Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

NCT01680653 | Completed Results

• 2 other identifiers: 2012PG-T1D001IRB 27428
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Duration of Nocturnal Hypoglycemia

  Number of minutes with glucose reading \< 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.

  8 hours

Secondary Outcomes (1)

• Duration of Glucose Readings <70 mg/dl

  8 Hours

Other Outcomes (1)

• Prolonged Episodes of Hypoglycemic Events

  8 hours at night

Study Arms (4)

Mini-Glucagon and Remote Monitoring

EXPERIMENTAL

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; Device: Remote monitoring

Carbohydrates and Remote Monitoring

OTHER

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; Dietary Supplement: Carbohydrates

Carbohydrates No Remote Monitoring

OTHER

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

Mini-Glucagon and No Remote Monitoring

OTHER

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

Interventions

Mini-glucagon DRUG

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

Also known as: glucagon

Mini-Glucagon and No Remote Monitoring; Mini-Glucagon and Remote Monitoring

Remote monitoring DEVICE

Provides real-time continuous glucose monitoring

Carbohydrates and Remote Monitoring; Mini-Glucagon and Remote Monitoring

Carbohydrates DIETARY_SUPPLEMENT

16 grams of carbohydrate

Carbohydrates No Remote Monitoring; Carbohydrates and Remote Monitoring

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• University of Virginia: collaborator
• DexCom, Inc.: collaborator
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 24168317 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucagon; Carbohydrates

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Limitations revolved around sensor failure. There was one subject removed because of improper use of the device (turning it off at improper times and failing to calibrate as instructed).

Results Point of Contact

• Title: Dr. Bruce Buckingham
• Organization: Stanford University

bbendo@stanford.edu

650-725-6549

Study Officials

• Bruce Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 7, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 5, 2018
• Results First Posted: March 5, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)