Glycogen Storage Disease Type IANCT07459582
Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease
An observational study of Glycogen Storage Disease Type IA and Glycogen Storage Disease Type I, run by Connecticut Children's Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Glycogen Storage Disease Type IA, Glycogen Storage Disease Type I, Glycogen Storage Disease Type IB
- What is being tested?
- Lactate Meter and Accu Chek
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2026to 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients birth to age 60 years with diagnosed Glycogen Storage Disease Type Ia/Ib or XI.
Who may be able to join
- 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
Who cannot join
- Patients with Glycogen storage disease unspecified
- Patients not meeting inclusion criteria
- Patients unable to provide consent
- Patients who decline to be in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaya Mount contact
United States1 site, 1 recruiting
- Recruiting
Connecticut Children's
Hartford, Connecticut, 06106
Malaya Mount, MS, RD, CDN, 860-837-6700, mmount@connecticutchildrens.org
About this study
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.
- Conditions
- Glycogen Storage Disease Type IA, Glycogen Storage Disease Type I, Glycogen Storage Disease Type IB, Glycogen Storage Disease Xi
- Being tested
- Lactate Meter, Accu Chek
- Keywords
- lactate, blood glucose
- Medical subject headings
- Hepatorenal form of glycogen storage disease, Glycogen Storage Disease Type I, Glycogen Storage Disease IB, Fanconi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate MeterOther
Hourly blood lactate levels
Accu ChekDevice
Hourly blood glucose levels
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Hourly x 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start18 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionDec 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
- Case only
- 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
- Responsible party
- Sponsor
- Investigators
- Malaya Mount, MS, RD, CDN, Principal investigator, Connecticut Children'sRebecca Riba-Wolman, MD, Principal investigator, Connecticut Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459582
- Sponsor's protocol ID
- 25-061
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease
- ClinicalTrials.gov ID
- NCT07459582
- Acronym / sponsor ID
- 25-061
- Conditions
- Glycogen Storage Disease Type IA, Glycogen Storage Disease Type I, Glycogen Storage Disease Type IB, Glycogen Storage Disease Xi
- Keywords
- lactate, blood glucose
- 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
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Mar 2026 (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 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients birth to age 60 years with diagnosed Glycogen Storage Disease Type Ia/Ib or XI.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patients with Glycogen storage disease unspecified
- Patients not meeting inclusion criteria
- Patients unable to provide consent
- Patients who decline to be in the study
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 |
|---|---|---|
| Lactate MeterHourly blood lactate levels | Other | – |
| Accu ChekHourly blood glucose levels | Device | – |
Primary outcome
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
1 secondary outcome
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
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 29 Oct 2026.
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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.
Malaya Mount contact
Malaya Mount, MS, RD, CDN principal investigator
Connecticut Children's
Rebecca Riba-Wolman, MD principal investigator
Connecticut Children's
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 and Glycogen Storage Disease Type I, 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 4 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 29 Oct 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, CDN (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?
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). 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 29 Oct 2026.