Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

NCT ID: NCT01680653

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-09-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mini-Glucagon and Remote Monitoring

Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.

Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 "units" glucagon.

Group Type: EXPERIMENTAL

Mini-glucagon

Intervention Type: DRUG

Mini dose glucagon given for glucose \<70 mg/dl at a dose of 1unit/year of age

Remote monitoring

Intervention Type: DEVICE

Provides real-time continuous glucose monitoring

Carbohydrates and Remote Monitoring

Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.

Administration of carbohydrate per camp protocol to treat nocturnal hypoglycemia. Expected treatment is 15-45g.

Group Type: OTHER

Remote monitoring

Intervention Type: DEVICE

Provides real-time continuous glucose monitoring

Carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

16 grams of carbohydrate

Carbohydrates No Remote Monitoring

Subjects wear a continuous glucose monitor for their own use, but they are not remotely monitored.

If hypoglycemia occurs and is acknowledged through standard camp protocol it will be treated with standard camp protocol administration of carbohydrates. Expected treatment is 15g-45g.

Group Type: OTHER

Carbohydrates

Intervention Type: DIETARY_SUPPLEMENT

16 grams of carbohydrate

Mini-Glucagon and No Remote Monitoring

Subjects wear a continuous glucose monitor for their own use, but they are not remotely monitored.

If hypoglycemia occurs and is acknowledged through standard camp protocol it will be treated with mini-glucagon.

Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 "units" glucagon.

Group Type: OTHER

Mini-glucagon

Intervention Type: DRUG

Mini dose glucagon given for glucose \<70 mg/dl at a dose of 1unit/year of age

Interventions

Mini-glucagon

Mini dose glucagon given for glucose \<70 mg/dl at a dose of 1unit/year of age

Intervention Type: DRUG

Remote monitoring

Provides real-time continuous glucose monitoring

Intervention Type: DEVICE

Carbohydrates

16 grams of carbohydrate

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

glucagon

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Bruce A. Buckingham

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce Buckingham, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24168317 (View on PubMed)

Other Identifiers

IRB 27428

Identifier Type: OTHER

Identifier Source: secondary_id

2012PG-T1D001

Identifier Type: -

Identifier Source: org_study_id