The Sanford Project for Type 1 Diabetes
Sanford Project is one of the four Sanford Health initiatives made possible through Denny Sanford’s $400 million gift. A subsequent gift of $10 million was made to The Sanford Project by the Todd & Linda Broin family.
Our Work to End Type 1 Diabetes
The Sanford Project team designs and conducts pre-clinical and clinical studies focused on two key areas:
- Basic science efforts focused on the autoimmunity that causes T1D and ways to target that process.
- Clinical research that spans from screening programs through pre-symptomatic T1D and established disease.
People At-Risk: Includes people with a single positive antibody or those with genetic risk for T1D who have not yet reached Stage 1. At this stage, monitoring is designed to detect progression to Stage 1, typically by periodic testing for anti-islet autoantibodies.
Screening and Clinical Research
- Newborn GRS-2
- Relatives of People with T1D: Diabetes TrialNet has been screening family members with T1D since [2001]. Sanford Health continues to be an active affiliate in the TrialNet network, providing screening and intervention trials.
- General Population Screening: Since 90% of people with T1D do not have a family history of T1D, general population screening is warranted to find children at risk for T1D. The Sanford PLEDGE Study is integrating this screening into routine pediatric care delivery at Sanford primary care clinics.
Stage 1 (normal glucose): Autoimmunity has begun, and the person still has normal glucose tolerance. Overall, about 2 of every 10 (20%) individuals at Stage 1 T1D will progress to Stage 2 within four years. Trials aim to delay or prevent the progression to Stage 2 T1D. With this lower risk and unclear rate of progression, tolerance of risks associated with interventions is lower than in Stage 2, and the safety profile of agents is paramount.
Clinical Trials:
- TN-22: Hydroxycholoquine (completed)
Stage 2 (impaired glucose tolerance): Glucose tolerance is impaired, but the person does not yet meet criteria for clinical diagnosis of T1D (Stage 3). Approximately 5 of every 10 people in Stage 2 will progress to Stage 3 within two years. Stage 2 trials aim to delay or prevent the progression to Stage 3. In early-stage T1D, the risk tolerance for interventions is lower. Stage 2 trials focus on interventions that have already demonstrated prospective benefits in Stage 3, e.g., teplizumab or antithymocyte globulin (ATG).
Clinical Trials:
- In Startup:
- PETITE-T1D (Teplizumab < 8 yo)
- Completed:
- TrialNet Oral Insulin Study
- TN-10: Teplizumab (anti-CD3)
Stage 3 (overt hyperglycemia “new-onset”): New-onset trials of immunotherapies to preserve remaining insulin production. In Stage 3 people have overt hyperglycemia so more aggressive interventions can be justified.
Clinical Trials:
- Underway:
- T1DES (ITN Extension Study)
- PROTECT Extension Study
- DESIGNATE (ITN siplizumab anti-CD2)
- In Startup:
- T1D RELAY: Sequential Rituximab
- Abatacept (TN-25)
- Completed:
- Sanford REPAIR-T1D
- T1GER (Golimimumab)
- EXTEND: Tocilizumab (anti-IL-6 Receptor antibody)
- ProventionBio: Teplizumab (phase 3)
- Intrexon AG019: Oral induction of tolerance (Phase 1b)
- Sanford T-Rex: Autologous Treg cells expanded ex vivo
Stage 4 (established T1D): Analog insulin and device trials for established T1D.
Clinical Trials:
- In Startup:
- GRS-2 to Sanford Chip/BioBank
- Tandem Control IQ 2.0 Pump Algorithm
- Completed:
- T1D Exchange (Registry)
- NovoNorkisk faster insulin aspart (Peds)
- Lexicon SGLT1/2 inhibitor (Adult)
- Mylan insulin glargine biosimilar (Adult)
- Medtronic Hybrid Closed Loop (2-81 y)