Glycogen Storage Disease Type IaNCT06843330
Accuracy of Lactate Meter in GSDIa
An observational study of Glycogen Storage Disease Type Ia, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, compared to lab serum lactate in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, in a population… Read more about this study
- Who is it for?
- Ages 0 to 60 years
- Conditions the study is for
- Glycogen Storage Disease Type Ia
- What is being tested?
- blood glucose meter; blood lactate meter
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to 10 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients of Connecticut Children's birth to age 60 years with diagnosed Glycogen Storage Disease Type Ia, that are seen in clinic between 7/2020 - 7/2024, or that present to emergency room or are admitted to Connecticut Children's for surgery, acute illness or dose titration admission.
Who may be able to join
- Patients with diagnosed/confirmed (by liver biopsy or genetic testing) Glycogen Storage Disease Type Ia (ICD 10 code: E74.01).
- Connecticut Children's Emergency Department visit and/or admission to Connecticut Children's during time study is active
- For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document
- For adults: Ability to understand and the willingness to sign a written informed consent
Who cannot join
- Patients with Glycogen storage disease unspecified 74.00, or Ib
- Patients not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06107
Rebecca Riba-Wolman, 860-837-6700, rriba@connecticutchildrens.org
About this study
Official title: Are Portable Lactate Monitoring Devices Accurate in Patients With Glycogen Storage Disease Ia When Compared to Blood Serum Lactates?
The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, compared to lab serum lactate in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, in a population of patients with glycogen storage disease type 1a.
Read the detailed description
The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type 1a.
- Conditions
- Glycogen Storage Disease Type Ia
- Being tested
- blood glucose meter; blood lactate meter
- Keywords
- Glycogen Storage Disease type Ia, Blood lactate, Glycogen Storage Disease Ia blood glucose, GSD I, GSDIa, Blood glucose, Accu chek glucometer, Lactate plus
- Medical subject headings
- Hepatorenal form of glycogen storage disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood glucose meter; blood lactate meterDevice
Blood lactate level measured by finger-stick with over the counter meter. Blood glucose level measured by finger-stick.
What is being measured
The primary outcome is the main question the study is designed to answer.
Home lactate meter accuracy in GSDIa compared with lab lactate
Lactate level via point of care finger-stick and lab draw
Measured: Every 1-3 hours for a maximum 33 hours
Secondary outcomes (1)
Glucometer accuracy in GSDIa compared with lab lactate
Glucose level via finger-stick and lab draw
Measured: Every 1-3 hours for a maximum 33 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start14 Apr 2025
- Primary completion10 Mar 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycogen Storage Disease Type IaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Global Center for Glycogen Storage Disease held at the Jewish Community Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843330
- Sponsor's protocol ID
- 23-137
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Portable Lactate Monitoring Devices Accurate in Patients With Glycogen Storage Disease Ia When Compared to Blood Serum Lactates?
- ClinicalTrials.gov ID
- NCT06843330
- Acronym / sponsor ID
- 23-137
- Conditions
- Glycogen Storage Disease Type Ia
- Keywords
- Glycogen Storage Disease type Ia, Blood lactate, Glycogen Storage Disease Ia blood glucose, GSD I, GSDIa, Blood glucose, Accu chek glucometer, Lactate plus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- Global Center for Glycogen Storage Disease held at the Jewish Community Foundation
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, compared to lab serum lactate in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, in a population of patients with glycogen storage disease type 1a.
Detailed description
The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type 1a.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients of Connecticut Children's birth to age 60 years with diagnosed Glycogen Storage Disease Type Ia, that are seen in clinic between 7/2020 - 7/2024, or that present to emergency room or are admitted to Connecticut Children's for surgery, acute illness or dose titration admission.
Key inclusion criteria (4 listed)
- Patients with diagnosed/confirmed (by liver biopsy or genetic testing) Glycogen Storage Disease Type Ia (ICD 10 code: E74.01).
- Connecticut Children's Emergency Department visit and/or admission to Connecticut Children's during time study is active
- For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document
- For adults: Ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (2 listed)
- Patients with Glycogen storage disease unspecified 74.00, or Ib
- Patients not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood glucose meter; blood lactate meterBlood lactate level measured by finger-stick with over the counter meter. Blood glucose level measured by finger-stick. | Device | – |
Primary outcome
Home lactate meter accuracy in GSDIa compared with lab lactate
Time frame: Every 1-3 hours for a maximum 33 hours
Lactate level via point of care finger-stick and lab draw
1 secondary outcome
Glucometer accuracy in GSDIa compared with lab lactate
Time frame: Every 1-3 hours for a maximum 33 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glycogen Storage Disease Type Ia, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malaya Mount, MS, RD (860-837-6700, mmount@connecticutchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home lactate meter accuracy in GSDIa compared with lab lactate (time frame: Every 1-3 hours for a maximum 33 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.