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Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

NCT01680653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2018-03-05

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER

  • DexCom, Inc.

    collaborator INDUSTRY

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Stanford University

    lead OTHER

Principal Investigators

  • Bruce Buckingham, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01680653 on ClinicalTrials.gov