DiabetesPhase 1NCT03073070
RBC Lifespan Measurement in Diabetic Children
A Phase 1 study testing biotin labeled RBCs in people with Diabetes and Red Blood Cell Survival, run by Guohua An at 1 site in United States.
Trial summary
HbA1c, a measure of mean blood glucose over the lifespan of a red blood cell (RBC), is a marker of increasing importance both for assessing glycemic control in children with known diabetes and for the diagnosis of diabetes in children. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Diabetes, Red Blood Cell Survival
- What is being tested?
- biotin labeled RBCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 15 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with either type1 or type 2 diabetes between 4-18 years old
Who cannot join
- consumption of biotin supplements or raw eggs within 30 days;
- history of gastrointestinal blood loss;
- heart failure ;
- active viral or bacterial infection;
- hemoglobinopathy;
- prior history of liver disease with transaminases more than 3 times the upper limit of normal for age;
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- uncontrolled thyroid disease;
- anemia (whole blood HCT<33);
- history of renal disease (prior serum creatinine more than >1.5 mg/dlL);
- detectable antibody to biotin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Red Blood Cell Lifespan Measurement in Diabetic Children
HbA1c, a measure of mean blood glucose over the lifespan of a red blood cell (RBC), is a marker of increasing importance both for assessing glycemic control in children with known diabetes and for the diagnosis of diabetes in children. HbA1c has demonstrated poor reliability in diagnosis and management of pediatric diabetes and the most plausible reason for this unreliability is that the reference ranges of HbA1c were established based on 120-day RBC lifespan observed in adults, without considering the RBC lifespan difference between children and adults. The proposed studies will for the first time determine RBC lifespan in diabetic children
Read the detailed description
Screening visit: There will be one screening visit before the study. We will do some blood tests that will determine if the subjects can be in this study. If the subject is qualify, he/she will be asked to return for the following scheduled visits.
Study visit 1: We will draw a small amount of subject's blood from the IV. The study subject's blood will then be marked with biotin. We will give back the subject's blood marked with biotin through IV within 4 to 6 hours. Endotoxin analysis (conducted pre-infusion) and bacterial culture analysis (conducted post-infusion) will be performed. Twenty minutes after the blood transfusion, we will draw blood from the IV. After that, we will take out the IV and the subject can go home.
All follow-up study visits:
The subject will have a study visit 24 hours after receiving blood marked with biotin. After that, the subject will have a clinic visit every 7-10 days. These visits will end when we can no longer find the biotin marked blood cells in the subject's blood. This is expected to be approximately 12 weeks later.
At these visits, we will draw blood and also collect all blood glucose results in the past 7-10 days.
After the study visits are completed, there will be one follow-up visit 4-6 months after the subject receives the biotin marked RBCs. We will draw about 0.25 ml of blood.
Continuous glucose monitoring and HbA1c determination-- We will monitor continuous glucose concentrations throughout the study. This will be accomplished by setting up FreeStyle Libre Pro continuous glucose monitoring (CGM) device for each study subject. In addition, HbA1c will be measured once in the middle of the study (likely visit 6) and in the end of the study (likely visit 12).
- Conditions
- Diabetes, Red Blood Cell Survival
- Being tested
- biotin labeled RBCs
- Keywords
- diabetic children, RBC lifespan
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biotin labeled RBCsDrug
Also called biotinylated RBCs
Autologous red blood cells are biotin labeled and transfused to the subjects. Survival of these red blood cells is tracked through examination of blood samples until no biotin-labeled red blood cells is detectable.
| Study group | Role | What they receive |
|---|---|---|
| Biotin labeled RBCs in 4-10 year old diabetes children | Experimental | Biotin labeled autologous RBCs will be transfused to the subjects Receives: Drug: biotin labeled RBCs |
| Biotin labeled RBCs in 10-18 year old diabetes children | Experimental | Biotin labeled autologous red blood cells will be transfused to the subjects Receives: Drug: biotin labeled RBCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of RBC survival in diabetic children using biotin-labeled RBCs
the lifespan of red blood cells in children with diabetes
Measured: 50 days to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start15 Nov 2017
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guohua An
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guohua An, University of Iowa
- Investigators
- Guohua An, MD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073070
- Sponsor's protocol ID
- 201612763
- Status last verified
- Feb 2022
- First submitted
- 18 Dec 2016
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Lifespan Measurement in Diabetic Children
- ClinicalTrials.gov ID
- NCT03073070
- Acronym / sponsor ID
- 201612763
- Conditions
- Diabetes, Red Blood Cell Survival
- Keywords
- diabetic children, RBC lifespan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Guohua AnUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 8 Mar 2017 (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.
HbA1c, a measure of mean blood glucose over the lifespan of a red blood cell (RBC), is a marker of increasing importance both for assessing glycemic control in children with known diabetes and for the diagnosis of diabetes in children. HbA1c has demonstrated poor reliability in diagnosis and management of pediatric diabetes and the most plausible reason for this unreliability is that the reference ranges of HbA1c were established based on 120-day RBC lifespan observed in adults, without considering the RBC lifespan difference between children and adults. The proposed studies will for the first time determine RBC lifespan in diabetic children
Detailed description
Screening visit: There will be one screening visit before the study. We will do some blood tests that will determine if the subjects can be in this study. If the subject is qualify, he/she will be asked to return for the following scheduled visits.
Study visit 1: We will draw a small amount of subject's blood from the IV. The study subject's blood will then be marked with biotin. We will give back the subject's blood marked with biotin through IV within 4 to 6 hours. Endotoxin analysis (conducted pre-infusion) and bacterial culture analysis (conducted post-infusion) will be performed. Twenty minutes after the blood transfusion, we will draw blood from the IV. After that, we will take out the IV and the subject can go home.
All follow-up study visits:
The subject will have a study visit 24 hours after receiving blood marked with biotin. After that, the subject will have a clinic visit every 7-10 days. These visits will end when we can no longer find the biotin marked blood cells in the subject's blood. This is expected to be approximately 12 weeks later.
At these visits, we will draw blood and also collect all blood glucose results in the past 7-10 days.
After the study visits are completed, there will be one follow-up visit 4-6 months after the subject receives the biotin marked RBCs. We will draw about 0.25 ml of blood.
Continuous glucose monitoring and HbA1c determination-- We will monitor continuous glucose concentrations throughout the study. This will be accomplished by setting up FreeStyle Libre Pro continuous glucose monitoring (CGM) device for each study subject. In addition, HbA1c will be measured once in the middle of the study (likely visit 6) and in the end of the study (likely visit 12).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biotin labeled RBCs in 4-10 year old diabetes children | Experimental | Drug: biotin labeled RBCsBiotin labeled autologous RBCs will be transfused to the subjects |
| Biotin labeled RBCs in 10-18 year old diabetes children | Experimental | Drug: biotin labeled RBCsBiotin labeled autologous red blood cells will be transfused to the subjects |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children with either type1 or type 2 diabetes between 4-18 years old
Key exclusion criteria (10 listed)
- consumption of biotin supplements or raw eggs within 30 days;
- history of gastrointestinal blood loss;
- heart failure ;
- active viral or bacterial infection;
- hemoglobinopathy;
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 |
|---|---|---|
| biotin labeled RBCsAlso: biotinylated RBCsAutologous red blood cells are biotin labeled and transfused to the subjects. Survival of these red blood cells is tracked through examination of blood samples until no biotin-labeled red blood cells is detectable. | Drug | Biotin labeled RBCs in 10-18 year old diabetes children, Biotin labeled RBCs in 4-10 year old diabetes children |
Primary outcome
Measurement of RBC survival in diabetic children using biotin-labeled RBCs
Time frame: 50 days to 120 days
the lifespan of red blood cells in children with diabetes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- 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. This study is not recruiting at the moment.
Guohua An, MD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing biotin labeled RBCs in people with Diabetes and Red Blood Cell Survival, run by Guohua An 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 8 Feb 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of RBC survival in diabetic children using biotin-labeled RBCs (time frame: 50 days to 120 days). 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 8 Feb 2022.