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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.
This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop insulin delivery system using a subcutaneous glucose sensor and an external insulin pump and comparing it to an open-loop delivery system during aerobic exercise. Subject participation will be for a maximum of 16 weeks including an outpatient study (up to 6 days) and two inpatient studies (one closed-loop; the other open-loop). The closed- and open-loop visit consists of approximately 67 hours over 4 days and 3 nights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed Loop (CL) Phase | Experimental | Closed Loop (CL) Phase |
|
| Standard of Care (OL) Phase | No Intervention | Standard of Care (OL) Phase or Open Loop Phase |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed Loop | Device | Insulin pump controlled by closed loop unit and algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose (PG) Response to Exercise | PG at start of exercise minus the subsequent PG nadir | Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min. |
| Incidence of Hypoglycemia Immediately Following Exercise | Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1. | Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min. |
| Incidence of Nocturnal Hypoglycemia Following Exercise | Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1. | Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Post-prandial Plasma Glucose (PG) | For each subject and study phase, the six peak PG following each of the six meals were determined. The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase. | Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy (urine pregnancy test) or lactation, if female.
Subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data.
Subject has a cardiac pacemaker or similar device that may be sensitive to radio frequency telemetry.
Subject using any of the following medications:
Subject has any of the following conditions
Subject has experienced two (2) or more severe hypoglycemic events -seizures/coma requiring assistance in the past six (6) months.
Subject has any other condition that in the investigator's opinion warrants exclusion from the study or precludes him/her from completing the protocol.
Subjects using dietary supplements within 14 days of study enrollment
Subject is currently enrolled in another study.
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Weinzimer, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Pediatrics Diabetes Research | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23757427 | Derived | Sherr JL, Cengiz E, Palerm CC, Clark B, Kurtz N, Roy A, Carria L, Cantwell M, Tamborlane WV, Weinzimer SA. Reduced hypoglycemia and increased time in target using closed-loop insulin delivery during nights with or without antecedent afternoon exercise in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2909-14. doi: 10.2337/dc13-0010. Epub 2013 Jun 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | First Standard of Care or Open Loop, Then CLosed Loop | All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study. |
| FG001 | First Closed Loop, Then Standard of Care or Open Loop | All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | First Closed Loop, Then Standard of Care or Open Loop | First Closed Loop, Then Standard of Care or Open Loop |
| BG001 | First Standard of Care or Open Loop, Then CLosed Loop | First Standard of Care or Open Loop, Then CLosed Loop |
| 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 | Plasma Glucose (PG) Response to Exercise | PG at start of exercise minus the subsequent PG nadir | All subjects were used for final analysis | Posted | Median | Inter-Quartile Range | mg/dL | Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min. |
|
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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 | Standard of Care (OL) Phase | Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harry Clark | Medtronic Diabetes | 818-576-5653 | bud.clark@medtronic.com |
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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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| Nadir Plasma Glucose (PG) Immediately Following Exercise | The PG nadir observed following the start of exercise | Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min. |
| Overnight Nadir Plasma Glucose (PG) | For each subject and study phase, the overnight nadir PG for each of two nights were determined. The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase. | Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases. |
| Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range. | For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals. | Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. |
| Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range. | For each subject and study phase, the percentage of the PG curve > 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals. | Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. |
| Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range. | For each subject and study phase, the percentage of the PG curve < 70 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals. | Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Closed Loop (CL) Phase |
Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study. |
|
|
|
| Primary | Incidence of Hypoglycemia Immediately Following Exercise | Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1. | All subjects were used for final analysis | Posted | Median | Inter-Quartile Range | hypoglycemic events | Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min. |
|
|
|
|
| Primary | Incidence of Nocturnal Hypoglycemia Following Exercise | Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1. | All subjects were used for final analysis | Posted | Median | Inter-Quartile Range | hypoglycemic events | Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases. |
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|
|
|
| Secondary | Peak Post-prandial Plasma Glucose (PG) | For each subject and study phase, the six peak PG following each of the six meals were determined. The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase. | All subjects were used for final analysis | Posted | Median | Inter-Quartile Range | mg/dL | Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min. |
|
|
|
|
| Secondary | Nadir Plasma Glucose (PG) Immediately Following Exercise | The PG nadir observed following the start of exercise | All subjects were used for final analysis | Posted | Median | Inter-Quartile Range | mg/dL | Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min. |
|
|
|
|
| Secondary | Overnight Nadir Plasma Glucose (PG) | For each subject and study phase, the overnight nadir PG for each of two nights were determined. The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase. | All subjects were used for final analysis | Posted | Median | Inter-Quartile Range | mg/dL | Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases. |
|
|
|
|
| Secondary | Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range. | For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals. | All subjects were used for final analysis | Posted | Median | Inter-Quartile Range | percentage of time | Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. |
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|
|
|
| Secondary | Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range. | For each subject and study phase, the percentage of the PG curve > 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals. | All subjects were used for final analysis | Posted | Median | Inter-Quartile Range | percentage of time | Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. |
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|
|
| Secondary | Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range. | For each subject and study phase, the percentage of the PG curve < 70 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals. | All subjects were used for final analysis | Posted | Median | Inter-Quartile Range | percentage of time | Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. |
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| Post-Hoc | Overall Incidence of Hypoglycemia | Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1. | All subjects were used for final analysis | Posted | Median | Inter-Quartile Range | hypoglycemic events | Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total. |
|
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|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Closed Loop (CL) Phase | Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study. | 0 | 13 | 1 | 13 |
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |