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Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

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ClinicalTrials.gov Identifier: NCT01680653
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
University of Virginia
DexCom, Inc.
The Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Mini-glucagon Device: Remote monitoring Dietary Supplement: Carbohydrates Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study in Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
Study Start Date : May 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Glucagon
U.S. FDA Resources

Arm Intervention/treatment
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
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.

Dietary Supplement: Carbohydrates
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.

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



Primary Outcome Measures :
  1. Duration of Nocturnal Hypoglycemia [ Time Frame: 8 hours ]
    Number of minutes with glucose reading < 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.


Secondary Outcome Measures :
  1. Duration of Glucose Readings <70 mg/dl [ Time Frame: 8 Hours ]
    Number of minutes with glucose reading < 70 mg/dL. Each camper had Remote Monitoring nights and Control nights.


Other Outcome Measures:
  1. Prolonged Episodes of Hypoglycemic Events [ Time Frame: 8 hours at night ]
    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.



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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680653


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of Virginia
DexCom, Inc.
The Leona M. and Harry B. Helmsley Charitable Trust
Investigators
Principal Investigator: Bruce Buckingham, MD Stanford University

Publications of Results:
Responsible Party: Bruce A. Buckingham, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01680653     History of Changes
Other Study ID Numbers: 2012PG-T1D001
IRB 27428 ( Other Identifier: Stanford IRB )
First Posted: September 7, 2012    Key Record Dates
Results First Posted: March 5, 2018
Last Update Posted: March 5, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins