Diabetes MellitusJDRF-COENCT05609279
Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes
An observational study of Diabetes Mellitus, run by University of Michigan at 1 site in United States.
Trial summary
This study focuses on individuals with type 1 diabetes (T1D) and seeks to comprehensively study and understand several aspects of T1D including: susceptibility to hypoglycemia (low blood sugar) and improvement in hypoglycemia risk using of advanced diabetes technologies, such as continuous glucose monitoring (CGM)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 30 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants with type 1 diabetes previously enrolled and that participated in the University of Michigan T1D cohorts
Who may be able to join
- All participants with type 1 diabetes
- Previous enrollment and participation in the University of Michigan T1D cohorts (Natural History of Myocardial Dysfunction in T1D (HUM00036408); Targeting Inflammation with Salsalate in a T1D(HUM00169353); Preventing Early Renal Loss with Allopurinol in T1D (HUM00080944); and Tissue Specific Metabolic Reprogramming (HUM00060967)).
- Willing and able to participate in the study procedures described in the consent form.
- Willing to sign a written or electronic informed consent, including authorization to release health information.
- Fluent in spoken and written English.
- Willing to carry around their mobile phone/study mobile phone during the 14-day home monitoring period with daily access to cellular or WiFi connectivity.
Who cannot join
- Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation.
- Skin conditions or diseases that would interfere with the Continuous Glucose Monitor (CGM) sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
- Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor removal) that cannot be scheduled around or accommodated within the study assessment windows.
Trial locations and contacts
1 site in 1 country.
About this study
This study focuses on individuals with type 1 diabetes (T1D) and seeks to comprehensively study and understand several aspects of T1D including: susceptibility to hypoglycemia (low blood sugar) and improvement in hypoglycemia risk using of advanced diabetes technologies, such as continuous glucose monitoring (CGM); the differences among individuals with T1D in the risk of chronic complications, and minimize the psychosocial impact of T1D.
Read the detailed description
The study seeks to comprehensively study and understand several aspects of type 1 diabetes (T1D) including: the risk of low blood sugar and how that may be improved with new technologies; the variability (heterogeneity) among individuals in their risk of diabetes complications, and factors that could impact the psychosocial burdens of having T1D. The investigators want to learn of there are patient-specific systemic metabolomic profiles (substances detected in blood or urine) that lower the risk for hypoglycemia. Metabolomic analyses will be used to discover biological markers that could predict who is most likely to get diabetes complications, and how these risks might be changed, for example, by developing treatments targeted specifically to those biological markers. The investigators also plan to describe the relationship between metabolomic profiles, psychosocial states and cognitive function.
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, type-1 diabetes mellitus, endocrinology
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrolled participants providing serum samples for metabolomic analysis
Metabolomic samples will be requested from all study participants at the first (Visit 1) and last (Visit 3) study visit. The last study visit will be within 3 years of the first.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start18 Feb 2021
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Rodica Pop-Busui, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609279
- Sponsor's protocol ID
- HUM00185622
- Acronym
- JDRF-COE
- Status last verified
- Dec 2024
- First submitted
- 1 Nov 2022
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05609279
- Acronym / sponsor ID
- JDRF-COE / HUM00185622
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, type-1 diabetes mellitus, endocrinology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 8 Nov 2022 (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.
This study focuses on individuals with type 1 diabetes (T1D) and seeks to comprehensively study and understand several aspects of T1D including: susceptibility to hypoglycemia (low blood sugar) and improvement in hypoglycemia risk using of advanced diabetes technologies, such as continuous glucose monitoring (CGM); the differences among individuals with T1D in the risk of chronic complications, and minimize the psychosocial impact of T1D.
Detailed description
The study seeks to comprehensively study and understand several aspects of type 1 diabetes (T1D) including: the risk of low blood sugar and how that may be improved with new technologies; the variability (heterogeneity) among individuals in their risk of diabetes complications, and factors that could impact the psychosocial burdens of having T1D. The investigators want to learn of there are patient-specific systemic metabolomic profiles (substances detected in blood or urine) that lower the risk for hypoglycemia. Metabolomic analyses will be used to discover biological markers that could predict who is most likely to get diabetes complications, and how these risks might be changed, for example, by developing treatments targeted specifically to those biological markers. The investigators also plan to describe the relationship between metabolomic profiles, psychosocial states and cognitive function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants with type 1 diabetes previously enrolled and that participated in the University of Michigan T1D cohorts
Key inclusion criteria (6 listed)
- All participants with type 1 diabetes
- Previous enrollment and participation in the University of Michigan T1D cohorts (Natural History of Myocardial Dysfunction in T1D (HUM00036408); Targeting Inflammation with Salsalate in a T1D(HUM00169353); Preventing Early Renal Loss with Allopurinol in T1D (HUM00080944); and Tissue Specific Metabolic Reprogramming (HUM00060967)).
- Willing and able to participate in the study procedures described in the consent form.
- Willing to sign a written or electronic informed consent, including authorization to release health information.
- Fluent in spoken and written English.
Key exclusion criteria (3 listed)
- Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation.
- Skin conditions or diseases that would interfere with the Continuous Glucose Monitor (CGM) sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
- Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor removal) that cannot be scheduled around or accommodated within the study assessment windows.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of enrolled participants providing serum samples for metabolomic analysis
Time frame: 3 years
Metabolomic samples will be requested from all study participants at the first (Visit 1) and last (Visit 3) study visit. The last study visit will be within 3 years of the first.
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 13 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Mellitus, run by University of Michigan 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 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 13 Dec 2024. 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?
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?
Proportion of enrolled participants providing serum samples for metabolomic analysis (time frame: 3 years). 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 13 Dec 2024.