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NCT Number: NCT07459582

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

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.

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Key information

Conditions

Glycogen Storage Disease Type IA Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fanconi Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Glycogen Storage Disease Glycogen Storage Disease IB Glycogen Storage Disease Type I Glycogen Storage Disease Type IB Glycogen Storage Disease Xi Hepatorenal form of glycogen storage disease Kidney Diseases Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Renal Tubular Transport, Inborn Errors Urogenital Diseases Urologic Diseases

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Connecticut Children's

Hartford, Connecticut, 06106, United States

Location status: Recruiting

Location contact

Malaya Mount, MS, RD, CDN

CONTACT

[email protected]

860-837-6700

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactate Meter

Other

Hourly blood lactate levels

Accu Chek

Device

Hourly blood glucose levels

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

Study contacts

Contact information is provided by the study sponsor or research team.

Malaya Mount

CONTACT

3608889293

Malaya Mount, MS, RD, CDN

CONTACT

[email protected]

860-837-6700

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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