An observational study in Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD) and Severe Albuminuria, sponsored by Rachel Miller. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Rachel Miller · Observational
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?
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).
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 80 is below the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Rachel Miller is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: Routine/prescribed exogenous insulin dose
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at 41 years.
Carotid-Femoral Pulse Wave Velocity (cfPWV) Measurement
Participants with a cfPWV \> 10 m/s.
Time frame: Measured at 41 years.
Estimated Glomerular Filtration Rate (eGFR) Measurement
eGFR calculated using serum creatinine.
Time frame: Measured at 41 years.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at 41 years.
Plan to share: 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.
Time frame: IDP corresponding to Study Aim 2 will be made available concurrently with the publication of the primary findings or by December 31, 2029 (whichever comes first). IDP will be shared indefinitely.
Access criteria: Summary-level statistical results from Aim 1, newly generated subclinical measurements from Aim 2, and accompanying documentation will be securely hosted in the persistent public repository Figshare (e.g.,https://hra.figshare.com).
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2028, 23 months later.
Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 23 months is below that.
Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Rachel Miller