Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01680653
Status:
COMPLETED
Last Update Posted:
2018-03-05
First Post:
2012-08-28
Brief Title:
Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Pilot Study in Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The incidence of low blood sugar and hypoglycemic seizures at diabetes camp has been reduced thanks to overnight blood glucose level testing The timing of the overnight blood test is often arbitrary and it is unclear when the highest frequency of nocturnal hypoglycemic events at camp are occurring It is also unclear what the most appropriate treatment for nocturnal hypoglycemia is simple carbohydrates or mini-glucagon
In this study we will use Continuous Glucose Monitors CGMs that will send subject data securely to a remote computer located in the medical cottage at camp throughout the night Study staff will monitor the computer and will intervene on low blood sugar as it occurs in real time On half of the nights campers will receive mini-glucagon for low blood sugar and on the rest they will receive standard carbohydrate treatment
In this study we will use Continuous Glucose Monitors CGMs that will send subject data securely to a remote computer located in the medical cottage at camp throughout the night Study staff will monitor the computer and will intervene on low blood sugar as it occurs in real time On half of the nights campers will receive mini-glucagon for low blood sugar and on the rest they will receive standard carbohydrate treatment
Detailed Description:
The study will include approximately 20 subjects with Type 1 Diabetes per camp session 10 will be linked to remote monitoring with the Diabetes Assistant ComputationalCommunication platform DIAs and 10 will wear the Dexcom CGM with the same threshold alarm setting as those wearing the DiAs 70 mgdl but without remote monitoring
Study participants will be between the ages of 7-21 with type 1 diabetes This would allow for a counselor in training or a young counselor with a history of recent nocturnal hypoglycemia to be included It is these late adolescents and young adults who often have the most severe hypoglycemic events during a camp session We will preferentially recruit campers into the study who 1 have a history of nocturnal hypoglycemia requiring treatment within the last 2 months 2 have hypoglycemia unawareness confirmed with the Clark screening test 3 have an A1c of 8 while requiring 07 unitskgday of insulin and diabetes duration of 1year
At the beginning of camp a Dexcom G4 sensor will be inserted into each participating subject and after the initial calibration they will be calibrated with blood glucose levels in the morning and before bed each day as well as when the Dexcom sensor requests a calibration All insulin doses and treatment decisions at camp will be based on capillary blood glucose levels and they will not be based on sensor readings Each night 10 of the 20 campers will be randomly assigned to remote monitoring The randomization schedule will be computer generated prior to camp A hypoglycemia threshold will be set for 70 mgdl The Dexcom communicating with the DiAs will not sound a local alarm but an alarm will be generated at the remote monitoring Medical personnel on call at the remote monitoring station will come to the campers cabin and confirmatory capillary blood glucose CBG glucose will be obtained If the camper is 70 hypoglycemia treatment will be given we will not use predictive alarms or use the rate of change to determine treatment Treatment will be randomized to mini-glucagon or standard oral treatment if campers are 70 mgdl in a 11 ratio All subjects less than 70 mgdl will then be retested in 15 minutes with a CBG to confirm recovery from hypoglycemia
If a sensor should fail or be dislodged during camp it will be replaced If a sensor needs to be replaced more than 2 times a subject may be dropped and a different subject enrolled
There will be a designed medical staff person who will be monitoring subjects remotely each night A second staff person will be available to go to subjects cabins to provide treatment for hypoglycemia If a second event should occur at the same time a third staff person will be on call to attend the second camper
Study participants will be between the ages of 7-21 with type 1 diabetes This would allow for a counselor in training or a young counselor with a history of recent nocturnal hypoglycemia to be included It is these late adolescents and young adults who often have the most severe hypoglycemic events during a camp session We will preferentially recruit campers into the study who 1 have a history of nocturnal hypoglycemia requiring treatment within the last 2 months 2 have hypoglycemia unawareness confirmed with the Clark screening test 3 have an A1c of 8 while requiring 07 unitskgday of insulin and diabetes duration of 1year
At the beginning of camp a Dexcom G4 sensor will be inserted into each participating subject and after the initial calibration they will be calibrated with blood glucose levels in the morning and before bed each day as well as when the Dexcom sensor requests a calibration All insulin doses and treatment decisions at camp will be based on capillary blood glucose levels and they will not be based on sensor readings Each night 10 of the 20 campers will be randomly assigned to remote monitoring The randomization schedule will be computer generated prior to camp A hypoglycemia threshold will be set for 70 mgdl The Dexcom communicating with the DiAs will not sound a local alarm but an alarm will be generated at the remote monitoring Medical personnel on call at the remote monitoring station will come to the campers cabin and confirmatory capillary blood glucose CBG glucose will be obtained If the camper is 70 hypoglycemia treatment will be given we will not use predictive alarms or use the rate of change to determine treatment Treatment will be randomized to mini-glucagon or standard oral treatment if campers are 70 mgdl in a 11 ratio All subjects less than 70 mgdl will then be retested in 15 minutes with a CBG to confirm recovery from hypoglycemia
If a sensor should fail or be dislodged during camp it will be replaced If a sensor needs to be replaced more than 2 times a subject may be dropped and a different subject enrolled
There will be a designed medical staff person who will be monitoring subjects remotely each night A second staff person will be available to go to subjects cabins to provide treatment for hypoglycemia If a second event should occur at the same time a third staff person will be on call to attend the second camper
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 27428 | OTHER | Stanford IRB | None |