Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

Type 1 Diabetes Clinical Trial

Official title:

Pilot Study in Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680653
• Other study ID #: 2012PG-T1D001
• Secondary ID: IRB 27428
• Status: Completed
• Phase: N/A
• First received: August 28, 2012
• Last updated: January 30, 2018
• Start date: May 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Mini-glucagon
Mini dose glucagon given for glucose <70 mg/dl at a dose of 1unit/year of age

Device:
• Remote monitoring
Provides real-time continuous glucose monitoring

Dietary Supplement:
• Carbohydrates
16 grams of carbohydrate

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (4)

Lead Sponsor	Collaborator
Stanford University	DexCom, Inc., The Leona M. and Harry B. Helmsley Charitable Trust, University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prolonged Episodes of Hypoglycemic Events	Prolonged hypoglycemia is defined as glucose readings of either <70 mg/dL for greater than one hour on and off the device, <70 mg/dL for greater than 2 hours on and off the device, <50 mg/dL that lasted longer than 30 minutes on and off the device and readings of <50 mg/dL for longer than an hour, again for both the control and the subjects that were remotely monitored with the device. Each camper had Remote Monitoring nights and Control nights.	8 hours at night
Primary	Duration of Nocturnal Hypoglycemia	Number of minutes with glucose reading < 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.	8 hours
Secondary	Duration of Glucose Readings <70 mg/dl	Number of minutes with glucose reading < 70 mg/dL. Each camper had Remote Monitoring nights and Control nights.	8 Hours