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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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The goal of this study is to assess the impact of physician-driven insulin setting changes in type 1 patients using multiple daily injection insulin therapy with exercise. This is a short outpatient study with multiple outpatient and home exercise sessions with an assigned type of exercise.
Subjects will be on study for 28 days. Sensor glucose, exercise, insulin and meal data will be collected during this time. Subjects will wear the Dexcom G6 CGM system and a physical activity monitor. The Subjects will complete 2 exercise visits in-clinic and 4 exercise visits as an outpatient. Subjects will be randomized to aerobic, anaerobic or high intensity interval exercise sessions for 30 minutes each. Physicians will review CGM and insulin data every 7 days and make insulin dose recommendations that the subject will adjust in the dose calculator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic exercise | Experimental | Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. |
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| Anaerobic exercise | Experimental | Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. |
|
| High intensity interval exercise | Experimental | Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 CGM | Device | Subjects will wear a Dexcom G6 CGM for the 28 days they are on study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time With Sensed Glucose 70-180 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity. The percent of time with sensed glucose 70-180 mg/dl was averaged across days 1-7. | Days 1-7 |
| Percent of Time With Sensed Glucose Less Than 70 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less than 70 mg/dl was averaged across days 1-7. | Days 1-7 |
| Percent of Time With Sensed Glucose 70-180 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose 70-180 mg/dl was averaged across days 22-28. | Days 22-28 |
| Percent of Time With Sensed Glucose Less Than 70 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 70 mg/dl was averaged across days 22-28. | Days 22-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Time With Sensed Glucose Less Than 54 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 1-7. | Days 1-7 |
| Mean Sensed Glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Castle, MD | Oregon Health and Science University | Principal Investigator |
| Peter Jacobs, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32694787 | Derived | Tyler NS, Mosquera-Lopez CM, Wilson LM, Dodier RH, Branigan DL, Gabo VB, Guillot FH, Hilts WW, El Youssef J, Castle JR, Jacobs PG. An artificial intelligence decision support system for the management of type 1 diabetes. Nat Metab. 2020 Jul;2(7):612-619. doi: 10.1038/s42255-020-0212-y. Epub 2020 Jun 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aerobic Exercise | Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study. |
| FG001 | Anaerobic Exercise | Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study. |
| FG002 | High Intensity Interval Exercise | Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Start up Visit (2 Hours) |
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| First at Home Period (9-14 Days) |
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| First Exercise Visit (1 Hour) |
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| Dexcom Insertion Visit (30 Minutes) |
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| Second at Home Period (2-11 Days) |
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| Second Exercise Visit (1 Hour) |
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| Third at Home Period (8-12 Days) |
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| Close-out Visit (30 Minutes) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aerobic Exercise | All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days. |
| BG001 | Anaerobic Exercise |
| 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 | Percent of Time With Sensed Glucose 70-180 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity. The percent of time with sensed glucose 70-180 mg/dl was averaged across days 1-7. | 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits. | Posted | Mean | Standard Deviation | percentage of time | Days 1-7 |
|
28 days
All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed the start up visit.
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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 | Aerobic Exercise | Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shoulder injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Work-related muscle injury |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Castle MD | Oregon Health and Science University | 503-494-7072 | castleje@ohsu.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 | Apr 18, 2019 | Feb 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Subjects randomly assigned to one of three types of exercise.
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Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 1-7. |
| Days 1-7 |
| Percent of Time With Sensed Glucose Less Than 54 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 22-28. | Days 22-28 |
| Mean Sensed Glucose | Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 22-28. | Days 22-28 |
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All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days.
| BG002 | High Intensity Interval Exercise | All study subjects were randomized to either aerobic, anaerobic or high intensity interval training. Subjects were on study for 28 days. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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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| Region of Enrollment | Number | participants |
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Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days.
| OG002 | High Intensity Interval Exercise | Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.Subjects are on study for 28 days. |
|
|
| Primary | Percent of Time With Sensed Glucose Less Than 70 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less than 70 mg/dl was averaged across days 1-7. | 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits. | Posted | Mean | Standard Deviation | percentage of time | Days 1-7 |
|
|
|
| Primary | Percent of Time With Sensed Glucose 70-180 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose 70-180 mg/dl was averaged across days 22-28. | 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits. | Posted | Mean | Standard Deviation | percentage of time | Days 22-28 |
|
|
|
| Primary | Percent of Time With Sensed Glucose Less Than 70 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 70 mg/dl was averaged across days 22-28. | 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits. | Posted | Mean | Standard Deviation | percentage of time | Days 22-28 |
|
|
|
| Secondary | Percent of Time With Sensed Glucose Less Than 54 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 1-7. | 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits. | Posted | Mean | Standard Deviation | percentage of time | Days 1-7 |
|
|
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| Secondary | Mean Sensed Glucose | Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 1-7. | 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits. | Posted | Mean | Standard Deviation | mg/dl | Days 1-7 |
|
|
|
| Secondary | Percent of Time With Sensed Glucose Less Than 54 mg/dl | Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 22-28. | 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits. | Posted | Mean | Standard Deviation | percentage of time | Days 22-28 |
|
|
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| Secondary | Mean Sensed Glucose | Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 22-28. | 25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits. | Posted | Mean | Standard Deviation | mg/dl | Days 22-28 |
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| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Anaerobic Exercise | Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | High Intensity Interval Exercise | Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM. Dexcom G6 CGM: Subjects will wear a Dexcom G6 CGM for the 28 days they are on study. | 0 | 9 | 0 | 9 | 3 | 9 |
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| redness and swelling at sensor site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| upper respiratory infection | Infections and infestations | Non-systematic Assessment |
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| lightheadedness | Vascular disorders | Non-systematic Assessment |
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OHSU shall submit for Dexcom's review and comment all publications which result from this Trial. Written copies of results shall be submitted to the Dexcom no later than 45 days before publication and Dexcom shall provide its comments within 30 days, which OHSU will incorporate and honor.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |