Clinical trial NCT01680653: Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
Official title: Pilot Study in Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: DexCom, Inc.
name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2012-09-07
Enrollment: 57
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Nocturnal Hypoglycemia
timeFrame: 8 hours
Secondary outcomes:
measure: Duration of Glucose Readings <70 mg/dl
timeFrame: 8 Hours
Other outcomes:
measure: Prolonged Episodes of Hypoglycemic Events
timeFrame: 8 hours at night
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Bruce Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeSalvo DJ, Keith-Hynes P, Peyser T, Place J, Caswell K, Wilson DM, Harris B, Clinton P, Kovatchev B, Buckingham BA. Remote glucose monitoring in camp setting reduces the risk of prolonged nocturnal hypoglycemia. Diabetes Technol Ther. 2014 Jan;16(1):1-7. doi: 10.1089/dia.2013.0139. Epub 2013 Oct 29.