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

May 29, 2026 updated by: Connecticut Children's Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Malaya Mount, MS, RD, CDN
Phone Number: 860-837-6700
Email: mmount@connecticutchildrens.org

Study Contact Backup

Name: Malaya Mount
Phone Number: 3608889293

Study Locations

United States
- Connecticut
  - Hartford, Connecticut, United States, 06106
    - Recruiting
    - Connecticut Children's
    - Contact:
      
      Malaya Mount, MS, RD, CDN
      
      Phone Number: 860-837-6700
      
      Email: mmount@connecticutchildrens.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Hourly x 8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Hourly x 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Connecticut Children's Medical Center

Collaborators

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

Investigators

Principal Investigator: Malaya Mount, MS, RD, CDN, Connecticut Children's
Principal Investigator: Rebecca Riba-Wolman, MD, Connecticut Children's

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria