DiabetesNCT03232437
Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System
An observational study of Diabetes, run by Jana Care at 3 sites in United States.
Trial summary
A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following sites: 1. Forsyth Institute in Cambridge, MA 2. Orange County Research Center in Tustin, CA 3. ActivMed Practices \& Research in Methuen, MA Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Aina HbA1c Monitoring System
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jun 2017to 21 Jun 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy and Diabetic patients
Who may be able to join
- Agree to the terms of this consent form
- Sign this consent form
- Be 18 years or older
- Have an HbA1c measured by a reference method within the last three months or based on medical history that is expected to fall in the range of 4 to 15%
- Provide blood samples from your arm and finger
- Come in in the morning of the study visit
Who cannot join
- Not have a recent history of anemia or hemoglobin concentration above 20%
- Not be pregnant
- Not have previously given a blood sample to the Study Sponsor for a study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Forsyth Institute
Cambridge, Massachusetts, 02142
ActivMed Practices & Research
Methuen, Massachusetts, 01844
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Multicenter Study to Evaluate the External Precision of the Aina HbA1c Monitoring System in Quantitative Measurement of Glycosylated Hemoglobin (HbA1c)
A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following sites:
- Forsyth Institute in Cambridge, MA
- Orange County Research Center in Tustin, CA
- ActivMed Practices \& Research in Methuen, MA
Read the detailed description
Each site tested three identical samples of HbA1c, at three different levels of HbA1c measurement. Samples were drawn at the Forsyth Institute, received and blinded by the Sponsor, and returned to Forsyth Institute for testing. Samples were tested in triplicate, twice per day, over the course of five days, by three trained operators.
- Conditions
- Diabetes
- Being tested
- Aina HbA1c Monitoring System
- Keywords
- HbA1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aina HbA1c Monitoring SystemDevice
Monitoring test for quantitative determination of HbA1c
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision (as measured by %CV) of HbA1c measurements
HbA1c measured on 3 samples on the Aina HbA1c Monitoring System by 3 operators at each site.
Measured: Each sample was measured in triplicate, twice per day, over the course of five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start14 Jun 2017
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jana Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Forsyth Institute, Orange County Research Center, ActivMed Practices & Research
- Responsible party
- Sponsor
- Investigators
- Hatice Hasturk, PhD, Principal investigator, Forsyth InstituteJoel Neutel, MD, Principal investigator, Orange County Research CenterMichael McCartney, MD, Principal investigator, ActivMed Practices & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232437
- Sponsor's protocol ID
- A1C-FI-001
- Other IDs
- A1C-OCRC-001, A1C-AM-001
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2017
- Last updated
- 28 Jul 2017
- 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 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate the External Precision of the Aina HbA1c Monitoring System in Quantitative Measurement of Glycosylated Hemoglobin (HbA1c)
- ClinicalTrials.gov ID
- NCT03232437
- Acronym / sponsor ID
- A1C-FI-001
- Conditions
- Diabetes
- Keywords
- HbA1c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jana CareIndustry (pharma, biotech, devices)
- Collaborators
- The Forsyth Institute, Orange County Research Center, ActivMed Practices & Research
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 28 Jul 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.
A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following sites:
- Forsyth Institute in Cambridge, MA
- Orange County Research Center in Tustin, CA
- ActivMed Practices \& Research in Methuen, MA
Detailed description
Each site tested three identical samples of HbA1c, at three different levels of HbA1c measurement. Samples were drawn at the Forsyth Institute, received and blinded by the Sponsor, and returned to Forsyth Institute for testing. Samples were tested in triplicate, twice per day, over the course of five days, by three trained operators.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy and Diabetic patients
Key inclusion criteria (6 listed)
- Agree to the terms of this consent form
- Sign this consent form
- Be 18 years or older
- Have an HbA1c measured by a reference method within the last three months or based on medical history that is expected to fall in the range of 4 to 15%
- Provide blood samples from your arm and finger
Key exclusion criteria (3 listed)
- Not have a recent history of anemia or hemoglobin concentration above 20%
- Not be pregnant
- Not have previously given a blood sample to the Study Sponsor for a 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 |
|---|---|---|
| Aina HbA1c Monitoring SystemMonitoring test for quantitative determination of HbA1c | Device | – |
Primary outcome
Precision (as measured by %CV) of HbA1c measurements
Time frame: Each sample was measured in triplicate, twice per day, over the course of five days
HbA1c measured on 3 samples on the Aina HbA1c Monitoring System by 3 operators at each site.
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 28 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Hatice Hasturk, PhD principal investigator
Forsyth Institute
Joel Neutel, MD principal investigator
Orange County Research Center
Michael McCartney, MD principal investigator
ActivMed Practices & Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Jana Care at 3 sites 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 6 inclusion and 3 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 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Precision (as measured by %CV) of HbA1c measurements (time frame: Each sample was measured in triplicate, twice per day, over the course of five 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 28 Jul 2017.