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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| Yale University | OTHER |
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"Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer program then tells an insulin pump to deliver the insulin. While such systems have been tested under a number of conditions, post-meal blood sugars are difficult to control. This study is designed to see if liraglutide, a glucagon like peptide receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1 diabetes while they are on a closed loop system.
Open-label, crossover study comparing the peak post-prandial glucose levels and the incremental post-prandial glucose area under the curve (AUC) during closed loop (CL) control alone and during CL control with liraglutide in an inpatient research setting. Data generated during outpatient baseline evaluation and liraglutide dose titration phases of the study will be compared to assess the short-term efficacy of this agent during open-loop continuous subcutaneous insulin infusion (CSII) pump treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed Loop Insulin Delivery | Experimental | Each participant recruited into the study will undergo two inpatient closed loop admissions. The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback. Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period. Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ePID closed loop system | Device | Insulin pump controlled by closed loop unit and algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Post-prandial Venous Glucose Levels | peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| the Incremental Meal-related Glucose Area Under Curve (AUC) | 5-hour post prandial period after breakfast, lunch, and dinner |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24-hour Glucose Levels | 24- hours | |
| Mean Time to Peak Post-meal Glucose Value | 5- hour postprandial period | |
| Mean Daytime Glucose Levels |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Sherr, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Each participant recruited into the study will undergo two inpatient closed loop admissions. The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback. Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period. Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Closed Loop Control |
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| ||||||||||||||||||
| Closed Loop Control + Liraglutide |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Subject Characteristics | Each participant recruited into the study will undergo two inpatient closed loop admissions. The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback. Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period. Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy. |
| 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 | Peak Post-prandial Venous Glucose Levels | peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide | Posted | Mean | Standard Error | mg/dL | 48 hours |
|
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Adverse events were recorded in categories with gastrointestinal disorders encompassing nausea, decreased appetite, constipation, bloating and/or diarrhea
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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 | Closed Loop Only | Each participant recruited into the study will undergo two inpatient closed loop admissions. The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal distress | Gastrointestinal disorders | nausea, decreased appetite, constipation, bloating, and/or diarrhea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Sherr | Yale University School of Medicine | 203-785-5831 | jennifer.sherr@yale.edu |
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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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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| liraglutide | Drug | Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist |
|
|
| 8a.m.-11p.m. |
| Incremental Glucagon Peak | 5 hours |
| AUC Plasma Glucagon During MMTT | 2 hours |
| Differences in Daily Insulin Requirements | 24 hours |
| Prandial Insulin Delivery During Closed Loop Therapy | Average of the 5-hour post prandial period for breakfast, lunch, dinner combined |
| Mean Nocturnal Glucose Levels | 11p.m.-6a.m. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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| Secondary | the Incremental Meal-related Glucose Area Under Curve (AUC) | Posted | Mean | Standard Deviation | mg*hr/dL | 5-hour post prandial period after breakfast, lunch, and dinner |
|
|
|
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| Other Pre-specified | Mean 24-hour Glucose Levels | Posted | Mean | Standard Deviation | mg/dL | 24- hours |
|
|
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| Other Pre-specified | Mean Time to Peak Post-meal Glucose Value | Posted | Mean | Standard Deviation | hours | 5- hour postprandial period |
|
|
|
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| Other Pre-specified | Mean Daytime Glucose Levels | Posted | Mean | Standard Deviation | mg/dL | 8a.m.-11p.m. |
|
|
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| Other Pre-specified | Incremental Glucagon Peak | Posted | Mean | Standard Deviation | pg/mL/min | 5 hours |
|
|
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| Other Pre-specified | AUC Plasma Glucagon During MMTT | Posted | Mean | Standard Deviation | pg*min/mL | 2 hours |
|
|
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| Other Pre-specified | Differences in Daily Insulin Requirements | Posted | Mean | Standard Deviation | units | 24 hours |
|
|
|
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| Other Pre-specified | Prandial Insulin Delivery During Closed Loop Therapy | Posted | Mean | Standard Deviation | units | Average of the 5-hour post prandial period for breakfast, lunch, dinner combined |
|
|
|
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| Other Pre-specified | Mean Nocturnal Glucose Levels | Posted | Mean | Standard Deviation | mg/dL | 11p.m.-6a.m. |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Closed Loop + Liraglutide | Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period. Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy. | 0 | 11 | 6 | 11 |
|
| headache | Nervous system disorders | headache |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |