An interventional study of Closed Loop in Type 1 Diabetes Mellitus, sponsored by Medtronic Diabetes. Completed at 1 site in United States. Open to participants aged 12 Years to 30 Years. Per ClinicalTrials.gov, last updated 2017-12-12.
Sponsored by Medtronic Diabetes · Not applicable, Interventional, and Other
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 13 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Medtronic Diabetes is the lead sponsor of 61 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 21 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject using any of the following medications:
Subject has any of the following conditions
Closed Loop (CL) Phase
Device: Closed Loop
Standard of Care (OL) Phase or Open Loop Phase
Insulin pump controlled by closed loop unit and algorithm
Plasma Glucose (PG) Response to Exercise
PG at start of exercise minus the subsequent PG nadir
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
Time frame: 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.
Nadir Plasma Glucose (PG) Immediately Following Exercise
The PG nadir observed following the start of exercise
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
| Milestone | First Standard of Care or Open Loop, Then CLosed Loop | First Closed Loop, Then Standard of Care or Open Loop |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 6 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
PG at start of exercise minus the subsequent PG nadir
| mg/dL | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| Plasma Glucose (PG) Response to Exercise | 75 (48 to 100) | 90.5 (59.75 to 105) |
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.
| hypoglycemic events | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| Incidence of Hypoglycemia Immediately Following Exercise | 0 (0 to 0) | 0 (0 to 0) |
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.
| hypoglycemic events | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| Incidence of Nocturnal Hypoglycemia Following Exercise | 0 (0 to 1) | 0 (0 to 0) |
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.
| mg/dL | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| Peak Post-prandial Plasma Glucose (PG) | 188 (162.5 to 227.875) | 229.75 (207.875 to 242.375) |
The PG nadir observed following the start of exercise
| mg/dL | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| Nadir Plasma Glucose (PG) Immediately Following Exercise | 80.5 (65.75 to 120.75) | 70.5 (66.75 to 80.5) |
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.
| mg/dL | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| Overnight Nadir Plasma Glucose (PG) | 74.5 (61.375 to 109.625) | 93.5 (84.5 to 97.25) |
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.
| percentage of time | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range. | 74.1 (66.2 to 81.4) | 79.8 (73.3 to 83.8) |
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.
| percentage of time | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range. | 19.7 (6.7 to 32.6) | 17.3 (15.6 to 21.8) |
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.
| percentage of time | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range. | 6 (0.1 to 10) | 1.1 (0.5 to 2.9) |
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.
| hypoglycemic events | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| Overall Incidence of Hypoglycemia | 3 (0 to 5.5) | 1 (0.75 to 1) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care (OL) Phase | — | 0/13 (0%) | 0/13 (0%) |
| Closed Loop (CL) Phase | — | 0/13 (0%) | 1/13 (7.7%) |
| Event | Standard of Care (OL) Phase | Closed Loop (CL) Phase |
|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 0/13 | 1/13 |
| PruritusSkin and subcutaneous tissue disorders | 0/13 | 1/13 |
| Age, Categorical(Participants) | First Closed Loop, Then Standard of Care or Open Loop | First Standard of Care or Open Loop, Then CLosed Loop | Total |
|---|---|---|---|
| <=18 years | 7 | 4 | 11 |
| Between 18 and 65 years | 0 | 2 | 2 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | First Closed Loop, Then Standard of Care or Open Loop | First Standard of Care or Open Loop, Then CLosed Loop | Total |
|---|---|---|---|
| Mean | 14.4 ± 2.1 | 17.7 ± 4.7 | 15.9 ± 3.8 |
| Sex: Female, Male(Participants) | First Closed Loop, Then Standard of Care or Open Loop | First Standard of Care or Open Loop, Then CLosed Loop | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 4 | 3 | 7 |
Plan to share: No
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Medtronic Diabetes