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RecruitingNCT07459582Updated Jun 1, 2026

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

An observational study in Glycogen Storage Disease Type IA, Glycogen Storage Disease Type I and Glycogen Storage Disease Type IB, sponsored by Connecticut Children's Medical Center. Recruiting at 1 site in United States. Open to participants aged Up to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Connecticut Children's Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
Up to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Glycogen Storage Disease Type IA
  • Glycogen Storage Disease Type I
  • Glycogen Storage Disease Type IB
  • Glycogen Storage Disease Xi

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Keywords

  • lactate
  • blood glucose
03

Who can participate

Ages eligible
Up to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  1. 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).
  2. For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document
  3. For adolescents: assent to participate
  4. For adults: Ability to understand and the willingness to sign a written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Patients with Glycogen storage disease unspecified
  2. Patients not meeting inclusion criteria
  3. Patients unable to provide consent
  4. Patients who decline to be in the study
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Interventions

  • OtherLactate Meter

    Hourly blood lactate levels

  • DeviceAccu Chek

    Hourly blood glucose levels

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • Connecticut Children's
    Hartford, Connecticut 06106, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT07459582
Lead sponsor
Connecticut Children's Medical Center
Collaborators
Global Center for Glycogen Storage Disease held at the Jewish Community Foundation
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Aug 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 1, 2026

Study contacts

Malaya Mount, MS, RD, CDN
Contact
mmount@connecticutchildrens.org
860-837-6700
Malaya Mount
Contact
3608889293
Malaya Mount, MS, RD, CDN
principal investigator · Connecticut Children's
Rebecca Riba-Wolman, MD
principal investigator · Connecticut Children's

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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