Ignite Creation Date:
2024-05-06 @ 2:27 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02047643
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2014-01-17
Brief Title:
Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes Outpatient Exercise Protocol
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes Outpatient Exercise Protocol
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of exercise-associated hypoglycemia low blood sugar in patients with type 1 diabetes T1D However since patients with T1D often do not make exercise-related adjustments to their insulin regimen our group has developed an algorithm to initiate pump suspension in a user-independent manner upon projecting exercise-associated hypoglycemia The current study seeks to test the efficacy of this algorithm by asking users to participate in a sports camp while wearing an insulin pump continuous glucose monitor and accelerometerheart rate monitor to detect exercise which will communicate electronically to a pump shutoff algorithm On one of the days the algorithm will be used while on the other day their normal insulin rate will continue for comparative purposes
The investigators hypothesize that the use of an accelerometer-augmented computer algorithm for insulin pump suspension during exercise will result in significantly fewer episodes of hypoglycemia both during exercise and in post-exercise monitoring than in exercise without a pump suspension algorithm
The investigators hypothesize that the use of an accelerometer-augmented computer algorithm for insulin pump suspension during exercise will result in significantly fewer episodes of hypoglycemia both during exercise and in post-exercise monitoring than in exercise without a pump suspension algorithm
Detailed Description:
Regular aerobic exercise confers a plethora of health benefits to all individuals and is considered an essential component of the management of type 1 diabetes T1D 1 However in contrast to non-diabetic subjects - in whom the increased muscle energy requirement during exercise leads to suppression of endogenous insulin secretion - patients with T1D are dependent upon exogenous insulin and are thus at risk for exercise-associated hypoglycemia 1 Exercise-associated hypoglycemia is the most frequently reported adverse event related to exercise in diabetes 2 and hypoglycemia can occur during exercise or several hours afterwards 34 Although previous research has shown that pre-meal dose reduction of subcutaneous insulin can be effective at decreasing the incidence of exercise-associated hypoglycemia 5 patients with T1D often do not perform such adjustments 67
In contrast to subcutaneous insulin injections which are reliant upon the patient or caretaker to determine dosage the insulin pump provides a unique opportunity to avoid hypoglycemia via user-independent computer-based algorithms for determining insulin delivery Previous research conducted here at Stanford has demonstrated that algorithms based on continuous glucose monitor CGM data can prevent hypoglycemia in the sedentary setting by inducing insulin pump suspension 8-10 In addition a study of children and adolescents conducted at Stanford as a center in the DirecNet group demonstrated that suspending an insulin pump at the beginning of a period of moderate aerobic exercise reduces the risk of hypoglycemia during that exercise period and subsequently overnight 11 Thus by utilizing exercise-detecting accelerometers and an algorithm to initiate pump suspension during exercise it is likely possible that people with diabetes could avoid exercise-associated hypoglycemia even if they failed to manually alter their pump settings However to date no published studies have utilized accelerometer-derived data in an insulin pump suspension algorithm during exercise
Accelerometers are light-weight motion-sensing devices that can be worn to provide information about the intensity and duration of physical activity 12 They are small inexpensive and could easily be incorporated into current sensors and patch pumps They can also be used independently or combined with a heart rate monitor HRM 13 although most commercially available HRMs currently require a chest strap that can be uncomfortable to wear Previous studies evaluating the effect of physical activity on insulin sensitivity have utilized accelerometers worn on a belt at the small of the back the right side of the trunk in the mid-axillary line or the left side of the chest with and without HRMs for activity recognition during subjects everyday lives These data were used to classify activity as sedentary light moderate or vigorous based on acceleration signal counts measured over one-minute intervals 13-17 One study investigated four different accelerometers in a clinical research setting and found each to be very accurate in assessing the intensity of physical activity regardless of subjects body habitus 18 Thus these devices can provide a reliable means by which the onset duration and intensity of exercise can be recognized and reported in real-time to the other components of an artificial pancreas When combined with CGM and insulin delivery data this exercise information is a valuable tool in designing an algorithm to decrease or stop insulin delivery in order to decrease the risk of exercise-associated hypoglycemia
In the first phase of this study in press 22 subjects with type 1 diabetes went about their everyday lives while wearing an insulin pump CGM and accelerometerheart rate monitor After the monitoring period the devices were downloaded and the data were used to augment an existing predictive low glucose suspend PLGS algorithm to incorporate activity In a computer simulator the PLGS algorithm reduced hypoglycemia by 64 compared to 73 and 76 reductions for the accelerometer-augmented and HRM-augmented algorithms respectively
In the next phase of this study we seek to test the newly developed algorithm in a real-life setting in the form of a structured sports soccer camp to further see if modifications to the algorithm are required
In contrast to subcutaneous insulin injections which are reliant upon the patient or caretaker to determine dosage the insulin pump provides a unique opportunity to avoid hypoglycemia via user-independent computer-based algorithms for determining insulin delivery Previous research conducted here at Stanford has demonstrated that algorithms based on continuous glucose monitor CGM data can prevent hypoglycemia in the sedentary setting by inducing insulin pump suspension 8-10 In addition a study of children and adolescents conducted at Stanford as a center in the DirecNet group demonstrated that suspending an insulin pump at the beginning of a period of moderate aerobic exercise reduces the risk of hypoglycemia during that exercise period and subsequently overnight 11 Thus by utilizing exercise-detecting accelerometers and an algorithm to initiate pump suspension during exercise it is likely possible that people with diabetes could avoid exercise-associated hypoglycemia even if they failed to manually alter their pump settings However to date no published studies have utilized accelerometer-derived data in an insulin pump suspension algorithm during exercise
Accelerometers are light-weight motion-sensing devices that can be worn to provide information about the intensity and duration of physical activity 12 They are small inexpensive and could easily be incorporated into current sensors and patch pumps They can also be used independently or combined with a heart rate monitor HRM 13 although most commercially available HRMs currently require a chest strap that can be uncomfortable to wear Previous studies evaluating the effect of physical activity on insulin sensitivity have utilized accelerometers worn on a belt at the small of the back the right side of the trunk in the mid-axillary line or the left side of the chest with and without HRMs for activity recognition during subjects everyday lives These data were used to classify activity as sedentary light moderate or vigorous based on acceleration signal counts measured over one-minute intervals 13-17 One study investigated four different accelerometers in a clinical research setting and found each to be very accurate in assessing the intensity of physical activity regardless of subjects body habitus 18 Thus these devices can provide a reliable means by which the onset duration and intensity of exercise can be recognized and reported in real-time to the other components of an artificial pancreas When combined with CGM and insulin delivery data this exercise information is a valuable tool in designing an algorithm to decrease or stop insulin delivery in order to decrease the risk of exercise-associated hypoglycemia
In the first phase of this study in press 22 subjects with type 1 diabetes went about their everyday lives while wearing an insulin pump CGM and accelerometerheart rate monitor After the monitoring period the devices were downloaded and the data were used to augment an existing predictive low glucose suspend PLGS algorithm to incorporate activity In a computer simulator the PLGS algorithm reduced hypoglycemia by 64 compared to 73 and 76 reductions for the accelerometer-augmented and HRM-augmented algorithms respectively
In the next phase of this study we seek to test the newly developed algorithm in a real-life setting in the form of a structured sports soccer camp to further see if modifications to the algorithm are required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None