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Recruiting NCT07459582

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

— Observational Glycogen Storage Disease Type IA Glycogen Storage Disease Type I Glycogen Storage Disease Type IB Glycogen Storage Disease Xi

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lactate Meter, Accu Chek.
Who it may be relevant to
Registry conditions: Glycogen Storage Disease Type IA, Glycogen Storage Disease Type I, Glycogen Storage Disease Type IB, Glycogen Storage Disease Xi. Basic parameters: up to 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Lactate Meter
    Hourly blood lactate levels
  • Device Accu Chek
    Hourly blood glucose levels

Primary outcome measures

  • 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 outcome measures (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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Patients with Glycogen storage disease unspecified
  • Patients not meeting inclusion criteria
  • Patients unable to provide consent
  • Patients who decline to be in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Connecticut Children's — Hartford

Identifiers

NCT: NCT07459582 · 25-061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗