Diabetes Mellitus, Type 1 DiabetesiDose-EDCNCT07911033
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1 Diabetes and Cardiovascular Diseases (CVD), run by Rachel Miller at 1 site in United States.
Trial summary
The goal of this observational study is to better understand how the amount of insulin people with type 1 diabetes are using relates to blood glucose control and the risk of complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD), Severe Albuminuria
- What is being tested?
- Routine/prescribed exogenous insulin dose
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jun 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Pittsburgh EDC study cohort comprises 658 individuals diagnosed with type 1 diabetes before age 17 at Children's Hospital of Pittsburgh (or seen there within one year of their diabetes diagnosis) between 1950-1980. For Study Aim 1, data from the DCCT/EDIC study will also be evaluated. DCCT was a multicenter randomized controlled trial of people with type 1 diabetes, conducted between 1983-1993. Participants (n=1441) were randomly assigned to intensive insulin therapy (INT) or conventional therapy (CONV). Eligibility criteria included having type 1 diabetes for 1-15 years, no or minimal background retinopathy, and being normotensive. Study visits during the trial period occurred quarterly. Following the trial's conclusion, participants were enrolled in the observational follow-up study, EDIC, which has continued for over 30 years.
Who may be able to join
- Study Aim 1 - All existing participants of the Pittsburgh EDC study
- Study Aim 2 - Existing participants of the Pittsburgh EDC study who were alive and not withdrawn as of the most recent (2023-24) survey follow-up
Who cannot join
- Study Aim 1 - For each outcome of interest, individuals who already had the outcome at study baseline.
- Study Aim 2 - History of major cardiovascular disease, kidney failure, or pancreatic transplant
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
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Insulin Dose and Vascular Complications in Type 1 Diabetes: Its Role Beyond Insulin Resistance and Glycemia
The goal of this observational study is to better understand how the amount of insulin people with type 1 diabetes are using relates to blood glucose control and the risk of complications. The main questions this study aims to answer are: 1) Is insulin dose related to the long-term risk of developing heart disease, kidney disease and other complications in people with type 1 diabetes, after accounting for blood glucose? and 2) Does insulin dose relate to early signs of heart and kidney disease (i.e., disease that is not clinically detectable) in people with type 1 diabetes who are using modern diabetes management regimens?
Read the detailed description
Study Aim 1 will use existing data from the prospective Pittsburgh Epidemiology of Diabetes Complications (EDC) study cohort, comprising 658 study participants who were diagnosed with type 1 diabetes in childhood (<17 years old) and followed for health outcomes and clinical measures for up to 37 years beginning in 1986. Prospective analyses of this existing data will be conducted. Existing data from the DCCT/EDIC study will be used to externally validate EDC study findings.
Study Aim 2 will collect new data from 80 EDC study participants without a history of cardiovascular disease, kidney failure, or a pancreatic transplant. They will be asked to respond to survey questions on their health history, medications, physical activity, and diet, provide 2 overnight urine samples; provide 2 weeks of data from their insulin delivery device (e.g., insulin pump) and/or a continuous glucose monitor (CGM) or keep a manual log of their insulin doses and blood glucose for 2 weeks; and attend a clinical visit, where we will measure their height and weight, blood pressure, collect an additional urine sample and a blood sample, and conduct non-invasive tests to measure early signs of cardiovascular disease (pulse wave velocity and coronary artery calcium scan) and kidney disease (urinary albumin creatinine ratio and estimated glomerular filtration rate).
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD), Severe Albuminuria, Estimated Glomerular Filtration Rate (eGFR), Hypoglycemia (Diabetic), Vascular Calcification
- Being tested
- Routine/prescribed exogenous insulin dose
- Keywords
- Type 1 diabetes, insulin dose, diabetes complications, coronary artery calcium, CAC, kidney disease, albuminuria, UACR, eGFR, pulse wave velocity
- Medical subject headings
- Diabetes Mellitus, Type 1, Cardiovascular Diseases, Albuminuria, Hypoglycemia, Vascular Calcification, Kidney Diseases, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine/prescribed exogenous insulin doseDrug
Aim 1: Participants will be observed under their self-reported, routine, physician-directed insulin doses using existing historical data since 1986-88.
Aim 2: Data on routine, physician-directed insulin dose over the past 2 weeks will be downloaded from insulin delivery devices (pumps, smart pens). Participants not using such devices will complete manual insulin dose log sheets for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Epidemiology of Diabetes Complications (EDC) study cohort | The EDC is a cohort of individuals with childhood-onset (<17 years at diagnosis) type 1 diabetes, diagnosed or seen within 1 year of diabetes diagnosis at Children's Hospital of Pittsburgh. The cohort has been followed since 1986-88, thus the study comprises up to 30 years of longitudinal data on clinical risk factors and up to 37 years of data on complication endpoints ascertained by standardized protocols. EDC has been shown to be epidemiologically representative of the type 1 diabetes population in the surrounding western Pennsylvania. Receives: Drug: Routine/prescribed exogenous insulin dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Total Composite Cardiovascular Disease (CVD) Endpoint
Time from study baseline to the first instance of CVD death, myocardial infarction (MI), coronary revascularization, blockage ≥50%, ischemic ECG at study visit, study physician-diagnosed angina, or stroke. Participants not experiencing CVD will be censored at their last event-free follow-up.
Measured: Up to 37 years.
Time to First Instance of Severely Increased Albuminuria (SIA)
Time from study baseline to the first instance of albumin excretion rate ≥200 µg/min or albumin-creatinine ratio ≥300 mg/g in ≥2 of 3 timed urine specimens (24-hour, overnight, 4 hour clinic specimen). Participants not experiencing SIA will be censored at their last event-free follow-up.
Measured: Up to 30 years.
Time to Sustained Estimated Glomerular Filtration Rate (eGFR) Decline
Time from study baseline to the first instance of two consecutive visits with eGFR<60 ml/min/1.73m^2. Participants not experiencing sustained eGFR decline will be censored at their last event-free follow-up.
Measured: Up to 30 years.
Proportion of Participants Experiencing Level 3 Hypoglycemia
Count of severe hypoglyemia events characterized by altered mental and/or physical status requiring assistance.
Measured: Up to 37 years.
Coronary Artery Calcification (CAC) Score
Participants with a CAC Agatston score >100, which is considered moderate or greater coronary plaque build-up, indicating an increased risk of heart disease.
Measured: Measured at 41 years.
Carotid-Femoral Pulse Wave Velocity (cfPWV) Measurement
Participants with a cfPWV > 10 m/s.
Measured: Measured at 41 years.
Estimated Glomerular Filtration Rate (eGFR) Measurement
eGFR calculated using serum creatinine.
Measured: Measured at 41 years.
Secondary outcomes (10)
Time to First Major Adverse Cardiovascular Event (MACE)
Time from study baseline to the first instance of CVD death, MI, or stroke. Participants not experiencing MACE will be censored at their last event-free follow-up.
Measured: Up to 37 years.
Time to First Total Coronary Artery Disease (tCAD) Event
Time from study baseline to the first instance of CAD death, MI, coronary revascularization, ischemic ECG at study visit, or study physician-diagnosed angina. Participants not experiencing tCAD will be censored at their last event-free follow-up.
Measured: Up to 37 years.
Time to First Hard Coronary Artery Disease (hCAD) Event
Time from study baseline to the first instance of CAD death, MI, or coronary revascularization. Participants not experiencing hCAD will be censored at their last event-free follow-up.
Measured: Up to 37 years.
Time to First Instance of Moderately Increased Albuminuria (MIA)
Time from study baseline to the first instance of albumin excretion rate 20-200 µg/min or albumin-creatinine ratio 30-300 mg/g in ≥2 of 3 timed urine specimens (24-hr, overnight, 4 hr clinic specimen). Participants not experiencing MIA will be censored at their last event-free follow-up.
Measured: Up to 30 years.
Time to First Instance of Proliferative Diabetic Retinopathy (PDR)
Time from study baseline to the first instance of ETDRS grade ≥60 on retinal fundus photos or laser photocoagulation for PDR. Participants not experiencing PDR will be censored at their last event-free follow-up.
Measured: Up to 30 years.
Time to First Instance of Distal Symmetric Polyneuropathy (DSP)
Time from study baseline to the first instance of the presence of two or more of the following as assessed by a study physician: DSP symptoms, sensory and/or motor signs, and/or absent (or present only with reinforcement) tendon reflexes. Participants not experiencing DSP will be censored at their last event-free follow-up.
Measured: Up to 30 years.
Time to First Instance of Autonomic Neuropathy (AN)
Time from study baseline to the first instance of AN. AN is assessed using heart rate response to deep breathing (expiration to inspiration ratio). A ratio of <1.1 is considered AN. Participants not experiencing AN will be censored at their last event-free follow-up.
Measured: Up to 30 years.
Time to First Instance of Lower Extremity Arterial Disease (LEAD)
Resting ankle-brachial systolic blood pressures are taken in the supine position with a Doppler blood-flow detector. Ankle-to-brachial index (ABI) is calculated using the brachial pressure measurement taken closest in time to the ankle (right and left tibialis posterior and dorsalis pedis) pressures. LEAD is defined as the first instance of ABI < 0.8 on either side at rest, and/or a history of claudication as determined by questionnaire, and/or self-reported history of amputation for ischemia. Participants not experiencing LEAD will be censored at their last event-free follow-up.
Measured: Up to 30 years.
Time to First Instance of End-Stage Kidney Disease (ESKD)
Time from study baseline to the first instance of renal dialysis or kidney transplant. Participants not experiencing ESKD will be censored at their last event-free follow-up.
Measured: Up to 37 years.
Urinary Albumin to Creatinine Ratio (UACR) Measurement
Participants with UACR (median from 3 timed urine specimens: 2 overnight, 4-hour clinic specimen) > 30 mg/g.
Measured: Measured at 41 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1 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
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rachel Miller
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor-investigator, Rachel Miller, University of Pittsburgh
- Investigators
- Rachel Miller, PhD, Principal investigator, University of PittsburghTina Costacou, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911033
- Sponsor's protocol ID
- STUDY26050084
- Other IDs
- 3-SRA-2026-1951-M-B
- Acronym
- iDose-EDC
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Historical EDC study consent forms include language that prohibits individual-level data sharing with external investigators, so only summary-level results may be shared for Study Aim 1. The DCCT/EDIC data is available for eligible investigators who apply for access under a data use agreement with the NIDDK Central Repository. For Study Aim 2, the new informed consent form specifies that de-identified IPD may be shared with external investigators and/or national repositories. De-identified IDP generated in Aim 2 will be cleaned and deposited into an approved repository concurrently with the publication of their associated primary findings.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Dose and Vascular Complications in Type 1 Diabetes: Its Role Beyond Insulin Resistance and Glycemia
- ClinicalTrials.gov ID
- NCT07911033
- Acronym / sponsor ID
- iDose-EDC / STUDY26050084
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD), Severe Albuminuria, Estimated Glomerular Filtration Rate (eGFR), Hypoglycemia (Diabetic), Vascular Calcification
- Keywords
- Type 1 diabetes, insulin dose, diabetes complications, coronary artery calcium, CAC, kidney disease, albuminuria, UACR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rachel MillerUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 2 Nov 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 observational study is to better understand how the amount of insulin people with type 1 diabetes are using relates to blood glucose control and the risk of complications. The main questions this study aims to answer are: 1) Is insulin dose related to the long-term risk of developing heart disease, kidney disease and other complications in people with type 1 diabetes, after accounting for blood glucose? and 2) Does insulin dose relate to early signs of heart and kidney disease (i.e., disease that is not clinically detectable) in people with type 1 diabetes who are using modern diabetes management regimens?
Detailed description
Study Aim 1 will use existing data from the prospective Pittsburgh Epidemiology of Diabetes Complications (EDC) study cohort, comprising 658 study participants who were diagnosed with type 1 diabetes in childhood (<17 years old) and followed for health outcomes and clinical measures for up to 37 years beginning in 1986. Prospective analyses of this existing data will be conducted. Existing data from the DCCT/EDIC study will be used to externally validate EDC study findings.
Study Aim 2 will collect new data from 80 EDC study participants without a history of cardiovascular disease, kidney failure, or a pancreatic transplant. They will be asked to respond to survey questions on their health history, medications, physical activity, and diet, provide 2 overnight urine samples; provide 2 weeks of data from their insulin delivery device (e.g., insulin pump) and/or a continuous glucose monitor (CGM) or keep a manual log of their insulin doses and blood glucose for 2 weeks; and attend a clinical visit, where we will measure their height and weight, blood pressure, collect an additional urine sample and a blood sample, and conduct non-invasive tests to measure early signs of cardiovascular disease (pulse wave velocity and coronary artery calcium scan) and kidney disease (urinary albumin creatinine ratio and estimated glomerular filtration rate).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidemiology of Diabetes Complications (EDC) study cohort | – | Drug: Routine/prescribed exogenous insulin doseThe EDC is a cohort of individuals with childhood-onset (<17 years at diagnosis) type 1 diabetes, diagnosed or seen within 1 year of diabetes diagnosis at Children's Hospital of Pittsburgh. The cohort has been followed since 1986-88, thus the study comprises up to 30 years of longitudinal data on clinical risk factors and up to 37 years of data on complication endpoints ascertained by standardized protocols. EDC has been shown to be epidemiologically representative of the type 1 diabetes population in the surrounding western Pennsylvania. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Pittsburgh EDC study cohort comprises 658 individuals diagnosed with type 1 diabetes before age 17 at Children's Hospital of Pittsburgh (or seen there within one year of their diabetes diagnosis) between 1950-1980. For Study Aim 1, data from the DCCT/EDIC study will also be evaluated. DCCT was a multicenter randomized controlled trial of people with type 1 diabetes, conducted between 1983-1993. Participants (n=1441) were randomly assigned to intensive insulin therapy (INT) or conventional therapy (CONV). Eligibility criteria included having type 1 diabetes for 1-15 years, no or minimal background retinopathy, and being normotensive. Study visits during the trial period occurred quarterly. Following the trial's conclusion, participants were enrolled in the observational follow-up study, EDIC, which has continued for over 30 years.
Key inclusion criteria (2 listed)
- Study Aim 1 - All existing participants of the Pittsburgh EDC study
- Study Aim 2 - Existing participants of the Pittsburgh EDC study who were alive and not withdrawn as of the most recent (2023-24) survey follow-up
Key exclusion criteria (2 listed)
- Study Aim 1 - For each outcome of interest, individuals who already had the outcome at study baseline.
- Study Aim 2 - History of major cardiovascular disease, kidney failure, or pancreatic transplant
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 |
|---|---|---|
| Routine/prescribed exogenous insulin doseAim 1: Participants will be observed under their self-reported, routine, physician-directed insulin doses using existing historical data since 1986-88. Aim 2: Data on routine, physician-directed insulin dose over the past 2 weeks will be downloaded from insulin delivery devices (pumps, smart pens). Participants not using such devices will complete manual insulin dose log sheets for 2 weeks. | Drug | Epidemiology of Diabetes Complications (EDC) study cohort |
Primary outcome
Time to First Total Composite Cardiovascular Disease (CVD) Endpoint
Time frame: Up to 37 years.
Time from study baseline to the first instance of CVD death, myocardial infarction (MI), coronary revascularization, blockage ≥50%, ischemic ECG at study visit, study physician-diagnosed angina, or stroke. Participants not experiencing CVD will be censored at their last event-free follow-up.
Time to First Instance of Severely Increased Albuminuria (SIA)
Time frame: Up to 30 years.
Time from study baseline to the first instance of albumin excretion rate ≥200 µg/min or albumin-creatinine ratio ≥300 mg/g in ≥2 of 3 timed urine specimens (24-hour, overnight, 4 hour clinic specimen). Participants not experiencing SIA will be censored at their last event-free follow-up.
Time to Sustained Estimated Glomerular Filtration Rate (eGFR) Decline
Time frame: Up to 30 years.
Time from study baseline to the first instance of two consecutive visits with eGFR<60 ml/min/1.73m^2. Participants not experiencing sustained eGFR decline will be censored at their last event-free follow-up.
Proportion of Participants Experiencing Level 3 Hypoglycemia
Time frame: Up to 37 years.
Count of severe hypoglyemia events characterized by altered mental and/or physical status requiring assistance.
Coronary Artery Calcification (CAC) Score
Time frame: Measured at 41 years.
Participants with a CAC Agatston score >100, which is considered moderate or greater coronary plaque build-up, indicating an increased risk of heart disease.
Carotid-Femoral Pulse Wave Velocity (cfPWV) Measurement
Time frame: Measured at 41 years.
Participants with a cfPWV > 10 m/s.
Estimated Glomerular Filtration Rate (eGFR) Measurement
Time frame: Measured at 41 years.
eGFR calculated using serum creatinine.
10 secondary outcomes
Time to First Major Adverse Cardiovascular Event (MACE)
Time frame: Up to 37 years.
Time to First Total Coronary Artery Disease (tCAD) Event
Time frame: Up to 37 years.
Time to First Hard Coronary Artery Disease (hCAD) Event
Time frame: Up to 37 years.
Time to First Instance of Moderately Increased Albuminuria (MIA)
Time frame: Up to 30 years.
Time to First Instance of Proliferative Diabetic Retinopathy (PDR)
Time frame: Up to 30 years.
Time to First Instance of Distal Symmetric Polyneuropathy (DSP)
Time frame: Up to 30 years.
Time to First Instance of Autonomic Neuropathy (AN)
Time frame: Up to 30 years.
Time to First Instance of Lower Extremity Arterial Disease (LEAD)
Time frame: Up to 30 years.
Time to First Instance of End-Stage Kidney Disease (ESKD)
Time frame: Up to 37 years.
Urinary Albumin to Creatinine Ratio (UACR) Measurement
Time frame: Measured at 41 years.
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 2 Nov 2026.
- Individual participant dataSharing planned: Yes. Historical EDC study consent forms include language that prohibits individual-level data sharing with external investigators, so only summary-level results may be shared for Study Aim 1. The DCCT/EDIC data is available for eligible investigators who apply for access under a data use agreement with the NIDDK Central Repository. For Study Aim 2, the new informed consent form specifies that de-identified IPD may be shared with external investigators and/or national repositories. De-identified IDP generated in Aim 2 will be cleaned and deposited into an approved repository concurrently with the publication of their associated primary findings.
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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.
Rachel Miller, PhD principal investigator
University of Pittsburgh
Tina Costacou, PhD principal investigator
University of Pittsburgh
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, Type 1 Diabetes and Cardiovascular Diseases (CVD), run by Rachel Miller 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 2 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: opening soon, as of the sponsor's last update on 2 Nov 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 Clinical Coordinator (412-889-7406, KLS302@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Total Composite Cardiovascular Disease (CVD) Endpoint (time frame: Up to 37 years.). The study lists 7 primary outcomes in all. 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 2 Nov 2026.