Actively Recruiting
Are Portable Lactate Monitoring Devices Accurate in Patients With Glycogen Storage Disease Ia Compared to Blood Serum Lactates?
Led by Connecticut Children's Medical Center · Updated on 2026-03-06
10
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
C
Connecticut Children's Medical Center
Lead Sponsor
G
Global Center for Glycogen Storage Disease held at the Jewish Community Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This observational study is focused on patients with glycogen storage disease type 1a. Researchers aim to determine how accurate home lactate meters, which use capillary and serum samples, are compared to laboratory serum lactate measurements. The study also evaluates the accuracy of the Accu Chek Guide glucometer, which uses capillary samples, in the same patient population. Participants will use home devices to measure blood lactate and glucose levels via finger-stick samples. These home measurements will be compared to lab results to assess accuracy within 20% of the lab values 95% of the time. The study involves monitoring these readings every 1 to 3 hours for up to 33 hours. Participants will be observed during their visits or admissions to Connecticut Children's Medical Center. Data collection includes frequent home meter readings and laboratory tests to compare results. The primary outcome is the accuracy of the home lactate meters, while the glucometer accuracy is a secondary outcome. The study runs from April 2025 until December 2027, and participants may be monitored for up to 33 hours during data collection periods.
CONDITIONS
Brief Title
Accuracy of Lactate Meter in GSDIa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with glycogen storage disease type 1a confirmed by liver biopsy or genetic testing
- Patients visiting or admitted to Connecticut Children's Medical Center during the study period
- For children, parent or legal guardian must understand and be willing to sign consent
- Adults must be able to understand and willing to sign informed consent
You will not qualify if you...
- Patients with glycogen storage disease unspecified or type Ib
- Patients who do not meet the inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 33 hours
Participants use portable lactate and glucose meters to measure blood levels at home, comparing these to lab serum readings.
Measurements every 1 to 3 hours during monitoring period
Trial Site Locations
Total: 1 location
1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06107
Actively Recruiting
Research Team
M
Malaya Mount, MS, RD
R
Rebecca Riba-Wolman, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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