Are Portable Lactate Monitoring Devices Accurate in Patients with Glycogen Storage Disease Ia When Compared to Blood Serum Lactates?

Last updated: February 20, 2025
Sponsor: Connecticut Children's Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Liver Disorders

Metabolic Disorders

Treatment

blood glucose meter; blood lactate meter

Clinical Study ID

NCT06843330
23-137
  • Ages < 60
  • All Genders

Study Summary

The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, compared to lab serum lactate in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, in a population of patients with glycogen storage disease type 1a.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with diagnosed/confirmed (by liver biopsy or genetic testing) GlycogenStorage Disease Type Ia (ICD 10 code: E74.01).

  • Connecticut Children's Emergency Department visit and/or admission to ConnecticutChildren's during time study is active

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

  • For adults: Ability to understand and the willingness to sign a written informedconsent

Exclusion

Exclusion Criteria:

  • Patients with Glycogen storage disease unspecified 74.00, or Ib

  • Patients not meeting inclusion criteria

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: blood glucose meter; blood lactate meter
Phase:
Study Start date:
March 10, 2025
Estimated Completion Date:
March 10, 2026

Study Description

The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type 1a.

Connect with a study center

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06107
    United States

    Active - Recruiting

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