Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Virginia
DexCom, Inc.
Leona and Harry Helmsely Foundation
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01680653
First received: August 28, 2012
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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 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.


Condition Intervention
Type 1 Diabetes
Drug: Glucagon
Device: University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study in Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Duration of nocturnal hypoglycemia [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
    minutes of glucose readings < 70 mg/dl


Secondary Outcome Measures:
  • Duration of Glucose readings <50 mg/dl [ Time Frame: 8 Hours ] [ Designated as safety issue: Yes ]
    minutes < 50 mg/dl on Dexcom sensor


Other Outcome Measures:
  • Need for repeat treatments of hypoglcyemia [ Time Frame: 8 Hours ] [ Designated as safety issue: No ]
    After treatment for hypoglycemia,how many additional treatments were required.


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: Glucagon Device: University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform
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.

Device: University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform
No Intervention: Carbohydrates 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 standard camp protocol administration of carbohydrates. Expected treatment is 15g-45g.

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.

Drug: Glucagon

  Eligibility

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680653

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of Virginia
DexCom, Inc.
Leona and Harry Helmsely Foundation
Investigators
Principal Investigator: Bruce Buckingham, MD Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01680653     History of Changes
Other Study ID Numbers: 2012PG-T1D001
Study First Received: August 28, 2012
Last Updated: September 4, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Glucagon-Like Peptide 1
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins

ClinicalTrials.gov processed this record on July 22, 2014