Trial Outcomes & Findings for Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D) (NCT NCT04016662)
NCT ID: NCT04016662
Last Updated: 2025-01-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
82 participants
Primary outcome timeframe
weeks 5-12 of 12 weeks for each intervention of the crossover
Results posted on
2025-01-15
Participant Flow
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.
Participant milestones
| Measure |
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).
|
|---|---|
|
Run-In Phase
STARTED
|
105
|
|
Run-In Phase
COMPLETED
|
81
|
|
Run-In Phase
NOT COMPLETED
|
24
|
|
HCL (12 Weeks)
STARTED
|
81
|
|
HCL (12 Weeks)
COMPLETED
|
80
|
|
HCL (12 Weeks)
NOT COMPLETED
|
1
|
|
PLGS (12 Weeks)
STARTED
|
80
|
|
PLGS (12 Weeks)
COMPLETED
|
79
|
|
PLGS (12 Weeks)
NOT COMPLETED
|
1
|
|
SAP (12 Weeks)
STARTED
|
79
|
|
SAP (12 Weeks)
COMPLETED
|
78
|
|
SAP (12 Weeks)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Run-In Phase
Death
|
1
|
|
Run-In Phase
Withdrawal by Subject
|
11
|
|
Run-In Phase
Not meeting screening eligibility
|
9
|
|
Run-In Phase
Physician Decision
|
3
|
|
HCL (12 Weeks)
Withdrawal by Subject
|
1
|
|
PLGS (12 Weeks)
Death
|
1
|
|
SAP (12 Weeks)
Death
|
1
|
Baseline Characteristics
Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)
Baseline characteristics by cohort
| Measure |
All Study Participants
n=82 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).
|
|---|---|
|
Age, Customized
65-<70 years
|
38 Participants
n=5 Participants
|
|
Age, Customized
70-<75 years
|
33 Participants
n=5 Participants
|
|
Age, Customized
75-<80 years
|
9 Participants
n=5 Participants
|
|
Age, Customized
≥80 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
|
Central Lab Baseline HbA1c (%)
|
7.2 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: weeks 5-12 of 12 weeks for each intervention of the crossoverPrimary 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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=81 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=78 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
CGM Measured Time <70 mg/dL
|
1.58 % time <70 mg/dL
Standard Deviation 0.95
|
1.67 % time <70 mg/dL
Standard Deviation 0.96
|
2.57 % time <70 mg/dL
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: weeks 5-12 of 12 weeks for each intervention of the crossoverPercentage 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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=81 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=78 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
CGM Measured Time <54 mg/dL
|
0.29 % time <54 mg/dL
Standard Deviation 0.23
|
0.27 % time <54 mg/dL
Standard Deviation 0.20
|
0.48 % time <54 mg/dL
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: weeks 5-12 of 12 weeks for each arm of the crossoverRate 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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=81 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=78 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
Hypoglycemia
|
0.6 hypoglycemic events per week
Standard Deviation 0.5
|
0.5 hypoglycemic events per week
Standard Deviation 0.5
|
0.9 hypoglycemic events per week
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: weeks 5-12 of 12 weeks for each arm of the crossoverMean glucose (mg/dL)
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=81 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=78 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
Glucose Control
|
152 mg/dL
Standard Deviation 16
|
161 mg/dL
Standard Deviation 23
|
160 mg/dL
Standard Deviation 20
|
SECONDARY outcome
Timeframe: weeks 5-12 of 12 weeks for each intervention of the crossoverPercentage 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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=81 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=78 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
% Time 70-180 mg/dL
|
74 % time in range 70-180 mg/dL
Standard Deviation 10
|
67 % time in range 70-180 mg/dL
Standard Deviation 14
|
66 % time in range 70-180 mg/dL
Standard Deviation 12
|
SECONDARY outcome
Timeframe: weeks 5-12 of 12 weeks for each arm of the crossoverCoefficient of variation (%)
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=81 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=78 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
Glucose Control - Coefficient of Variation
|
33 % coefficient of variation
Standard Deviation 5
|
35 % coefficient of variation
Standard Deviation 4
|
36 % coefficient of variation
Standard Deviation 5
|
SECONDARY outcome
Timeframe: weeks 5-12 of 12 weeks for each intervention of the crossoverPercentage 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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=81 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=78 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
% Time > 180 mg/dL
|
24 % of time >180 mg/dL
Standard Deviation 10
|
31 % of time >180 mg/dL
Standard Deviation 14
|
31 % of time >180 mg/dL
Standard Deviation 13
|
SECONDARY outcome
Timeframe: weeks 5-12 of 12 weeks for each intervention of the crossoverPercentage 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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=81 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=78 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
% Time > 250 mg/dL
|
5.6 % of time >250 mg/dL
Standard Deviation 5.2
|
8.7 % of time >250 mg/dL
Standard Deviation 8.8
|
8.6 % of time >250 mg/dL
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: at 12 week visit for each arm of the crossoverHbA1c %
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=75 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=73 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=70 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
HbA1c
|
6.9 % of HbA1c
Standard Deviation 0.7
|
7.1 % of HbA1c
Standard Deviation 0.8
|
7.0 % of HbA1c
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: at 12 week visit for each arm of the crossoverThe 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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=78 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=76 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
Hypoglycemia Unawareness - Gold Survey
|
2.6 score on a scale
Standard Deviation 1.6
|
2.7 score on a scale
Standard Deviation 1.5
|
2.9 score on a scale
Standard Deviation 1.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 12 week visit for each arm of the crossoverThe 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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=68 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=69 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=64 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
Patient Reported Questionnaires - Hypoglycemia Fear Survey
|
0.9 score on a scale
Standard Deviation 0.6
|
1.0 score on a scale
Standard Deviation 0.6
|
1.0 score on a scale
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 12 week visit for each arm of the crossoverThe 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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=68 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=69 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=64 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
Patient Reported Questionnaires - Hypoglycemia Confidence
|
3.4 score on a scale
Standard Deviation 0.5
|
3.4 score on a scale
Standard Deviation 0.5
|
3.4 score on a scale
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 12 week visit for each arm of the crossover28-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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=68 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=69 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=64 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
Patient Reported Questionnaires - Diabetes Distress Scale
|
1.6 score on a scale
Standard Deviation 0.5
|
1.7 score on a scale
Standard Deviation 0.5
|
1.6 score on a scale
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 12 week visit for each arm of the crossoverThis 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.
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=68 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=68 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=63 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
Patient Reported Questionnaires - AIDE Technology Acceptance
|
4.1 score on a scale
Standard Deviation 0.6
|
4.0 score on a scale
Standard Deviation 0.7
|
3.9 score on a scale
Standard Deviation 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 12 week visit for each arm of the crossoverA 10-item questionnaire that measures overall perceived usability of a system and is technology-agnostic. Score scale 0-100; Higher score indicates better usability
Outcome measures
| Measure |
Hybrid Closed Loop Control (HCL)
n=68 Participants
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=69 Participants
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.
|
Sensor-Augmented Pump (SAP)
n=64 Participants
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|
|
Patient Reported Questionnaires - System Usability
|
77 score on a scale
Standard Deviation 17
|
76 score on a scale
Standard Deviation 17
|
73 score on a scale
Standard Deviation 16
|
Adverse Events
Run-In Phase
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Hybrid Closed Loop Control (HCL)
Serious events: 8 serious events
Other events: 4 other events
Deaths: 0 deaths
Predictive Low-Glucose Insulin Suspension (PLGS)
Serious events: 3 serious events
Other events: 16 other events
Deaths: 1 deaths
Sensor-Augmented Pump (SAP)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Run-In Phase
n=105 participants at risk
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.
|
Hybrid Closed Loop Control (HCL)
n=81 participants at risk
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 participants at risk
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.
|
Sensor-Augmented Pump (SAP)
n=78 participants at risk
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Diabetic ketoacidosis
|
0.95%
1/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
2.5%
2/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
0.95%
1/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.2%
1/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
2.6%
2/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.2%
1/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
General disorders
Osteomyelitis
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.2%
1/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Blood and lymphatic system disorders
Severe hypoglycemia
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.2%
1/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
General disorders
Fluid overload
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.2%
1/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Blood and lymphatic system disorders
Ketosis
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.2%
1/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
General disorders
Peripheral arterial disease
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Blood and lymphatic system disorders
Intracranial hemorrhage
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
Other adverse events
| Measure |
Run-In Phase
n=105 participants at risk
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.
|
Hybrid Closed Loop Control (HCL)
n=81 participants at risk
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.
|
Predictive Low-Glucose Insulin Suspension (PLGS)
n=79 participants at risk
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.
|
Sensor-Augmented Pump (SAP)
n=78 participants at risk
The SAP arm will utilize the Tandem t:slim X2 without HCL or PLGS features turned on and Dexcom G6 CGM
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.2%
1/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
2.9%
3/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.2%
1/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
8.9%
7/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
5.1%
4/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
General disorders
Fall
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.2%
1/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
5.1%
4/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.2%
1/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
General disorders
Gastroenteritis
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
General disorders
Wound
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
2.5%
2/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Blood and lymphatic system disorders
Ketosis
|
0.95%
1/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Injury, poisoning and procedural complications
Foot injury
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
General disorders
Edema
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
General disorders
Abdominal pain
|
0.00%
0/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
1.3%
1/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.95%
1/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
General disorders
Rectal Bleeding
|
0.95%
1/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
|
Cardiac disorders
Palpitation
|
0.95%
1/105 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/81 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/79 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
0.00%
0/78 • Adverse events were collected throughout the entirety of the study for the participant (e.g. ~54 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place