Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Continuous Glucose Monitor (CGM), Tandem t:slim Insulin Pump with Control-IQ Technology, Control-IQ Technology (CIQ), Artificial Pancreas (AP), Artificial Intelligence (AI), Closed loop control (CLC), Diabetes Assistant (DiAs)
Brief summary
The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and efficacy of the use of the AI-driven pump parameters. Participants will use the study system (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.
Detailed description
In this single-arm pilot study of an AI Advisor-driven closed loop system initiation and parameter adaptation in youth age 2 to \<6 years old, participants will use the Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to the University of Virginia (UVA) cloud-based Physician Dashboard for eight weeks at home.The key safety outcomes are adverse events related to hypoglycemia and hyperglycemia, CGM-measured time spent below 54mg/dL, and CGM-measured time spent above 250 mg/dL. CGM-measured endpoints will be tested against baseline for non-inferiority.Glycemic outcomes including time in target range 70-180 mg/dL (TIR) and various other CGM measures of hypo- and hyperglycemia will be assessed and tested for superiority against baseline and a matched historical control population from the prior PEDAP study that did not involve the use of any AI-driven pump parameters. Up to 45 screened participants with the goal of at least 30 participants completing the study pump use period.
Interventions
DEVICEAI-based Advisor system
Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
University of Colorado, Denver
Stanford University
Marc Breton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In this single-arm intervention trial, all participants will use the study system (pump and CGM) in closed-loop mode for 8 weeks.
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 1 month 2. Familiarity and use of a carbohydrate ratio for meal boluses 3. Age ≥2 and \<6 years old 4. Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior 28 days 5. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff 6. Parent/guardian has a phone that can run the Tandem t:connect Mobile App (typically Android 10 or above or iPhone Operating System (iOS) 15 or above) 7. Willingness to use the t:connect Mobile App as needed during the study and ensure connectivity for a data upload at least once per day 8. Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol 9. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study162 provided Tandem pump during the study 10. Total daily insulin dose (TDD) at least 5 Units/day 11. Body weight at least 20 pounds (lbs) 12. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial 13. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff 14. Parent/guardian proficient in reading and writing English 15. Live in the United States, with no plans to move outside the United States during the study period
Exclusion criteria
1. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) 2. Hemophilia or any other bleeding disorder 3. History of \>1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months 4. History of \>1 diabetic ketoacidosis (DKA) event in the last 6 months not related to illness, infusion set failure, or initial diagnosis 5. History of chronic renal disease or currently on hemodialysis 6. History of adrenal insufficiency 7. Hypothyroidism that is not adequately treated in the opinion of the investigator 8. Use of oral or injectable steroids within the last 8 weeks 9. Known, ongoing adhesive intolerance 10. Plans to receive blood transfusions or erythropoietin injections during the course of the study 11. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk 12. Participation in another pharmaceutical or device trial at the time of enrollment or during the study 13. Having immediate family members employed by Tandem Diabetes Care, Inc. or Dexcom, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a) | Baseline and Weeks 1-8 | % of time below 54 mg/dL |
| Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b) | Baseline and Weeks 1-8 | % of time above 250 mg/dL |
| Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a) | Baseline and Weeks 1-8 | % of time in range 70-180 mg/dL |
| Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b) | Baseline and Weeks 1-8 | Mean glucose |
| Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c) | Baseline and Weeks 1-8 | % of time \>250 mg/dL |
| Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d) | Baseline and Weeks 1-8 | % of time \<70 mg/dL |
| Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e) | Baseline and Weeks 1-8 | % of time \<54 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM Measured (g) | Baseline and Weeks 1-8 | The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values \<1 suggest low risk of hypoglycemia. |
| CGM Measured (h) | Baseline and Weeks 1-8 | Weekly hyperglycemic event rate |
| CGM Measured (i) | Baseline and Weeks 1-8 | Weekly hypoglycemic event rate |
| Binary Outcome 1 | Baseline and Weeks 1-8 | Number of participants whose % of time in range 70-180 mg/dL improved by 5% or more from baseline to 8 weeks. |
| CGM Measured Time in Range | Baseline and Weeks 1-8 | % of time spent within range 70 mg/dL-140 mg/dL. |
| Binary Outcome 3 | Baseline and Weeks 1-8 | Participants with % of time in range 70-180 mg/dL \>70% and % of time \<70 mg/dL \<4% |
| Total Daily Insulin | Baseline and Weeks 1-8 | Total daily insulin (units/kg) |
| Basal Insulin | Baseline and Weeks 1-8 | Percentage of total insulin delivered via basal administration. |
| Binary Outcome 2 | Baseline and Weeks 1-8 | Number of participants whose % of time in range 70-180 mg/dL improved by 10% or more from baseline to 8 weeks. |
| CGM Measured (a) | Baseline and Weeks 1-8 | % of time \>180 mg/dL |
| CGM Measured (b) | Baseline and Weeks 1-8 | % of time \>300 mg/dL |
| CGM Measured (c) | Baseline and Weeks 1-8 | % of time \<60 mg/dL |
| CGM Measured (d) | Baseline and Weeks 1-8 | Glucose standard deviation |
| CGM Measured (e) | Baseline and Weeks 1-8 | Glucose coefficient of variation |
| CGM Measured (f) | Baseline and Weeks 1-8 | The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk. |
Countries
United States
Participant flow
Pre-assignment details
Did not meet screening eligibility (N=1)
Participants by arm
| Arm | Count |
|---|---|
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system.
AI-based Advisor system: Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation |
|---|---|
| Age, Customized 2 to <4 years | 9 Participants |
| Age, Customized 4 to <6 years | 23 Participants |
| Annual Household Income $100,000 to <$200,000 | 10 Participants |
| Annual Household Income ≥$200,000 | 11 Participants |
| Annual Household Income $35,000 to <$50,000 | 1 Participants |
| Annual Household Income $50,000 to <$75,000 | 5 Participants |
| Annual Household Income $75,000 to <$100,000 | 4 Participants |
| Annual Household Income Unknown | 1 Participants |
| Body Mass Index Percentile | 76 percentage |
| Diabetes Duration | 10 months |
| Diabetic Ketoacidosis (DKA) in last 12 months No episodes | 24 Participants |
| Diabetic Ketoacidosis (DKA) in last 12 months One episodes | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HbA1c | 7.3 percentage of glycated hemoglobin STANDARD_DEVIATION 0.9 |
| Health Insurance Medicaid | 4 Participants |
| Health Insurance Medicare | 2 Participants |
| Health Insurance Private | 26 Participants |
| Insulin Modality MDI | 20 Participants |
| Insulin Modality Pump | 12 Participants |
| Number of Pump Boluses or Injections of Short-Acting Insulin per Day | 5 Pump boluses per day |
| Parent Education Advanced Degree (e.g. Masters, PhD, MD) | 14 Participants |
| Parent Education Associate Degree (AA) | 4 Participants |
| Parent Education College Graduate (Bachelor's Degree or Equivalent) | 9 Participants |
| Parent Education High school graduate/diploma/GED | 4 Participants |
| Parent Education Technical/Vocational | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Severe hypoglycemia (SH) in Last 12 Months 1 | 0 Participants |
| Severe hypoglycemia (SH) in Last 12 Months None | 32 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 21 Participants |
| Total Daily Insulin | 0.61 U/kg/day STANDARD_DEVIATION 0.21 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 5 / 32 |
| serious Total, serious adverse events | 3 / 32 |
Outcome results
Primary
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a)
% of time in range 70-180 mg/dL
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a) | 63 percentage of time | Standard Deviation 15 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a) | 70 percentage of time | Standard Deviation 8 |
Primary
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b)
Mean glucose
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b) | 168 mg/dl | Standard Deviation 28 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b) | 157 mg/dl | Standard Deviation 14 |
Primary
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c)
% of time \>250 mg/dL
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c) | 13 percentage of time | Standard Deviation 10 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c) | 9 percentage of time | Standard Deviation 5 |
Primary
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d)
% of time \<70 mg/dL
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d) | 2 percentage of time | Standard Deviation 1.4 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d) | 1.7 percentage of time | Standard Deviation 0.9 |
Primary
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e)
% of time \<54 mg/dL
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e) | 0.3 percentage of time | Standard Deviation 0.3 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e) | 0.3 percentage of time | Standard Deviation 0.2 |
Primary
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a)
% of time below 54 mg/dL
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a) | 0.3 percentage of time | Standard Deviation 0.3 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a) | 0.3 percentage of time | Standard Deviation 0.2 |
Primary
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b)
% of time above 250 mg/dL
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b) | 13 percentage of time | Standard Deviation 10 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b) | 9 percentage of time | Standard Deviation 5 |
Secondary
Basal Insulin
Percentage of total insulin delivered via basal administration.
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | Basal Insulin | 39 percentage of total insulin | Standard Deviation 17 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Basal Insulin | 38 percentage of total insulin | Standard Deviation 9 |
Secondary
Binary Outcome 1
Number of participants whose % of time in range 70-180 mg/dL improved by 5% or more from baseline to 8 weeks.
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Period | Binary Outcome 1 | 13 Participants |
Secondary
Binary Outcome 2
Number of participants whose % of time in range 70-180 mg/dL improved by 10% or more from baseline to 8 weeks.
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Period | Binary Outcome 2 | 9 Participants |
Secondary
Binary Outcome 3
Participants with % of time in range 70-180 mg/dL \>70% and % of time \<70 mg/dL \<4%
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Period | Binary Outcome 3 | 10 Participants |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Binary Outcome 3 | 13 Participants |
Secondary
CGM Measured (a)
% of time \>180 mg/dL
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | CGM Measured (a) | 35 percentage of time | Standard Deviation 15 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | CGM Measured (a) | 29 percentage of time | Standard Deviation 8 |
Secondary
CGM Measured (b)
% of time \>300 mg/dL
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | CGM Measured (b) | 5.9 percentage of time | Standard Deviation 5.6 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | CGM Measured (b) | 3.3 percentage of time | Standard Deviation 2.6 |
Secondary
CGM Measured (c)
% of time \<60 mg/dL
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | CGM Measured (c) | 0.7 percentage of time | Standard Deviation 0.5 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | CGM Measured (c) | 0.6 percentage of time | Standard Deviation 0.4 |
Secondary
CGM Measured (d)
Glucose standard deviation
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | CGM Measured (d) | 64 mg/dl | Standard Deviation 16 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | CGM Measured (d) | 59 mg/dl | Standard Deviation 12 |
Secondary
CGM Measured (e)
Glucose coefficient of variation
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | CGM Measured (e) | 38 percent | Standard Deviation 5 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | CGM Measured (e) | 37 percent | Standard Deviation 5 |
Secondary
CGM Measured (f)
The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk.
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | CGM Measured (f) | 8.8 index | Standard Deviation 5 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | CGM Measured (f) | 6.8 index | Standard Deviation 2.5 |
Secondary
CGM Measured (g)
The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values \<1 suggest low risk of hypoglycemia.
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | CGM Measured (g) | 0.6 index | Standard Deviation 0.4 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | CGM Measured (g) | 0.6 index | Standard Deviation 0.2 |
Secondary
CGM Measured (h)
Weekly hyperglycemic event rate
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | CGM Measured (h) | 1.9 events | Standard Deviation 2 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | CGM Measured (h) | 1.1 events | Standard Deviation 1 |
Secondary
CGM Measured (i)
Weekly hypoglycemic event rate
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | CGM Measured (i) | 0.6 events | Standard Deviation 0.6 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | CGM Measured (i) | 0.4 events | Standard Deviation 0.4 |
Secondary
CGM Measured Time in Range
% of time spent within range 70 mg/dL-140 mg/dL.
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | CGM Measured Time in Range | 42 percentage of time | Standard Deviation 14 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | CGM Measured Time in Range | 47 percentage of time | Standard Deviation 9 |
Secondary
Total Daily Insulin
Total daily insulin (units/kg)
Time frame: Baseline and Weeks 1-8
Population: Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Period | Total Daily Insulin | 0.59 U/kg | Standard Deviation 0.2 |
| AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Total Daily Insulin | 0.66 U/kg | Standard Deviation 0.19 |