Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

This study has been completed.
Sponsor:
Collaborators:
University of Virginia
DexCom, Inc.
Leona and Harry Helmsely Foundation
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University
ClinicalTrials.gov Identifier:
NCT01680653
First received: August 28, 2012
Last updated: March 31, 2015
Last verified: March 2015
  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: Mini-glucagon
Device: Remote monitoring
Dietary Supplement: Carbohydrates and remote monitoring
Dietary Supplement: Carbohydrates No remote monitoring

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.


Enrollment: 20
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 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: Mini-glucagon
Mini dose glucagon given for glucose <70 mg/dl at a dose of 1unit/year of age
Other Name: glucagon
Device: Remote monitoring
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.

Device: Remote monitoring
Provides real-time continuous glucose monitoring
Dietary Supplement: Carbohydrates and remote monitoring
16 grams of carbohydrate with remote monitoring
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.

Dietary Supplement: Carbohydrates No remote monitoring
Carbohydrates for hypoglycemia and no remote monitoring
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: Mini-glucagon
Mini dose glucagon given for glucose <70 mg/dl at a dose of 1unit/year of age
Other Name: glucagon

Detailed Description:

The study will include approximately 20 subjects with T1D per camp session. 10 will be linked to remote monitoring with the 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.

  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
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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: Bruce A. Buckingham, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01680653     History of Changes
Other Study ID Numbers: 2012PG-T1D001
Study First Received: August 28, 2012
Last Updated: March 31, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015