Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 60
SponsorConnecticut Children's Medical Center

About this trial

The goal of this study is to determine if the Lactate Plus meter is accurate compared to lab lactate levels, and to determine if the Accu chek guide glucometer is accurate compared to lab serum glucose levels in patients with Glycogen Storage Disease Types Ia, Ib and XI.

To determine this, patient's will have a one-time planned admission to Connecticut Children's for approximately 8 hours and receive hourly blood draws as well as finger-sticks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with diagnosed/confirmed (by liver biopsy or genetic testing) Glycogen Storage Disease Type Ia/Ib (ICD 10 code: E74.01) or XI (74.09).

For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document

For adolescents: assent to participate

For adults: Ability to understand and the willingness to sign a written informed consent

Disqualifiers

Patients with Glycogen storage disease unspecified

Patients not meeting inclusion criteria

Patients unable to provide consent

Patients who decline to be in the study

Trial population

Patients birth to age 60 years with diagnosed Glycogen Storage Disease Type Ia/Ib or XI.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Lactate Meter

    Other intervention

    Hourly blood lactate levels

  • Accu Chek

    Device

    Hourly blood glucose levels

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

To determine if the lactate Plus meter (both capillary and serum sample) readings are within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type Ia/Ib/XI

Time frame
Hourly x 8 hours

Secondary outcomes

1

To determine if the Accu-Chek Guide glucometer (capillary sample) readings are within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type Ia/Ib/XI

Time frame
Hourly x 8 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Connecticut Children's Medical Center

Lead sponsor

Global Center for Glycogen Storage Disease held at the Jewish Community Foundation

Collaborator