Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

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.
    

Intervention name(s): Mini-glucagon; Remote monitoring; Carbohydrates
Intervention type(s): Drug; Device; Dietary Supplement
Intervention description(s): Mini dose glucagon given for glucose <70 mg/dl at a dose of 1unit/year of age; Provides real-time continuous glucose monitoring; 16 grams of carbohydrate
Other intervention name(s): glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care