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| Name | Class |
|---|---|
| Tandem Diabetes Care, Inc. | INDUSTRY |
| DexCom, Inc. | INDUSTRY |
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The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.
This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
Once deemed eligible, participants and their parent(s) will be trained on the use of the Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system. Participants will then use the this study equipment with their home insulin parameters at home for at home for 5 days. Participants will then come to the ski resort to participate in a 72-hour ski admission. Upon arrival, each participant will be randomized to either the using the Control-IQ system with their usual insulin parameters during the ski study and the at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and the at-home 5 days at home study. Study duration for each participant will require 5 study visits over about 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Closed Loop (HCL) | Active Comparator | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home. |
|
| Control-IQ with MyTDI | Experimental | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Closed Loop (HCL) | Device | Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Time in Range at Home Pre/Post Intervention at Home | The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days post camp (home) compared to 5 days before camp (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Average CGM at Home | Average of available CGM values within time frame | 5 days post camp (home) compared to 5 days before camp (baseline) |
| Average CGM at Camp | average of CGM values within time frame |
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Inclusion Criteria:
Criteria for documented hyperglycemia (at least 1 must be met):
Criteria for requiring insulin at diagnosis (both criteria must be met):
Age 12-18 years
Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart.
Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month.
Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study.
For females, not pregnant or breastfeeding. Female subjects who are sexually active should agree to use birth control during the study.
Total daily insulin dose (TDD) at least 10 U/day.
Exclusion Criteria:
Diabetic ketoacidosis in the past 6 months
Hypoglycemic seizure or loss of consciousness in the past 6 months
History of seizure disorder
History of any heart disease including coronary artery disease, heart failure, or arrhythmias
History of altitude sickness
Chronic pulmonary conditions that could impair oxygenation
Cystic fibrosis
Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgement of the investigator, would be a contraindication to participation in the study.
History of ongoing renal disease (other than microalbuminuria).
Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or Glargine).
Pregnancy
Presence of a febrile illness within 24 hours of the Ski Admission
Medical or psychiatric conditions that in the judgement of the investigator might interfere with the completion of the protocol such as:
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| Name | Affiliation | Role |
|---|---|---|
| Marc D. Breton, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32119790 | Background | Schoelwer MJ, Robic JL, Gautier T, Fabris C, Carr K, Clancy-Oliveri M, Brown SA, Anderson SM, DeBoer MD, Chernavvsky DR, Breton MD. Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2020 Aug;22(8):594-601. doi: 10.1089/dia.2019.0471. Epub 2020 Mar 2. |
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Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
Generally, data will be made available after the primary publications of each study.
Complete data sets will be provided to industry partners who would use the data for regulatory clearance (PMA - pre-market approval) of the tested artificial pancreas system. This will be done in response to the specific requirements of RFA-DK-14-024 for this project to "…generate data able to satisfy safety and efficacy requirements by regulatory agencies regarding the clinical testing of artificial pancreas device systems" in the target population of people with type 1 diabetes.
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1 participant dropped prior to randomization for personal reasons (travel issues); 1 participant dropped prior to randomization as they didn't attend screening appointment.
Of 22 enrolled participants, 20 were randomized to treatment. One participant was dropped after meeting stopping criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hybrid Closed Loop (HCL) | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home. Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity. |
| FG001 | Control-IQ With MyTDI | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hybrid Closed Loop (HCL) | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home. Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity. |
| 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 Time in Range at Home Pre/Post Intervention at Home | The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Mean | Standard Deviation | percentage of time spent in range | 5 days post camp (home) compared to 5 days before camp (baseline) |
|
13 days
Any untoward medical occurrence in a study participant, irrespective of the relationship between the adverse event and the device(s) under investigation
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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 | Hybrid Closed Loop (HCL) | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home. Hybrid Closed Loop (HCL): Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia or ketosis events without meeting criteria for Diabetes Ketoacidosis | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Breton, PhD | University of Virginia Center for Diabetes Technology | 434-982-6484 | mb6nt@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 | Feb 7, 2019 | Feb 15, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2019 | Feb 15, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) System t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
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|
| Control-IQ with MyTDI | Device | Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity. |
|
| 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
| Percentage of CGM Values Below 50mg/dL at Home | the percentage of CGM values falling below 50mg/dL, calculated as the number of CGM values <50mg/dL within the time frame divided by the total number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days post camp (home) compared to 5 days before camp (baseline) |
| Percentage of CGM Values Below 50mg/dL at Camp | the percentage of CGM values falling below 50mg/dL, computed as the number of CGM values <50mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) |
| Percentage of CGM Values Below 54mg/dL at Camp | the percentage of CGM values falling below 54mg/dL. computed as the number of CGM values <54mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
| Percentage of CGM Values Below 60mg/dL at Home | the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values <60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days post camp (home) compared to 5 days before camp (baseline) |
| Percentage of CGM Values Below 60mg/dL at Camp | the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values <60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) |
| Percentage of CGM Values Below 70mg/dL at Home | the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values <70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days post camp (home) compared to 5 days before camp (baseline) |
| Percentage of CGM Values Below 70mg/dL at Camp | the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values <70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) |
| Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp | the percentage of CGM values falling between 70mg/dL and 180mg/dL, computed as the number of CGM values <=180mg/dL and >70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
| Percentage of CGM Values Above 180mg/dL at Home | the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values >180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days post camp (home) compared to 5 days before camp (baseline) |
| Percentage of CGM Values Above 180mg/dL at Camp | the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values >180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
| Percentage of CGM Values Above 250mg/dL at Home | the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values >250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days post camp (home) compared to 5 days before camp (baseline) |
| Percentage of CGM Values Above 250mg/dL at Camp | the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values >250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
| Percentage of CGM Values Above 300mg/dL at Home | the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values >300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 5 days post camp (home) compared to 5 days before camp (baseline) |
| Percentage of CGM Values Above 300mg/dL at Camp | the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values >300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
| Change in Total Daily Insulin at Home | sum of the recorded insulin injection over the time frame in units | 5 days post camp (home) compared to 5 days before camp (baseline) |
| Change in Total Daily Insulin at Camp | sum of the recorded insulin injection over the time frame in units | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
| Change in Total Meal Carbohydrates at Home | sum of the meal sized recorded over the time frame | 5 days post camp (home) compared to 5 days before camp (baseline) |
| Change in Total Meal Carbohydrates at Camp | sum of the meal sized recorded over the time frame | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) |
| Change in Number of Hypoglycemic Events at Camp | Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL) | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) |
| Number of Hypoglycemia Treatment at Camp | Sum of the number of CHO treatments recorded over the time frame | 2 days during camp admission (Camp) |
| Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp | Sum of the amount of carbohydrates used for treatments recorded over the time frame | 2 days during camp admission (Camp) |
| Change in Hypoglycemia Events at Home | change in number of hypoglycemia between baseline and home | 5 days post camp (home) compared to 5 days before camp (baseline) |
| BG001 | Control-IQ With MyTDI | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control-IQ With MyTDI | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity. |
|
|
|
| Secondary | Average CGM at Home | Average of available CGM values within time frame | Posted | Mean | Standard Deviation | mg/dL | 5 days post camp (home) compared to 5 days before camp (baseline) |
|
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|
|
| Secondary | Average CGM at Camp | average of CGM values within time frame | Posted | Mean | Standard Deviation | mg/dL | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
|
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|
|
| Secondary | Percentage of CGM Values Below 50mg/dL at Home | the percentage of CGM values falling below 50mg/dL, calculated as the number of CGM values <50mg/dL within the time frame divided by the total number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Median | Inter-Quartile Range | percentage | 5 days post camp (home) compared to 5 days before camp (baseline) |
|
|
|
|
| Secondary | Percentage of CGM Values Below 50mg/dL at Camp | the percentage of CGM values falling below 50mg/dL, computed as the number of CGM values <50mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Mean | Standard Deviation | percentage | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) |
|
|
|
| Secondary | Percentage of CGM Values Below 54mg/dL at Camp | the percentage of CGM values falling below 54mg/dL. computed as the number of CGM values <54mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Median | Inter-Quartile Range | percentage | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
|
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|
|
| Secondary | Percentage of CGM Values Below 60mg/dL at Home | the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values <60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Median | Inter-Quartile Range | percentage | 5 days post camp (home) compared to 5 days before camp (baseline) |
|
|
|
|
| Secondary | Percentage of CGM Values Below 60mg/dL at Camp | the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values <60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Median | Inter-Quartile Range | percentage | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) |
|
|
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|
| Secondary | Percentage of CGM Values Below 70mg/dL at Home | the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values <70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Median | Inter-Quartile Range | percentage | 5 days post camp (home) compared to 5 days before camp (baseline) |
|
|
|
|
| Secondary | Percentage of CGM Values Below 70mg/dL at Camp | the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values <70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Median | Inter-Quartile Range | percentage | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) |
|
|
|
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| Secondary | Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp | the percentage of CGM values falling between 70mg/dL and 180mg/dL, computed as the number of CGM values <=180mg/dL and >70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Mean | Standard Deviation | percentage | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
|
|
|
|
| Secondary | Percentage of CGM Values Above 180mg/dL at Home | the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values >180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Mean | Standard Deviation | percentage | 5 days post camp (home) compared to 5 days before camp (baseline) |
|
|
|
|
| Secondary | Percentage of CGM Values Above 180mg/dL at Camp | the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values >180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Mean | Standard Deviation | percentage | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
|
|
|
|
| Secondary | Percentage of CGM Values Above 250mg/dL at Home | the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values >250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Median | Inter-Quartile Range | percentage | 5 days post camp (home) compared to 5 days before camp (baseline) |
|
|
|
|
| Secondary | Percentage of CGM Values Above 250mg/dL at Camp | the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values >250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Mean | Standard Deviation | percentage | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
|
|
|
| Secondary | Percentage of CGM Values Above 300mg/dL at Home | the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values >300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Median | Inter-Quartile Range | percentage | 5 days post camp (home) compared to 5 days before camp (baseline) |
|
|
|
|
| Secondary | Percentage of CGM Values Above 300mg/dL at Camp | the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values >300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated. | Posted | Median | Inter-Quartile Range | percentage | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
|
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| Secondary | Change in Total Daily Insulin at Home | sum of the recorded insulin injection over the time frame in units | Posted | Mean | Standard Deviation | Units | 5 days post camp (home) compared to 5 days before camp (baseline) |
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|
|
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| Secondary | Change in Total Daily Insulin at Camp | sum of the recorded insulin injection over the time frame in units | Posted | Mean | Standard Deviation | Units | 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline) |
|
|
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| Secondary | Change in Total Meal Carbohydrates at Home | sum of the meal sized recorded over the time frame | Posted | Mean | Standard Deviation | Grams | 5 days post camp (home) compared to 5 days before camp (baseline) |
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| Secondary | Change in Total Meal Carbohydrates at Camp | sum of the meal sized recorded over the time frame | Posted | Mean | Standard Deviation | Grams | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) |
|
|
|
|
| Secondary | Change in Number of Hypoglycemic Events at Camp | Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL) | Posted | Median | Inter-Quartile Range | events per day | 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline) |
|
|
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| Secondary | Number of Hypoglycemia Treatment at Camp | Sum of the number of CHO treatments recorded over the time frame | Posted | Median | Inter-Quartile Range | events per day | 2 days during camp admission (Camp) |
|
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| Secondary | Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp | Sum of the amount of carbohydrates used for treatments recorded over the time frame | Posted | Mean | Standard Deviation | grams per day | 2 days during camp admission (Camp) |
|
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| Secondary | Change in Hypoglycemia Events at Home | change in number of hypoglycemia between baseline and home | Posted | Median | Inter-Quartile Range | events per day | 5 days post camp (home) compared to 5 days before camp (baseline) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control-IQ With MyTDI | Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
Control-IQ with MyTDI: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity. | 0 | 10 | 0 | 10 | 1 | 10 |
| Concussion | Nervous system disorders | Systematic Assessment |
|
| Respiratory illness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |