NCT07459582 · Connecticut Children's Medical Center
Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease
What this study is about
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.
View original scientific description
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Hartford, Connecticut
Collaborators
Global Center for Glycogen Storage Disease held at the Jewish Community Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations