Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 7 - 21 |
| Updated: | 4/17/2018 |
| Start Date: | May 2012 |
| End Date: | September 2012 |
Pilot Study in Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
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.
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.
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 Computational/Communication
platform (DIAs), and 10 will wear the Dexcom CGM with the same threshold alarm setting as
those wearing the DiAs (70 mg/dl), 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 >0.7 units/kg/day 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 mg/dl. 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
camper's 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 mg/dl in a 1:1 ratio. All subjects less than 70
mg/dl 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.
will be linked to remote monitoring with the Diabetes Assistant Computational/Communication
platform (DIAs), and 10 will wear the Dexcom CGM with the same threshold alarm setting as
those wearing the DiAs (70 mg/dl), 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 >0.7 units/kg/day 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 mg/dl. 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
camper's 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 mg/dl in a 1:1 ratio. All subjects less than 70
mg/dl 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.
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one
year
- Age 7-21 years
- Attendee of Camp De Los Ninos or Conrad Chinnock
- Come to camp with a consent already signed after having talked to study staff about
the study, or at the onset of the camp meet with study staff and sign the consent
before the first night at camp.
- Using multiple daily insulin injections (Lantus) or on an insulin pump (any brand)
Exclusion Criteria:
- Cystic fibrosis
- Medications such as current use of oral steroids or other medications, which in the
judgment of the investigator would be a contraindication to participation in the
study.
- History of adhesive allergies which would interfere with sensor wear.
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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