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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| DexCom, Inc. | INDUSTRY |
| Tandem Diabetes Care, Inc. | INDUSTRY |
| University of Minnesota - Advanced Research and Diagnostic Laboratory |
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A multi-center, randomized, crossover trial consisting of three sequential 12-week periods, with the HCL feature used during one period, the PLGS feature used during one period and SAP therapy (control) during one period. The crossover trial will be preceded by a run-in phase in which participants will receive training using the study devices (Dexcom G6 and Tandem t:slim X2 pump). After the last crossover period, participants will be given the opportunity to use study devices for an additional 12 weeks to assess preference of system use (PLGS, HCL or SAP) and associated characteristics, durability and safety in a more real-world setting with less frequent study contact.
Automated insulin delivery (AID) technologies hold the promise of optimizing glycemic control and reducing the burden of diabetes care for patients with Type 1 Diabetes (T1D). However, clinical trials of lower burden AID technologies have not included older adults in sufficient numbers to allow for focused evaluation of efficacy and quality of life (QOL) impacts that may differ from those observed in younger age groups. Most notably, primary endpoints have focused on reducing hyperglycemia, while avoidance of hypoglycemia is of upmost concern for older adults with T1D. T1D Exchange clinic registry data have shown severe hypoglycemia (SH) occurs more commonly in older adults with longstanding T1D than in younger individuals with events occurring just as often with HbA1c levels >8.0% as with HbA1c levels <7.0%. These data do not support the strategy of "raising the HbA1c" as being an effective approach for hypoglycemia prevention in older adults with T1D. In addition to acutely altered mental status, hypoglycemia is associated with an increased risk for falls leading to fractures, car accidents, emergency room (ER) visits, hospitalizations, and mortality resulting in substantial societal costs. The occurrence of hypoglycemia, hypoglycemia unawareness and fear of hypoglycemia have adverse effects on overall QOL of both individuals with T1D and their families.
While continuous glucose monitoring (CGM) technology alone has the potential to be beneficial in reducing hypoglycemia in older patients, our preliminary data from the Wireless Innovations for Seniors with Diabetes Mellitus (WISDM) trial shows a majority of patients still have frequent hypoglycemia even when using CGM. Thus, knowledge of CGM alone may not be sufficient to avoid hypoglycemia in this population. Predictive low-glucose suspend algorithms have particular promise when the primary goal is hypoglycemia avoidance rather than glucose reduction. Whether the added complexity of closed loop systems provides additional glycemic benefit is not known. There is a critical need to determine whether automated insulin delivery can reduce hypoglycemia in the older adult population with T1D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Closed Loop Control (HCL) | Active Comparator | The HCL intervention arm will utilize the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM |
|
| Predictive Low-Glucose Insulin Suspension (PLGS) | Active Comparator | The PLGS intervention arm will utilize the Tandem t:slim X2 with Basal-IQ Technology and Dexcom G6 CGM |
|
| Sensor-Augmented Pump (SAP) | No Intervention | The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem t:slim X2 with HCL or PLGS | Device | The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop). The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands. |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Measured Time <70 mg/dL | Primary Outcome: Percentage of sensor glucose values <70 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. Since the hypoglycemia endpoints had skewed distributions, values were winsorized at the 10th and 90th percentiles. | weeks 5-12 of 12 weeks for each intervention of the crossover |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Measured Time <54 mg/dL | Percentage of sensor glucose values <54 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. Since the hypoglycemia endpoints had skewed distributions, values were winsorized at the 10th and 90th percentiles. | weeks 5-12 of 12 weeks for each intervention of the crossover |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Questionnaires - Hypoglycemia Fear Survey | The Hypoglycemia Fear Survey measures several dimensions of fear of hypoglycemia among adults with type 1 diabetes. It consists of a 15-item Behavior subscale that measures behaviors involved in avoidance and over-treatment of hypoglycemia and a 18-item Worry subscale that measures anxiety and fear surrounding hypoglycemia. Scores will be calculated overall and for the worry subscale. Score scale 0-4; A higher score indicates more fear. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Henderson, MS | Jaeb Center for Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Diabetes Institute | Orlando | Florida | 32803 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40067490 | Derived | Kudva YC, Henderson RJ, Kanapka LG, Weinstock RS, Rickels MR, Pratley RE, Chaytor N, Janess K, Desjardins D, Pattan V, Peleckis AJ, Casu A, Rizvi SR, Bzdick S, Whitaker KJ, Kamimoto JLJ, Miller K, Kollman C, Beck RW; AIDE Study Group. Automated Insulin Delivery in Elderly with Type 1 Diabetes: A Prespecified Analysis of the Extension Phase. Diabetes Technol Ther. 2025 Jul;27(7):572-575. doi: 10.1089/dia.2024.0560. Epub 2025 Mar 11. | |
| 39714936 |
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deidentified data will be shared on the JCHR website
The data will be available after publication of the primary manuscript and will remain available in perpetuity
users must have a valid email address
This was a crossover study, so the same 82 randomized patients participated in each arm. If they drop out, they might not be in one of the arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All participants were randomized to receive all interventions: Hybrid Closed Loop Control (HCL), Predictive Low-Glucose Insulin Suspension (PLGS), and Sensor-Augmented Pump (SAP). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-In Phase |
|
| ||||||||||||||||||||||||
| HCL (12 Weeks) |
| |||||||||||||||||||||||||
| PLGS (12 Weeks) |
| |||||||||||||||||||||||||
| SAP (12 Weeks) |
|
The same 82 patients at baseline participated in each arm unless they dropped or there was a death.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants were randomized to receive all interventions: Hybrid Closed Loop Control (HCL), Predictive Low-Glucose Insulin Suspension (PLGS), and Sensor-Augmented Pump (SAP). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | CGM Measured Time <70 mg/dL | Primary Outcome: Percentage of sensor glucose values <70 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. Since the hypoglycemia endpoints had skewed distributions, values were winsorized at the 10th and 90th percentiles. | Posted | Mean | Standard Deviation | % time <70 mg/dL | weeks 5-12 of 12 weeks for each intervention of the crossover |
|
Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 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 | Run-In Phase | Run-In Phase precedes the randomized assigned treatment groups and includes the CGM Training Period, SAP Training Period, and SAP Evaluation. Length of run-in phase varied depending on participant's prior experience with devices. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Henderson | Jaeb Center for Health Research | (813) 975-8690 | Rhenderson@jaeb.org |
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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 | May 5, 2021 | Oct 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2023 | Feb 29, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2021 | Oct 5, 2023 | ICF_002.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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| UNKNOWN |
| Mayo Clinic | OTHER |
| University of Pennsylvania | OTHER |
| AdventHealth Diabetes Institute | UNKNOWN |
| Washington State University | OTHER |
Randomized crossover trial with three 12-week crossover periods (HCL during one period, PLGS during one period, and SAP therapy (control) during one period) preceded by a run-in phase.
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|
|
| Hypoglycemia | Rate of CGM-measured hypoglycemic events per week. A hypoglycemic event is defined as 15 consecutive minutes with a sensor glucose value <54 mg/dl. At least 2 sensor values <54 mg/dl that are 15 or more minutes apart plus no intervening values >54 mg/dl are required to define an event. The end of the hypoglycemic event is defined as a minimum of 15 consecutive minutes with a sensor glucose concentration >70 mg/dl. At least 2 sensor values >70 mg/dl that are 15 or more minutes apart with no intervening values <70 mg/dl, are required to define the end of an event. When a hypoglycemic event ends, the study participant becomes eligible for a new event. | weeks 5-12 of 12 weeks for each arm of the crossover |
| Glucose Control | Mean glucose (mg/dL) | weeks 5-12 of 12 weeks for each arm of the crossover |
| % Time 70-180 mg/dL | Percentage of sensor glucose values 70 to 180 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. | weeks 5-12 of 12 weeks for each intervention of the crossover |
| Glucose Control - Coefficient of Variation | Coefficient of variation (%) | weeks 5-12 of 12 weeks for each arm of the crossover |
| % Time > 180 mg/dL | Percentage of values >180 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. | weeks 5-12 of 12 weeks for each intervention of the crossover |
| % Time > 250 mg/dL | Percentage of values >250 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. | weeks 5-12 of 12 weeks for each intervention of the crossover |
| HbA1c | HbA1c % | at 12 week visit for each arm of the crossover |
| Hypoglycemia Unawareness - Gold Survey | The Gold score asks subjects to indicate their awareness of hypoglycemia with '1' being always aware and '7' being never aware. Score scale 1-7; A higher score indicates more unawareness. | at 12 week visit for each arm of the crossover |
| at 12 week visit for each arm of the crossover |
| Patient Reported Questionnaires - Hypoglycemia Confidence | The HCS is a 9-item scale that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems. Score scale 1-4.; A higher score indicates more confidence. | at 12 week visit for each arm of the crossover |
| Patient Reported Questionnaires - Diabetes Distress Scale | 28-item questionnaire used to measure diabetes-related concerns about powerlessness, management, hypoglycemia, social perceptions, eating, physician, and friends/family. Score scale 1-6; A higher score indicates more distress. | at 12 week visit for each arm of the crossover |
| Patient Reported Questionnaires - AIDE Technology Acceptance | This diabetes technology specific questionnaire based on the Technology Acceptance Model, assesses perceived system usefulness, ease of use and trust in the system. Score scale 1-5; A higher score indicates a more positive appraisal of the system. | at 12 week visit for each arm of the crossover |
| Patient Reported Questionnaires - System Usability | A 10-item questionnaire that measures overall perceived usability of a system and is technology-agnostic. Score scale 0-100; Higher score indicates better usability | at 12 week visit for each arm of the crossover |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| SUNY Upstate | Syracuse | New York | 13214 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Derived |
| Kudva YC, Henderson RJ, Kanapka LG, Weinstock RS, Rickels MR, Pratley RE, Chaytor N, Janess K, Desjardins D, Pattan V, Peleckis AJ, Casu A, Rizvi SR, Bzdick S, Whitaker KJ, Jo Kamimoto JL, Miller K, Kollman C, Beck RW. Automated Insulin Delivery in Older Adults with Type 1 Diabetes. NEJM Evid. 2025 Jan;4(1):EVIDoa2400200. doi: 10.1056/EVIDoa2400200. Epub 2024 Dec 23. |
| Physician Decision |
|
|
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Central Lab Baseline HbA1c (%) | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
| OG001 | Predictive Low-Glucose Insulin Suspension (PLGS) | The PLGS intervention arm will utilize the Tandem t:slim X2 with Basal-IQ Technology and Dexcom G6 CGM Tandem t:slim X2 with HCL or PLGS: The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop). The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands. |
| OG002 | Sensor-Augmented Pump (SAP) | The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM |
|
|
| Secondary | CGM Measured Time <54 mg/dL | Percentage of sensor glucose values <54 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. Since the hypoglycemia endpoints had skewed distributions, values were winsorized at the 10th and 90th percentiles. | Posted | Mean | Standard Deviation | % time <54 mg/dL | weeks 5-12 of 12 weeks for each intervention of the crossover |
|
|
|
| Secondary | Hypoglycemia | Rate of CGM-measured hypoglycemic events per week. A hypoglycemic event is defined as 15 consecutive minutes with a sensor glucose value <54 mg/dl. At least 2 sensor values <54 mg/dl that are 15 or more minutes apart plus no intervening values >54 mg/dl are required to define an event. The end of the hypoglycemic event is defined as a minimum of 15 consecutive minutes with a sensor glucose concentration >70 mg/dl. At least 2 sensor values >70 mg/dl that are 15 or more minutes apart with no intervening values <70 mg/dl, are required to define the end of an event. When a hypoglycemic event ends, the study participant becomes eligible for a new event. | Posted | Mean | Standard Deviation | hypoglycemic events per week | weeks 5-12 of 12 weeks for each arm of the crossover |
|
|
|
| Secondary | Glucose Control | Mean glucose (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | weeks 5-12 of 12 weeks for each arm of the crossover |
|
|
|
| Secondary | % Time 70-180 mg/dL | Percentage of sensor glucose values 70 to 180 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. | Posted | Mean | Standard Deviation | % time in range 70-180 mg/dL | weeks 5-12 of 12 weeks for each intervention of the crossover |
|
|
|
| Secondary | Glucose Control - Coefficient of Variation | Coefficient of variation (%) | Posted | Mean | Standard Deviation | % coefficient of variation | weeks 5-12 of 12 weeks for each arm of the crossover |
|
|
|
| Secondary | % Time > 180 mg/dL | Percentage of values >180 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. | Posted | Mean | Standard Deviation | % of time >180 mg/dL | weeks 5-12 of 12 weeks for each intervention of the crossover |
|
|
|
| Secondary | % Time > 250 mg/dL | Percentage of values >250 mg/dL. The first 4 weeks of CGM data in each period were excluded to reduce the chance of a carryover effect. A minimum of 168 hours of data was required to calculate CGM metrics. | Posted | Mean | Standard Deviation | % of time >250 mg/dL | weeks 5-12 of 12 weeks for each intervention of the crossover |
|
|
|
| Secondary | HbA1c | HbA1c % | Posted | Mean | Standard Deviation | % of HbA1c | at 12 week visit for each arm of the crossover |
|
|
|
| Secondary | Hypoglycemia Unawareness - Gold Survey | The Gold score asks subjects to indicate their awareness of hypoglycemia with '1' being always aware and '7' being never aware. Score scale 1-7; A higher score indicates more unawareness. | Posted | Mean | Standard Deviation | score on a scale | at 12 week visit for each arm of the crossover |
|
|
|
| Other Pre-specified | Patient Reported Questionnaires - Hypoglycemia Fear Survey | The Hypoglycemia Fear Survey measures several dimensions of fear of hypoglycemia among adults with type 1 diabetes. It consists of a 15-item Behavior subscale that measures behaviors involved in avoidance and over-treatment of hypoglycemia and a 18-item Worry subscale that measures anxiety and fear surrounding hypoglycemia. Scores will be calculated overall and for the worry subscale. Score scale 0-4; A higher score indicates more fear. | Posted | Mean | Standard Deviation | score on a scale | at 12 week visit for each arm of the crossover |
|
|
|
| Other Pre-specified | Patient Reported Questionnaires - Hypoglycemia Confidence | The HCS is a 9-item scale that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems. Score scale 1-4.; A higher score indicates more confidence. | Posted | Mean | Standard Deviation | score on a scale | at 12 week visit for each arm of the crossover |
|
|
|
| Other Pre-specified | Patient Reported Questionnaires - Diabetes Distress Scale | 28-item questionnaire used to measure diabetes-related concerns about powerlessness, management, hypoglycemia, social perceptions, eating, physician, and friends/family. Score scale 1-6; A higher score indicates more distress. | Posted | Mean | Standard Deviation | score on a scale | at 12 week visit for each arm of the crossover |
|
|
|
| Other Pre-specified | Patient Reported Questionnaires - AIDE Technology Acceptance | This diabetes technology specific questionnaire based on the Technology Acceptance Model, assesses perceived system usefulness, ease of use and trust in the system. Score scale 1-5; A higher score indicates a more positive appraisal of the system. | Posted | Mean | Standard Deviation | score on a scale | at 12 week visit for each arm of the crossover |
|
|
|
| Other Pre-specified | Patient Reported Questionnaires - System Usability | A 10-item questionnaire that measures overall perceived usability of a system and is technology-agnostic. Score scale 0-100; Higher score indicates better usability | Posted | Mean | Standard Deviation | score on a scale | at 12 week visit for each arm of the crossover |
|
|
|
| 1 |
| 105 |
| 2 |
| 105 |
| 7 |
| 105 |
| EG001 | Hybrid Closed Loop Control (HCL) | The HCL intervention arm will utilize the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM Tandem t:slim X2 with HCL or PLGS: The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop). The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands. | 0 | 81 | 8 | 81 | 4 | 81 |
| EG002 | Predictive Low-Glucose Insulin Suspension (PLGS) | The PLGS intervention arm will utilize the Tandem t:slim X2 with Basal-IQ Technology and Dexcom G6 CGM Tandem t:slim X2 with HCL or PLGS: The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop). The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands. | 1 | 80 | 3 | 79 | 16 | 79 |
| EG003 | Sensor-Augmented Pump (SAP) | The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM | 1 | 79 | 3 | 78 | 10 | 78 |
| Hypoglycemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hyperglycemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Osteomyelitis | General disorders | Non-systematic Assessment |
|
| Severe hypoglycemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Fluid overload | General disorders | Non-systematic Assessment |
|
| Ketosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Peripheral arterial disease | General disorders | Systematic Assessment | The participant was admitted to the hospital for an elective procedure |
|
| Intracranial hemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hyperglycemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Fall | General disorders | Non-systematic Assessment |
|
| Hypoglycemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Gastroenteritis | General disorders | Non-systematic Assessment |
|
| Wound | General disorders | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Ketosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Foot injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Edema | General disorders | Non-systematic Assessment |
|
| Abdominal pain | General disorders | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Rectal Bleeding | General disorders | Non-systematic Assessment |
|
| Palpitation | Cardiac disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |