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| Name | Class |
|---|---|
| Jaeb Center for Health Research | OTHER |
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A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth > 6 years old with type 1 diabetes (T1D).
Screening and Enrollment
CGM and (Sensor Augmented Pump) SAP Training Period at Home All eligible participants will be assessed based on their CGM and pump experience to determine if the CGM Training Period, the SAP Training Period, or both are required.
i. The Tandem SAP pump will be used during the SAP Training Period and pump training will be customized based on prior pump experience
PLGS Pilot Phase Prior to the initiation of the crossover trial, 10 adult participants will use the Tandem PLGS pump and CGM system in a 10-day Pilot Period. Data will be evaluated for system usability and predetermined safety metrics before participants ≥12 years old can be randomized into the crossover trial.
Randomized Crossover Trial The crossover trial will begin after the data from the Pilot Period have been reviewed. Enrollment of participants 6 to 11 years old will be deferred until data from 100 post-randomization PLGS participant-days have been evaluated from participants 12 to 17 years old and the same predetermined safety metrics used to evaluate the Pilot Period have been satisfied.
At the Crossover Trial initiation visit, the following will be done:
During each of the two 3-week periods, a phone, email, or text contact will occur at 2 and 14 days, and a clinic visit at 7 and 21 days. HbA1c will be measured at the end of each period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. |
|
| Control Arm | No Intervention | The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Predictive Low Glucose Suspend | Device | Application of Predictive Low Glucose Suspend |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia < 70 mg/dL | Percentage of time CGM <70 mg/dL | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia <60 mg/dL | Percentage of time CGM <60 mg/dL | 3 weeks |
| Hypoglycemia <50 mg/dL | Percentage of time CGM <50 mg/dL | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Buckingham, MD | Stanford University | Principal Investigator |
| Vance Swanson | Tandem Diabetes Care, Inc. | Study Chair |
| John Lum, MS | JCHR | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| William Sansum Diabetes Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30089663 | Result | Forlenza GP, Li Z, Buckingham BA, Pinsker JE, Cengiz E, Wadwa RP, Ekhlaspour L, Church MM, Weinzimer SA, Jost E, Marcal T, Andre C, Carria L, Swanson V, Lum JW, Kollman C, Woodall W, Beck RW. Predictive Low-Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized Crossover Study: Results of the PROLOG Trial. Diabetes Care. 2018 Oct;41(10):2155-2161. doi: 10.2337/dc18-0771. Epub 2018 Aug 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PLGS First, Then SAP | Participants were randomized to use the Predictive Low-Glucose Suspend (PLGS) system first for 3 weeks, then the switch to the sensor-augmented pump (SAP) arm for 3 weeks. |
| FG001 | SAP First, Then PLGS | Participants were randomized to use the sensor-augmented pump (SAP) system first for 3 weeks, then the switch to the Predictive Low-Glucose Suspend (PLGS) arm for 3 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PLGS First, Then SAP | Participants were randomized to use the Predictive Low-Glucose Suspend (PLGS) system first for 3 weeks, then the switch to the sensor-augmented pump (SAP) arm for 3 weeks. |
| BG001 | SAP First, Then PLGS |
| 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 | Hypoglycemia < 70 mg/dL | Percentage of time CGM <70 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | 3 weeks |
|
3 weeks
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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 | Intervention Arm | The intervention arm (use of PLGS feature). | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ketosis | Endocrine disorders | Non-systematic Assessment | At least one day with ketones > 1.0 mmol/L |
1 participant did not have baseline data available, so outcome measures report on 102 of the 103 participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Pinsker, MD | Tandem Diabetes Care, Inc | 858-366-6900 | clinicalaffairs@tandemdiabetes.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2018 | Aug 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2018 | Aug 29, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Multi-center, randomized, crossover design, consisting of two 3-week periods, with the PLGS System used during one period and SAP therapy used during the other period. The crossover trial will be preceded by a run-in phase in which participants may receive training using the study devices.
For 10 adult participants, a PLGS Pilot Period will proceed to the crossover trial to ensure safety and usability objectives are met prior to the start of the crossover trial.
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| Hypoglycemia AOC <70 mg/dL | Area Over Curve (AOC) <70 mg/dL | 3 weeks |
| Low Blood Glucose Index (LBGI) | Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia. | 3 weeks |
| Hypoglycemic Events Per Week | A hypoglycemia event was defined as at least two sensor values <54 mg/dL that were ≥15 min apart with no intervening values >54 mg/dL. At least two sensor values >70 mg/dL that are ≥30 min apart with no intervening values <70 mg/dL are required to end a hypoglycemic event. | 3 weeks |
| Time in Range 70-180 mg/dL | Percentage of time CGM in range 70 to 180 mg/dL | 3 weeks |
| Hyperglycemia >250 mg/dL | Percentage of time CGM >250 mg/dL | 3 weeks |
| Hyperglycemia >180 mg/dL | Percentage of time CGM >180 mg/dL | 3 weeks |
| Area Under Curve >180 mg/dL | Hyperglycemia Area Under Curve of CGM >180 mg/dL | 3 weeks |
| High Blood Glucose Index (HBGI) | High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia | 3 weeks |
| Santa Barbara |
| California |
| 93105 |
| United States |
| Barbara Davis Center | Aurora | Colorado | 80045 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
Participants were randomized to use the sensor-augmented pump (SAP) system first for 3 weeks, then the switch to the Predictive Low-Glucose Suspend (PLGS) arm for 3 weeks.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Control Arm |
The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump. |
|
|
| Secondary | Hypoglycemia <60 mg/dL | Percentage of time CGM <60 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | 3 weeks |
|
|
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| Secondary | Hypoglycemia <50 mg/dL | Percentage of time CGM <50 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | 3 weeks |
|
|
|
| Secondary | Hypoglycemia AOC <70 mg/dL | Area Over Curve (AOC) <70 mg/dL | Posted | Median | Inter-Quartile Range | mg*hr/dL | 3 weeks |
|
|
|
| Secondary | Low Blood Glucose Index (LBGI) | Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia. | Posted | Median | Inter-Quartile Range | index score | 3 weeks |
|
|
|
| Secondary | Hypoglycemic Events Per Week | A hypoglycemia event was defined as at least two sensor values <54 mg/dL that were ≥15 min apart with no intervening values >54 mg/dL. At least two sensor values >70 mg/dL that are ≥30 min apart with no intervening values <70 mg/dL are required to end a hypoglycemic event. | Posted | Median | Inter-Quartile Range | events/week | 3 weeks |
|
|
|
| Secondary | Time in Range 70-180 mg/dL | Percentage of time CGM in range 70 to 180 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 3 weeks |
|
|
|
| Secondary | Hyperglycemia >250 mg/dL | Percentage of time CGM >250 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time | 3 weeks |
|
|
|
| Secondary | Hyperglycemia >180 mg/dL | Percentage of time CGM >180 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 3 weeks |
|
|
|
| Secondary | Area Under Curve >180 mg/dL | Hyperglycemia Area Under Curve of CGM >180 mg/dL | Posted | Median | Inter-Quartile Range | mg*hr/dL | 3 weeks |
|
|
|
| Secondary | High Blood Glucose Index (HBGI) | High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia | Posted | Median | Inter-Quartile Range | index score | 3 weeks |
|
|
|
| 103 |
| 0 |
| 103 |
| 58 |
| 103 |
| EG001 | Control Arm | The control arm (SAP only). | 0 | 103 | 2 | 103 | 59 | 103 |
| Severe Hypoglycemia | Endocrine disorders | Systematic Assessment |
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|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |