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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DK121942-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Fat High Protein (HFHP) Meal- extended then standard insulin bolus arm | Experimental | Subjects will receive extended meal bolus for breakfast on the first day and standard meal bolus on the second day of the study. |
|
| High Fat High Protein (HFHP) Meal- standard then extended insulin bolus arm | Experimental | Subjects will receive standard meal bolus for breakfast on the first day and extended meal bolus on the second day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem t:slim X2 insulin pump: Extended bolus of insulin then standard bolus of insulin | Device | For a standardized HFHP breakfast, participants will receive an extended meal bolus of insulin on the first morning and a standard meal bolus of insulin on the second morning of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Area Under Curve [AUC] | Area under the curve between glucose trace and starting glucose (mg/dL* min) | 0 to 5 hours post-meal onset |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Between 70-180 mg/dL | Percentage of time spent between 70-180 mg/dl based on Continuous Glucose Monitor (CGM) values | 0 to 5 hours post-meal onset |
| Percentage of Time in Hypoglycemic Range (Defined as < 70 mg/dL) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Laya Ekhlaspour, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 | United States |
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A total of 30 participants were enrolled. Three participants were screen failures. Of the remaining 27 eligible participants, 22 were randomized and 5 withdrew or were withdrawn prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Fat High Protein (HFHP) Meal With Standard Insulin Bolus Then Extended Bolus | Subjects will receive standard meal bolus for the HFHP breakfast first. On a separate morning, subjects will receive an extended meal bolus for the HFHP breakfast. |
| FG001 | High Fat High Protein (HFHP) Meal With Extended Insulin Bolus Then Standard Bolus | Subjects will receive extended meal bolus for the HFHP breakfast first. On a separate morning, subjects will receive a standard meal bolus for the HFHP breakfast. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Fat High Protein (HFHP) Meal With Standard Insulin Bolus Then Extended Bolus | Subjects will receive standard meal bolus for the HFHP breakfast first. On a separate morning, subjects will receive an extended meal bolus for the HFHP breakfast. |
| BG001 | High Fat High Protein (HFHP) Meal With Extended Insulin Bolus Then Standard Bolus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glucose Area Under Curve [AUC] | Area under the curve between glucose trace and starting glucose (mg/dL* min) | Posted | Mean | Standard Deviation | (mg/dL* min) | 0 to 5 hours post-meal onset |
|
Throughout the 5 hour monitoring period post-meal onset
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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 | High Fat High Protein (HFHP) Meal With Standard Insulin Bolus | Subjects will receive standard meal bolus for the HFHP breakfast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emesis | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laya Ekhlaspour, MD | UCSF | 415-514-8531 | laya.ekhlaspour@ucsf.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 | Mar 13, 2026 | Mar 13, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Adult Participant | Feb 6, 2025 | Mar 12, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Minor Parental | Feb 6, 2025 | Mar 12, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent | Feb 6, 2025 | Mar 12, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will be randomly assigned (1:1) in blocks of two to the order in which they receive the two premeal insulin boluses: extended followed by standard bolus or a standard followed by extended bolus.
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|
| Tandem t:slim X2 insulin pump: Standard bolus of insulin then extended bolus of insulin | Device | For a standardized HFHP breakfast, participants will receive a standard bolus of insulin on the first morning and an extended bolus of insulin on the second morning of the study. |
|
Percentage of time spent with blood sugar less than 70 mg/dL based on Continuous Glucose Monitor (CGM) values
| 0 to 5 hours post-meal onset |
| Average Glucose | Average glucose value based on Continuous Glucose Monitor (CGM) values | 0 to 5 hours post-meal onset |
| Percentage of Time in Hyperglycemic Range (Defined as ≥180 mg/dL); | Percentage of time spent with blood sugar higher than 180 mg/dL based on Continuous Glucose Monitor (CGM) values | 0 to 5 hours post-meal onset |
| Insulin Dosage | Total insulin received during 5 hrs ( manual bolus as well as automated) | 0 to 5 hours post-meal onset |
| Time to Target (110mg/dL) | Time spent till blood glucose returns to 110mg/dL | 0 to 5 hours post-meal onset |
| Time to Baseline | Time spent till blood glucose returns to baseline | 0 to 5 hours post-meal onset |
| Time to Peak Glucose | Time spent till blood glucose reaches the maximum value after meal | 0 to 5 hours post-meal onset |
| Change in Glucose | The difference between baseline to max glucose value | 0 to 5 hours post-meal onset |
| Peak Glucose Concentration | Max blood glucose | 0 to 5 hours post-meal onset |
| Percentage of Time Between 70-140 mg/dL | Percent of glucose readings from CGM system between 70-140 mg/dL per unit of time | 0 to 5 hours post-meal onset |
Subjects will receive extended meal bolus for the HFHP breakfast first. On a separate morning, subjects will receive a standard meal bolus for the HFHP breakfast. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Time Between 70-180 mg/dL | Percentage of time spent between 70-180 mg/dl based on Continuous Glucose Monitor (CGM) values | Posted | Mean | Standard Deviation | Percentage of time | 0 to 5 hours post-meal onset |
|
|
|
| Secondary | Percentage of Time in Hypoglycemic Range (Defined as < 70 mg/dL) | Percentage of time spent with blood sugar less than 70 mg/dL based on Continuous Glucose Monitor (CGM) values | Posted | Mean | Standard Deviation | Percentage of time | 0 to 5 hours post-meal onset |
|
|
|
| Secondary | Average Glucose | Average glucose value based on Continuous Glucose Monitor (CGM) values | Posted | Mean | Standard Deviation | mg/dL | 0 to 5 hours post-meal onset |
|
|
|
| Secondary | Percentage of Time in Hyperglycemic Range (Defined as ≥180 mg/dL); | Percentage of time spent with blood sugar higher than 180 mg/dL based on Continuous Glucose Monitor (CGM) values | Posted | Mean | Standard Deviation | Percentage of time | 0 to 5 hours post-meal onset |
|
|
|
| Secondary | Insulin Dosage | Total insulin received during 5 hrs ( manual bolus as well as automated) | Posted | Mean | Standard Deviation | Units | 0 to 5 hours post-meal onset |
|
|
|
| Secondary | Time to Target (110mg/dL) | Time spent till blood glucose returns to 110mg/dL | Posted | Mean | Standard Deviation | Minutes | 0 to 5 hours post-meal onset |
|
|
|
| Secondary | Time to Baseline | Time spent till blood glucose returns to baseline | Posted | Mean | Standard Deviation | Minutes | 0 to 5 hours post-meal onset |
|
|
|
| Secondary | Time to Peak Glucose | Time spent till blood glucose reaches the maximum value after meal | Posted | Mean | Standard Deviation | Minutes | 0 to 5 hours post-meal onset |
|
|
|
| Secondary | Change in Glucose | The difference between baseline to max glucose value | Posted | Mean | Standard Deviation | mg/dL | 0 to 5 hours post-meal onset |
|
|
|
| Secondary | Peak Glucose Concentration | Max blood glucose | Posted | Mean | Standard Deviation | mg/dL | 0 to 5 hours post-meal onset |
|
|
|
| Secondary | Percentage of Time Between 70-140 mg/dL | Percent of glucose readings from CGM system between 70-140 mg/dL per unit of time | Posted | Mean | Standard Deviation | Percentage of time | 0 to 5 hours post-meal onset |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 1 |
| 22 |
| EG001 | High Fat High Protein (HFHP) Meal With Extended Insulin Bolus | Subjects will receive extended meal bolus for the HFHP breakfast. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |