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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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The purpose of this study is to assess the use of once weekly semaglutide injection in inadequately controlled obese adults with type 1 diabetes (T1D) using FDA-approved hybrid closed-loop therapies.
After being informed about the study and potential risks, all patients given written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner using computer generated randomization scheme to receive either semaglutide or placebo (1:1 ratio) for 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy |
|
| Control | Placebo Comparator | Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Semaglutide up to 1 mg per week in addition to standard closed-loop therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group | Primary outcome will be analyzed per statistical analysis plan using intention to treat basis. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | HbA1c will be measured at a central laboratory and change in Hba1c from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | 26 weeks |
| Change in Mean Glucose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Reported Quality of Life | Patient reported quality of life will be measured using a validated instrument (ADDQOL) and the change in score from baseline to 26 weeks will be compared by randomization group using an ITT analysis. | 26 weeks |
| Proportion of Participants With HbA1c <7% |
Inclusion Criteria:
For an eligible subject, all inclusion criteria must be answered "yes"
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Viral N Shah, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | United States | ||
| Iowa Diabetes Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40550013 | Derived | Shah VN, Akturk HK, Kruger D, Ahmann A, Bhargava A, Bakoyannis G, Pyle L, Snell-Bergeon JK. Semaglutide in Adults with Type 1 Diabetes and Obesity. NEJM Evid. 2025 Aug;4(8):EVIDoa2500173. doi: 10.1056/EVIDoa2500173. Epub 2025 Jun 23. |
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IPD may be available once the study is completed and all results are published.
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| ID | Title | Description |
|---|---|---|
| FG000 | Semaglutide | Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy |
| FG001 | Control | Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Semaglutide | Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group | Primary outcome will be analyzed per statistical analysis plan using intention to treat basis. | Posted | Count of Participants | Participants | 26 weeks |
|
from signing consent from till end of the study (i.e 26 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Semaglutide | Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy Semaglutide: Semaglutide up to 1 mg per week in addition to standard closed-loop therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea & vomiting | Gastrointestinal disorders | Systematic Assessment | Severe GI event leading to hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal events | Gastrointestinal disorders | Systematic Assessment | GI event: nausea, vomiting, reflux (gastrointestinal reflux disease), burping or belching, diarrhea, constipation, loss of appetite, and elevated levels of liver enzymes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Viral N Shah, MD | Indiana University School of Medicine | 317-278-6017 | shahvi@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2024 | Jul 27, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Placebo | Drug | Injection placebo up to 1 mg per week in addition to standard closed-loop therapy |
|
Mean glucose (mg/dL) will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
| 26 weeks |
| Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR) | Percent of time spent in tight glucose range (70-140 mg/dL) will be obtained by CGM and change in percent time in range from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | 26 weeks |
| Percent Time Spent in CGM-measured Glucose >180 mg/dL | Percent of time spent in glucose range >180 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | 26 weeks |
| Percent Time Spent in CGM-measured Glucose >250mg/dL | Percent of time spent in glucose range >250 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | 26 weeks |
| Percent Time Spent in CGM-measured Glucose <70mg/dL | Percent of time spent in glucose range <70 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | 26 weeks |
| Change in CGM Measured Glycemic Variability (Coefficient of Variation) | Glucose coefficient of variation (mg/dL) will be obtained by CGM and change in glucose CV from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | 26 weeks |
| Change in Weight | The change in kg of body weight from baseline to 26 weeks will be compared by randomization group using an ITT analysis. | 26 weeks |
| Change in BMI (Kg/m2) | Change in body mass index (BMI) calculated as kg body weight per meter squared of height from baseline to 26 weeks will be compared by randomization group using an ITT analysis. | 26 weeks |
| Severe Hypoglycemia | SH events in number of patients per group | 26 weeks |
proportion (N, %) of participants achieving HbA1c <7% between two groups over 26 weeks |
| 26 weeks |
| Proportion of Participants With HbA1c <7.5% | proportion (N, %) of participants achieving HbA1c <7.5% between two groups over 26 weeks | 26 weeks |
| HbA1c Improvement | HbA1c improvement from baseline to 26 weeks between two groups | 26 weeks |
| HbA1c Improvement of >0.4% From Baseline | proportion of participants with HbA1c improvement of >0.4% from baseline between two groups | 26 weeks |
| Proportion of Participants Achieving TIR >70% | Proportion of participants achieving TIR >70% between two groups over 26 weeks | 26 weeks |
| Proportion of Participants Achieving TITR >50% | Proportion of participants achieving TITR (time in 70-140 mg/dL) >50% between two groups | 26 weeks |
| Proportion of Participants Achieving TIR >80% | Proportion of participants achieving TIR >80% between two groups | 26 weeks |
| Proportion of Participants Achieving TITR >60% | Proportion of participants achieving TITR (time in 70-140 mg/dL) >60% between two groups | 26 weeks |
| Number of TBR<70 Events | Numbers of events of CGM glucose <70 mg/dL lasting for at least 15 minutes between two groups | 26 weeks |
| Number of TBR <54 Events | Numbers of events of CGM glucose <54mg/dL lasting for at least 15 minutes between two groups | 26 weeks |
| Change in Total Daily Dose of Insulin (TDD, Units Per Day and U/Kg/Day) | Change in TDD between two groups | 26 weeks |
| Proportion Achieving Weight Loss ≥5% | Proportion of participants achieving weight loss ≥5% from baseline between two groups | 26 weeks |
| Proportion Achieving Weight Loss ≥10% | Proportion of participants achieving weight loss ≥10% from baseline between two groups | 26 weeks |
| Proportion of Achieving BMI <30 kg/m2 | Proportion of participants achieving BMI <30 kg/m2 between two groups | 26 weeks |
| Proportion of Achieving BMI <25 kg/m2 | Proportion of participants achieving BMI <25 kg/m2 between two groups | 26 weeks |
| Change in Systolic Blood Pressure (SBP) | change in SBP (mmHg) between two groups | 26 weeks |
| Change in Diastolic Blood Pressure (DBP) | change in DBP (mmHg) between two groups | 26 weeks |
| Change in Pulse Pressure | change in pulse pressure between two groups | 26 weeks |
| Change in Triglyceride/HDL Ratio | Change in triglyceride/HDL ratio between two groups | 26 weeks |
| Change in Brach D | Change in brachial arterial distensibility between two groups | 26 weeks |
| Change in Carotid Intima Media Thickness (cIMT) | Change in carotid intima media thickness (cIMT) between two groups | 26 weeks |
| Change in Femoral to Carotid Pulse Wave Velocity (m/s) | Change in femoral to carotid pulse wave velocity (m/s) between two groups | 26 weeks |
| Change in Urine Albumin to Creatinine Ratio (ACR) | Change in ACR between two groups | 26 weeks |
| Quality of Life (Diabetes Dependent QOL) | Change in QOL between two groups | 26 weeks |
| Change in CGM Metrics by Daytime vs Nighttime | Change in CGM metrics (TIR, TITR, mean glucose, TBR, TAR >180, SD, CV) by daytime (6 AM to <11 PM) and nighttime (11 PM to <6 AM) between two groups | 26 weeks |
| AID Setting Adjustment | Defined any adjustment in settings by provider or patient per person over the study period by two groups (number of adjustments (N) during trial) between two groups | 26 weeks |
| Change in Basal Insulin Per Day | Change in basal insulin per day (Total basal insulin including autobasal delivery, units per day and U/kg/day) between two groups | 26 weeks |
| Change in Total Boluses Per Day | Change in total boluses per day (frequency of boluses per day) between two groups | 26 weeks |
| Achievement of Primary Outcome and Key Secondary Outcomes by Types of AID Systems | Proportion of participants achieving primary outcome and key secondary glycemic outcomes by types of AID systems | 26 weeks |
| Change in Carbohydrate Intake Per Day (Grams/Day) | Change in Carbohydrate intake per day (grams/day) between two groups | 26 weeks |
| Change in Total Bolus Insulin Per Day | Change in total bolus insulin per day (units per day and U/Kg/day) between two groups | 26 weeks |
| Change in eGFR | Change in eGFR using CKD-EPI between two groups | 26 weeks |
| Change in Fib-4 Score | Change in Fib-4 score between two groups | 26 weeks |
| Change in HSI (Hepatic Steatosis Index) | Change in HSI (hepatic steatosis index) between two groups | 26 weeks |
| Change in MRI Measured Pulse Wave Velocity and Longitudinal Strain | Change in MRI measured pulse wave velocity and longitudinal strain between two groups | 26 weeks |
| Change in LDL-C | Change in LDL-C between two groups | 26 weeks |
| Change in TC | Change in TC between two groups | 26 weeks |
| Change in TG | Change in TG between two groups | 26 weeks |
| Change in HDL-C | Change in HDL-C between two groups | 26 weeks |
| Proportion With ACR <30 at 26 Weeks | Proportion of participants with ACR <30 at 26 weeks between two groups | 26 weeks |
| Proportion With Change in ACR From >30 to <30 | Proportion of participants with change in ACR from >30 to <30 between two groups | 26 weeks |
| Achievement of Primary Outcomes by Baseline BMI (BMI <35 vs >35) | Achievement of primary outcomes by baseline BMI (BMI <35 vs >35) | 26 weeks |
| Achievement of Primary Outcomes by Baseline A1c (A1c <7.5% vs >7.5%) | Achievement of primary outcomes by baseline A1c (A1c <7.5% vs >7.5%) | 26 weeks |
| West Des Moines |
| Iowa |
| 50265 |
| United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Harold Schnitzer Diabetes Health Center | Portland | Oregon | 97239 | United States |
Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| body mass index | Mean | Standard Deviation | kg/m2 |
|
| HbA1c | Mean | Standard Deviation | % |
|
| Diabetes Duration | Mean | Standard Deviation | years |
|
|
|
| Secondary | Change in HbA1c | HbA1c will be measured at a central laboratory and change in Hba1c from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | Posted | Least Squares Mean | Standard Error | percentage HbA1c | 26 weeks |
|
|
|
| Secondary | Change in Mean Glucose | Mean glucose (mg/dL) will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | Posted | Least Squares Mean | Standard Error | mg/dL | 26 weeks |
|
|
|
| Secondary | Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR) | Percent of time spent in tight glucose range (70-140 mg/dL) will be obtained by CGM and change in percent time in range from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | Posted | Least Squares Mean | Standard Error | percentage of time | 26 weeks |
|
|
|
| Secondary | Percent Time Spent in CGM-measured Glucose >180 mg/dL | Percent of time spent in glucose range >180 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | Posted | Least Squares Mean | Standard Error | percentage | 26 weeks |
|
|
|
| Secondary | Percent Time Spent in CGM-measured Glucose >250mg/dL | Percent of time spent in glucose range >250 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | Posted | Least Squares Mean | Standard Error | percentage | 26 weeks |
|
|
|
| Secondary | Percent Time Spent in CGM-measured Glucose <70mg/dL | Percent of time spent in glucose range <70 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | Posted | Least Squares Mean | Standard Error | percentage | 26 weeks |
|
|
|
| Secondary | Change in CGM Measured Glycemic Variability (Coefficient of Variation) | Glucose coefficient of variation (mg/dL) will be obtained by CGM and change in glucose CV from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis. | Posted | Least Squares Mean | Standard Error | percentage | 26 weeks |
|
|
|
| Secondary | Change in Weight | The change in kg of body weight from baseline to 26 weeks will be compared by randomization group using an ITT analysis. | Posted | Least Squares Mean | Standard Error | kg | 26 weeks |
|
|
|
| Secondary | Change in BMI (Kg/m2) | Change in body mass index (BMI) calculated as kg body weight per meter squared of height from baseline to 26 weeks will be compared by randomization group using an ITT analysis. | Posted | Least Squares Mean | Standard Error | kg/m2 | 26 weeks |
|
|
|
| Secondary | Severe Hypoglycemia | SH events in number of patients per group | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Other Pre-specified | Change in Patient Reported Quality of Life | Patient reported quality of life will be measured using a validated instrument (ADDQOL) and the change in score from baseline to 26 weeks will be compared by randomization group using an ITT analysis. | Not Posted | Jul 2026 | 26 weeks | Participants |
| Other Pre-specified | Proportion of Participants With HbA1c <7% | proportion (N, %) of participants achieving HbA1c <7% between two groups over 26 weeks | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion of Participants With HbA1c <7.5% | proportion (N, %) of participants achieving HbA1c <7.5% between two groups over 26 weeks | Not Posted | 26 weeks | Participants |
| Other Pre-specified | HbA1c Improvement | HbA1c improvement from baseline to 26 weeks between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | HbA1c Improvement of >0.4% From Baseline | proportion of participants with HbA1c improvement of >0.4% from baseline between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion of Participants Achieving TIR >70% | Proportion of participants achieving TIR >70% between two groups over 26 weeks | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion of Participants Achieving TITR >50% | Proportion of participants achieving TITR (time in 70-140 mg/dL) >50% between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion of Participants Achieving TIR >80% | Proportion of participants achieving TIR >80% between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion of Participants Achieving TITR >60% | Proportion of participants achieving TITR (time in 70-140 mg/dL) >60% between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Number of TBR<70 Events | Numbers of events of CGM glucose <70 mg/dL lasting for at least 15 minutes between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Number of TBR <54 Events | Numbers of events of CGM glucose <54mg/dL lasting for at least 15 minutes between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Total Daily Dose of Insulin (TDD, Units Per Day and U/Kg/Day) | Change in TDD between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion Achieving Weight Loss ≥5% | Proportion of participants achieving weight loss ≥5% from baseline between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion Achieving Weight Loss ≥10% | Proportion of participants achieving weight loss ≥10% from baseline between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion of Achieving BMI <30 kg/m2 | Proportion of participants achieving BMI <30 kg/m2 between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion of Achieving BMI <25 kg/m2 | Proportion of participants achieving BMI <25 kg/m2 between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Systolic Blood Pressure (SBP) | change in SBP (mmHg) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Diastolic Blood Pressure (DBP) | change in DBP (mmHg) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Pulse Pressure | change in pulse pressure between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Triglyceride/HDL Ratio | Change in triglyceride/HDL ratio between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Brach D | Change in brachial arterial distensibility between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Carotid Intima Media Thickness (cIMT) | Change in carotid intima media thickness (cIMT) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Femoral to Carotid Pulse Wave Velocity (m/s) | Change in femoral to carotid pulse wave velocity (m/s) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Urine Albumin to Creatinine Ratio (ACR) | Change in ACR between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Quality of Life (Diabetes Dependent QOL) | Change in QOL between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in CGM Metrics by Daytime vs Nighttime | Change in CGM metrics (TIR, TITR, mean glucose, TBR, TAR >180, SD, CV) by daytime (6 AM to <11 PM) and nighttime (11 PM to <6 AM) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | AID Setting Adjustment | Defined any adjustment in settings by provider or patient per person over the study period by two groups (number of adjustments (N) during trial) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Basal Insulin Per Day | Change in basal insulin per day (Total basal insulin including autobasal delivery, units per day and U/kg/day) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Total Boluses Per Day | Change in total boluses per day (frequency of boluses per day) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Achievement of Primary Outcome and Key Secondary Outcomes by Types of AID Systems | Proportion of participants achieving primary outcome and key secondary glycemic outcomes by types of AID systems | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Carbohydrate Intake Per Day (Grams/Day) | Change in Carbohydrate intake per day (grams/day) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Total Bolus Insulin Per Day | Change in total bolus insulin per day (units per day and U/Kg/day) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in eGFR | Change in eGFR using CKD-EPI between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in Fib-4 Score | Change in Fib-4 score between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in HSI (Hepatic Steatosis Index) | Change in HSI (hepatic steatosis index) between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in MRI Measured Pulse Wave Velocity and Longitudinal Strain | Change in MRI measured pulse wave velocity and longitudinal strain between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in LDL-C | Change in LDL-C between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in TC | Change in TC between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in TG | Change in TG between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Change in HDL-C | Change in HDL-C between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion With ACR <30 at 26 Weeks | Proportion of participants with ACR <30 at 26 weeks between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Proportion With Change in ACR From >30 to <30 | Proportion of participants with change in ACR from >30 to <30 between two groups | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Achievement of Primary Outcomes by Baseline BMI (BMI <35 vs >35) | Achievement of primary outcomes by baseline BMI (BMI <35 vs >35) | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Achievement of Primary Outcomes by Baseline A1c (A1c <7.5% vs >7.5%) | Achievement of primary outcomes by baseline A1c (A1c <7.5% vs >7.5%) | Not Posted | 26 weeks | Participants |
| 0 |
| 36 |
| 1 |
| 36 |
| 26 |
| 36 |
| EG001 | Control | Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy Placebo: Injection placebo up to 1 mg per week in addition to standard closed-loop therapy | 0 | 36 | 0 | 36 | 11 | 36 |
|
|
| Upper respitory infectin | Infections and infestations | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |