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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

NCTNCT01680653 (opens ClinicalTrials.gov in a new tab)Other id2012PG-T1D001Other idIRB 27428
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
57 participants (actual)
Sponsor
Stanford University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
May 2012
Primary completion
Sept 2012
Completion
Sept 2012
First posted
7 Sept 2012 (estimated)
Last update posted
5 Mar 2018
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013
  1. N/A

    Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

    NCT01680653

    May 2012 to Sept 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Mini-glucagonDrug
  • Remote monitoringDevice
  • CarbohydratesDietary supplement

Arms4

  • 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.

  • Other

    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.

  • Other

    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.

  • Other

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Duration of Nocturnal Hypoglycemia

    Time frame · 8 hours

    Registry description

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

Secondary outcomes(1)

  1. Duration of Glucose Readings <70 mg/dl

    Time frame · 8 Hours

    Registry description

    Number of minutes with glucose reading \< 70 mg/dL. Each camper had Remote Monitoring nights and Control nights.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 8 hours

Duration of Nocturnal Hypoglycemia

GroupValue (minutes)
Remote Monitoring12.5
Control15
Secondary and other outcome results(2)
Secondary outcomeMedian· 8 Hours

Duration of Glucose Readings <70 mg/dl

GroupValue (minutes)
Remote Monitoring30
Control (no Remote Monitoring)35
Other pre specified outcomeNumber· 8 hours at night

Prolonged Episodes of Hypoglycemic Events

GroupValue (events)
Remote Monitoring7
Control33

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Remote MonitoringAll participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights.–0 / 573 / 57
Control (no Remote Monitoring)All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights.–0 / 573 / 57

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultDeSalvo 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 7 Years up to 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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