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| ID | Type | Description | Link |
|---|---|---|---|
| 21856 | Other Grant/Funding Number | University of Minnesota - CTSI |
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| Name | Class |
|---|---|
| Medtronic MiniMed, Inc. | INDUSTRY |
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The purpose of this study is to determine the effectiveness of closed loop insulin pump therapy to control blood sugar following total pancreatectomy and islet auto-transplantation (TPIAT).
OBJECTIVES AND HYPOTHESES The main objective of this study is to determine if a closed loop insulin system can successfully achieve tighter blood sugar control than the current multiple daily injection regimen. The investigators hypothesize that the average blood glucose will be lower in the closed loop group than the control group, there will be less glucose variability in the closed loop group than the control group, and there will be less total time spent in hyperglycemia and hypoglycemia in the closed loop group than in the control group. The investigators also will investigate insulin requirements and islet function in the first 6 months post-transplant in the closed loop group The investigators hypothesize that the insulin requirements will be lower and the C-peptide levels higher in the closed loop group than in the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period. | |
| Closed Loop Insulin | Experimental | Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed Loop Insulin | Device | The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms). |
| Measure | Description | Time Frame |
|---|---|---|
| Study Period: Average Serum BG | Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups. | 3 days of investigation period |
| Study Period: Serum BG Standard Deviation | Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient. | 3 days of investigation period |
| Measure | Description | Time Frame |
|---|---|---|
| Study Period: Continuous Glucose Monitor (CGM) BG Average | Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period | continuously over the 72 hour investigational period |
| Study Period: Continuous Glucose Monitor Standard Deviation of BG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melena Bellin, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26588810 | Derived | Forlenza GP, Nathan BM, Moran AM, Dunn TB, Beilman GJ, Pruett TL, Bellin MD. Successful Application of Closed-Loop Artificial Pancreas Therapy After Islet Autotransplantation. Am J Transplant. 2016 Feb;16(2):527-34. doi: 10.1111/ajt.13539. Epub 2015 Nov 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period. |
| FG001 | Closed Loop Insulin | Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period. |
| BG001 | Closed Loop Insulin |
| 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 | Study Period: Average Serum BG | Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups. | Posted | Mean | Standard Deviation | mg/dL | 3 days of investigation period |
|
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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 | Control | Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Hypoglycemia | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melena Bellin | University of Minnesota | 612-624-5409 | bell0130@umn.edu |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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|
measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings. |
| continuous over the 72 hour investigation period |
| Study Period: Percent Time BG in Range 70-140 mg/dL | Additional measure of glycemic variability, as reflected by CGM measures, % time in the range of 70-140 on CGM | continuous over the 72 hour investigation period |
| Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL | Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL. | continuous over the 72 hour investigation period |
| Study Period: % of Time CGM BG <70 mg/dL | continuous over the 72 hour investigation period |
| Study Period: CGM AUC With Glucose> 140 mg/dL | continuous over the 72 hour investigation period |
| Study Period: % of Time CGM BG > 140 mg/dL | continuous over the 72 hour investigation period |
| Study Period: Morning C-peptide | A single C-peptide measurement collected daily x 3 days, collected at random (meaning not in a fasting state) each morning. Expressed as average for each patient. | Average of 3 day study period |
| Study Period: Daily Insulin Needs | Calculated as total daily dose of insulin. | Average of 3 day study period |
| Day 14 Follow-Up: Average Serum BG | Day 14 Follow-Up |
| Day 14 Follow-Up: C-Peptide | Day 14 Follow-Up: |
| Day 28 Follow-Up: Average Serum BG | Day 28 Follow-Up |
| Day 28 Follow-Up: C-Peptide | Day 28 Follow-Up |
Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight at Transplant | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) at Transplant | Mean | Standard Deviation | kg/m2 |
|
| hemoglobin A1c (A1c) | Mean | Standard Deviation | % |
|
| Fasting Blood Glucose (BG) | Mean | Standard Deviation | mg/dL |
|
| Fasting C-Peptide | Mean | Standard Deviation | ng/mL |
|
| Peak Mixed Meal Tolerance Test (MMTT) C-peptide | Mean | Standard Deviation | ng/mL |
|
| Islet Yield | Mean | Standard Deviation | IEq/kg |
|
| Days on drip | Mean | Standard Deviation | days |
|
| Etiology of Chronic Pancreatitis (CP) | Number | participants |
|
|
|
|
| Primary | Study Period: Serum BG Standard Deviation | Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient. | Posted | Mean | Standard Deviation | mg/dL | 3 days of investigation period |
|
|
|
|
| Secondary | Study Period: Continuous Glucose Monitor (CGM) BG Average | Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period | Posted | Mean | Standard Deviation | mg/dL | continuously over the 72 hour investigational period |
|
|
|
|
| Secondary | Study Period: Continuous Glucose Monitor Standard Deviation of BG | measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings. | Posted | Mean | Standard Deviation | mg/dL | continuous over the 72 hour investigation period |
|
|
|
|
| Secondary | Study Period: Percent Time BG in Range 70-140 mg/dL | Additional measure of glycemic variability, as reflected by CGM measures, % time in the range of 70-140 on CGM | Posted | Mean | 95% Confidence Interval | % of time | continuous over the 72 hour investigation period |
|
|
|
|
| Secondary | Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL | Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL. | Posted | Mean | Standard Deviation | min*mg/dL/day | continuous over the 72 hour investigation period |
|
|
|
|
| Secondary | Study Period: % of Time CGM BG <70 mg/dL | Posted | Mean | 95% Confidence Interval | % of time | continuous over the 72 hour investigation period |
|
|
|
|
| Secondary | Study Period: CGM AUC With Glucose> 140 mg/dL | Posted | Mean | Standard Deviation | min*mg/dL/day | continuous over the 72 hour investigation period |
|
|
|
|
| Secondary | Study Period: % of Time CGM BG > 140 mg/dL | Posted | Mean | 95% Confidence Interval | % of time | continuous over the 72 hour investigation period |
|
|
|
|
| Secondary | Study Period: Morning C-peptide | A single C-peptide measurement collected daily x 3 days, collected at random (meaning not in a fasting state) each morning. Expressed as average for each patient. | Posted | Mean | Standard Deviation | ng/mL | Average of 3 day study period |
|
|
|
|
| Secondary | Study Period: Daily Insulin Needs | Calculated as total daily dose of insulin. | Posted | Mean | Standard Deviation | U/kg/day | Average of 3 day study period |
|
|
|
|
| Secondary | Day 14 Follow-Up: Average Serum BG | Posted | Mean | Standard Deviation | mg/dL | Day 14 Follow-Up |
|
|
|
|
| Secondary | Day 14 Follow-Up: C-Peptide | Posted | Mean | Standard Deviation | ng/mL | Day 14 Follow-Up: |
|
|
|
|
| Secondary | Day 28 Follow-Up: Average Serum BG | Posted | Mean | Standard Deviation | mg/dL | Day 28 Follow-Up |
|
|
|
|
| Secondary | Day 28 Follow-Up: C-Peptide | Posted | Mean | Standard Deviation | ng/mL | Day 28 Follow-Up |
|
|
|
|
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | Closed Loop Insulin | Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms). | 0 | 7 | 3 | 7 |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |