hypoglycemia | Endocrine disorders | Systematic Assessment | Woke by alarm @4:45 AM. CGM=100mg/dL trending down; intent to sleep 15 min. Wellness check at 830AM when he didn't respond to spouse's call-drank juice provided by friend. CGM=42mg/dL @850AM. At 9:00 AM, participant reports feeling better. |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| DSS |
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| DSS |
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| DSS |
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| DSS |
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| DSS |
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| DSS |
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| DSS |
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| DSS |
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