Cure research tracker

The only approved cell therapy for type 1 diabetes, for adults with repeated severe lows despite intensive treatment. Limited by donor supply and lifelong immunosuppression.

Rejection

Approach

Islets from deceased donors infused into the liver · Needs immunosuppression

Stage

FDA-approved (US) 2023

Latest result

In the trials behind approval, 70% were insulin-independent at one year and 34% at five years; most participants had at least one serious side effect.

Next

Offered at a small number of US centres (Chicago from 2025, Cleveland from 2026). Not available in Europe.

Checked 2026-11-11 · Sources: FDA, Lantidra · UI Health first Lantidra transplant (2025-09-04) · University Hospitals Cleveland (2026-02-24)

A faster way to make islets, about two weeks instead of five to six. The team says immunosuppression is still needed, even with the patient's own cells, because the autoimmune attack returns.

Cell supplyRejectionAutoimmunity

Approach

Islet tissue grown from endoderm stem cells, rather than fully pluripotent stem cells, infused into the liver · Needs immunosuppression

Stage

Phase 1/2a (China); US trial application reported cleared

Latest result

Three people treated, one became insulin-independent, according to institute and press reports of a March 2026 paper in The Lancet Diabetes & Endocrinology, which we have not read. Reports disagree on patient numbers.

Next

A company trial of 21 adults is recruiting, with primary completion estimated December 2027 (registry estimate).

Checked 2026-11-11 · Sources: CAS CEMCS news on E-islet results and approvals (2026-03-18) · ClinicalTrials.gov NCT07126873 · ClinicalTrials.gov NCT06196996

Tacrolimus protects transplanted islets but can harm the kidneys and the islets themselves. A gentler drug could make islet transplants safer. Patients still take lifelong anti-rejection medicine, including mycophenolic acid.

RejectionSafety

Approach

An antibody that blocks CD40L replaces tacrolimus in the anti-rejection drug mix after a donor islet transplant · Needs immunosuppression

Stage

Phase 1/2 (US, investigator-led); company registrational trial at application stage

Latest result

UChicago study, presented at ADA 2026 (company press release, not yet peer-reviewed): all 12 adults insulin-independent, median follow-up 8 months, longest 22 months, mean HbA1c about 5.4%, no rejection episodes reported. The company reports "no evidence of nephrotoxicity" but gave no kidney numbers.

Next

Company-sponsored registrational islet trial; application (IND) submitted to the FDA on 2026-09-03, start date not given (company guidance).

Checked 2026-11-11 · Sources: Eledon, updated UChicago islet data (ADA 2026) (2026-06-08) · Eledon, islet transplantation IND submission (2026-09-03) · ClinicalTrials.gov NCT06305286

Tests whether a new kind of encapsulation pouch can avoid the scarring that made earlier devices fail. The first trial is about the device, not about insulin production.

RejectionPlacement

Approach

Donor islets in a thin, soft pouch under the skin that is meant to keep immune cells out and avoid scar tissue, without gene editing

Stage

Phase 1 (Canada)

Latest result

Devices removed after about four months showed little scar tissue, blood-vessel growth and living islets; "non-fibrotic engraftment" in all seven participants (ISSCR 2026). No insulin-production data yet. Participants were people already eligible for standard islet transplants.

Next

A second phase 1 trial (upper arm or abdomen, 10 participants) is estimated to start in January 2027 (registry estimate).

Checked 2026-11-11 · Sources: ISSCR 2026 update (2026-07) · ClinicalTrials.gov NCT06408311 · ClinicalTrials.gov NCT07680673

Japan's first stem-cell islet transplant, in February 2025, testing safety of an implantable cell sheet.

Cell supplyPlacementSafety

Approach

Sheets of islet cells grown from a donor stem-cell line, implanted in the abdominal wall · Needs immunosuppression

Stage

Phase 1/1b safety study (Japan)

Next

Follow-up continues for up to five years; no efficacy results published yet.

Checked 2026-11-11 · Sources: Kyoto University Hospital announcement (2025-04-14)

In 2024 a woman in China became insulin-independent using islets grown from her own cells. A striking result, but she was already on immunosuppression after liver transplants, so it doesn't show survival without it.

Cell supplyRejection

Approach

Islets grown from stem cells made chemically from adult cells, implanted under the abdominal wall muscle sheath · Needs immunosuppression

Stage

Phase 1 (China)

Latest result

Insulin-independent from day 75; time in range rose from 43% to over 98% and HbA1c was about 5% at one year (Cell, 2024). No peer-reviewed follow-up beyond one year found.

Next

A 10-person company trial in Tianjin started in February 2025, primary completion estimated end of 2027 (registry estimate).

Checked 2026-11-11 · Sources: Wang et al., Cell 2024 (2024-09-25) · Interview with Deng Hongkui, Cell Transplantation 2025 · ClinicalTrials.gov NCT06731218

The first time transplanted islet cells have survived and made insulin in a person with type 1 diabetes without any immunosuppressive drugs. A proof of principle, not a treatment.

RejectionAutoimmunityPlacementDurability

Approach

Donor islets gene-edited to hide from the immune system (HLA class I and II removed, CD47 added), injected into forearm muscle · No immunosuppression

Stage

First-in-human study, one patient

Latest result

One adult, 37 years with T1D, received a deliberately low dose (about 7% of what insulin independence is expected to need). The cells made insulin in response to meals with no immune attack detected. At 14 months C-peptide was still comparable to the first months and the graft was visible on PET-MRI, with no safety issues (NEJM 2025; NEJM letter 2026). The patient still uses insulin, as expected at this dose.

Next

No further UP421 milestone announced; the results feed into Sana's stem-cell product SC451.

Checked 2026-11-11 · Sources: Carlsson et al., NEJM 2025 (2025-08-04) · NEJM letter, 14-month follow-up (2026-07-10) · Sana press release on 14-month data (2026-07-13) · ClinicalTrials.gov NCT06239636

Vertex's new lead cell therapy, replacing zimislecel as its focus. FDA Fast Track designation.

Cell supplyManufacturing

Approach

Stem-cell-derived islets infused into the liver, designed to work regardless of blood type · Needs immunosuppression

Stage

Phase 1/2 (dosing started 2026)

Next

Pivotal studies planned for 2027 (company guidance).

Checked 2026-11-11 · Sources: Vertex Q3 2026 results (2026-11-02) · Vertex Q2 2026 results (IND cleared) (2026-08-03)

The most advanced stem-cell islet therapy. It shows that lab-grown islets can make people insulin-independent, but it needs lifelong immunosuppression.

Cell supplyManufacturing

Approach

Fully differentiated islets grown from stem cells, infused into the liver · Needs immunosuppression

Stage

Phase 1/2/3

Latest result

Of 12 people given a full dose and followed for a year, 10 no longer needed insulin and all 12 had HbA1c under 7% with no severe lows (NEJM 2025). Two participants died, one of cryptococcal meningitis (a fungal infection, a known risk with immunosuppression) and one of progression of pre-existing dementia.

Next

Dosing was paused in 2025 for a manufacturing analysis and resumed in early 2026. In November 2026 Vertex said it will focus on the successor VX-017, because zimislecel is designed only for some blood types. No filing date is currently given for zimislecel.

Checked 2026-11-11 · Sources: Reichman et al., NEJM 2025 (2025-06-20) · Vertex Q3 2026 10-Q (2026-11-03) · ClinicalTrials.gov NCT04786262

A further stem-cell islet product with immunosuppression; FDA allowed the trial in October 2024.

Cell supplyPlacement

Approach

Stem-cell-derived islet clusters implanted in the omentum (fatty tissue in the abdomen) · Needs immunosuppression

Stage

Phase 1/2 approved, not yet recruiting

Next

Enrolment from late 2026 and first dosing in early 2027 (company guidance). The merger forming BetaNova was expected to close in late 2026.

Checked 2026-11-11 · Sources: ClinicalTrials.gov NCT07581197 · Seraxis IND allowance (2024-10-15)

The stem-cell version of the UP421 approach, meant to be made in unlimited amounts. If it works at full dose, it is the closest thing to a cure in development.

Cell supplyRejectionAutoimmunityManufacturingSafety

Approach

Islet cells grown from a universal-donor (O-negative) stem-cell line, with the same immune-hiding edits as UP421 · No immunosuppression

Stage

Trial application not yet filed

Next

Sana expects to file its application (IND) and start a phase 1/2 trial "as early as" the end of 2026 (company guidance; the same target was given a year earlier). Sana's cash is guided to last into mid-2027, and its latest quarterly report includes a going-concern warning. Mayo Clinic invested USD 25 million in April 2026.

Checked 2026-11-11 · Sources: Sana Q3 2026 results (2026-11-05) · Sana Q3 2026 10-Q (2026-11-05)

Novo Nordisk closed its own cell-therapy unit in October 2025. In January 2026 Aspect, in Vancouver, took over Novo's stem-cell islet and immune-evasion technologies, with Novo keeping a financial stake.

Cell supplyRejectionManufacturing

Approach

Stem-cell islets in bioprinted tissue, with immune-evasion engineering, designed to avoid chronic immunosuppression · No immunosuppression

Stage

Preclinical

Next

No clinical date announced.

Checked 2026-11-11 · Sources: Novo Nordisk and Aspect (2026-01-20) · BioSpace on Novo's cell-therapy exit (2025-10-13)

Another attempt at islets that need no immunosuppression, independent of Sana's technology.

Cell supplyRejection

Approach

Gene-edited, immune-evasive stem-cell islets · No immunosuppression

Stage

Preclinical

Next

Trial application (IND) planned for the second half of 2027 (company guidance).

Checked 2026-11-11 · Sources: BetaNova merger coverage (secondary) (2026-09)

Aims to protect transplanted cells locally, against both rejection and the autoimmune attack, without whole-body immunosuppression. So far the protection is short.

RejectionAutoimmunityDurability

Approach

Lab-made beta cells carry a harmless surface tag; engineered regulatory T cells recognise the tag and calm the immune system around the graft · No immunosuppression

Stage

Preclinical (mice with human immune cells)

Latest result

CAR-Tregs targeting the tag prevented immune destruction of the graft in mice (Cell Reports 2024). MUSC says protection has lasted up to about one month, the longest time tested.

Next

A USD 1 million Breakthrough T1D grant (January 2026) to make protection last longer and test repeat dosing. No date for human trials.

Checked 2026-11-11 · Sources: Barra et al., Cell Reports 2024 (2024-11) · MUSC News, Rewriting the story of type 1 diabetes research (2026-01-07)

A Swedish academic route to making islets that works across many stem-cell lines. In people, the eye has only been tried with donor islets, in people who have already lost sight in that eye.

Cell supplyManufacturingPlacementSafety

Approach

An improved recipe turns human stem cells into islets; separately, the front chamber of the eye is tested as a place for islets, where they can be watched directly · Needs immunosuppression

Stage

Preclinical (mice) for the stem-cell islets; donor-islet eye trial phase 1/2 (US)

Latest result

Functional islets from all 8 stem-cell lines tested (4 embryonic, 4 iPS); letting the cells clump on their own removed dividing and non-islet cells, and islets placed in the eye restored normal blood sugar in diabetic mice (Stem Cell Reports 2026).

Next

The Miami eye trial (2 participants, eye-drop immunosuppression) is recruiting, with primary completion estimated December 2026 (registry estimate). No commercial partner is driving the stem-cell islets toward the clinic.

Checked 2026-11-11 · Sources: Wu et al., Stem Cell Reports 2026 (2026-04-16) · KI News, Progress in stem cell therapy for type 1 diabetes (2026-04-16) · Nordic Life Science, Restoring glucose regulation through the eye (2026-04-01) · ClinicalTrials.gov NCT02846571

The trial ended with five participants; no results published. CRISPR's diabetes work has moved to CTX213, a device-free product that is still preclinical.

RejectionPlacement

Approach

Gene-edited stem-cell-derived cells in an implanted device · No immunosuppression

Stage

Phase 1, terminated

Checked 2026-11-11 · Sources: ClinicalTrials.gov NCT05565248 · CRISPR Therapeutics Q3 2026 10-Q (2026-11-02)

Safe, but did not produce enough insulin. Encapsulation alone has not yet worked well enough in people.

RejectionPlacement

Approach

Zimislecel cells inside an implanted protective device, without immunosuppression · No immunosuppression

Stage

Phase 1/2, discontinued March 2025

Checked 2026-11-11 · Sources: Vertex 2025 10-K (2026-02-13)

No new cells are added, so there is nothing for the immune system to reject or attack. Whether muscle can control blood sugar safely in people is unknown.

Cell supplyRejectionAutoimmunitySafety

Approach

A one-time injection into muscle of viral vectors (AAV) carrying genes for insulin and glucokinase, a glucose sensor, so muscle can lower blood sugar · No immunosuppression

Stage

Phase 1/2 (Australia; a sister trial in Canada and New Zealand)

Latest result

Animal data only; the company reports effects lasting up to four years after one treatment (not peer-reviewed).

Next

PROGRESS (29 adults with T1D for at least 5 years, already on automated insulin delivery) and the glucokinase-only RELIEVE trial are recruiting, with estimated start October 2026 and primary completion July 2029 (registry estimates). No dosing has been announced.

Checked 2026-11-11 · Sources: ClinicalTrials.gov NCT07829302 (PROGRESS) · ClinicalTrials.gov NCT07831798 (RELIEVE) · Diabetes UK on gene therapy and islet advances (2026-04-13)

The first drug shown to delay type 1 diabetes. It's given at stage 2, when autoantibodies and abnormal glucose are present but before symptoms, so it only reaches people found by screening.

AutoimmunityChildren

Approach

An antibody infusion (anti-CD3) over 14 days that changes how T cells behave, slowing their attack on beta cells

Stage

Approved in the US (2022), UK (2025) and EU (January 2026)

Latest result

In the TN-10 trial (76 people at stage 2), the median time to clinical diagnosis was about 4 years with teplizumab vs 2 years with placebo. In newly diagnosed children (PROTECT, NEJM 2023) it preserved more of their own insulin production, but without a difference in insulin dose or HbA1c. In 2026 the US label was widened to stage 2 from age 1, and (accelerated approval) to recently diagnosed children aged 8–17.

Next

In Sweden, the national NT council advised regions in March 2026 to wait while TLV assesses cost-effectiveness; no date given. A phase 3 trial in recently diagnosed people aged 1–25 (BETA-PRESERVE) runs to about 2028 (registry estimate), with no Swedish site.

Checked 2026-11-11 · Sources: EMA, Teizeild · Sanofi, EU approval (2026-01-12) · FDA, stage 3 approval for children (2026-06-12) · NT-rådet / Samverkan läkemedel, Teizeild (2026-03-20) · NICE TA1176 (2026-07-09)

A tablet that preserved insulin production in newly diagnosed young people. The effect faded after treatment stopped, so it may need to be taken continuously.

AutoimmunityChildren

Approach

A daily tablet (JAK inhibitor, approved for rheumatoid arthritis) that blocks the signals immune cells use to attack beta cells

Stage

Phase 3

Latest result

In BANDIT (91 people aged 10–30, NEJM 2023), own insulin production after 48 weeks was clearly higher than with placebo and insulin needs were lower. After stopping, the benefit was gone by week 96 (Diabetes Care 2026).

Next

Two Lilly phase 3 trials started in 2026, both with Swedish sites. BARICADE-PRESERVE (newly diagnosed, ages 1–35) completes around mid-2028; BARICADE-DELAY (stage 1b–2) around 2031 (registry estimates).

Checked 2026-11-11 · Sources: Waibel et al., NEJM 2023 (BANDIT) (2023-12) · WEHI, off-treatment follow-up (2026) · ClinicalTrials.gov NCT07222332 · ClinicalTrials.gov NCT07222137

Evidence from outside type 1 diabetes: the strongest sign yet that an immune "reset" can stop an autoimmune disease without ongoing drugs. Type 1 diabetes is driven mainly by T cells, so it's unclear whether a B-cell reset would work.

AutoimmunitySafetyDurability

Approach

A patient's own T cells are engineered to wipe out B cells after chemotherapy, so the immune system rebuilds without the autoimmunity

Stage

Phase 1/2 (Germany) in lupus, systemic sclerosis and myositis; not tested in type 1 diabetes

Latest result

CASTLE trial (Nature Medicine 2026, 24 patients): 9 of 10 with lupus in remission, all off steroids and other immune drugs at 24 weeks; required chemotherapy. An older precedent in type 1 diabetes: after stem-cell transplantation with chemotherapy, 20 of 23 people aged 13–31 became insulin-free for a time (JAMA 2009).

Next

Investigators say the results support a pivotal trial; no date given.

Checked 2026-11-11 · Sources: CASTLE trial, Nature Medicine 2026 (2026-01-07) · Couri et al., JAMA 2009 (2009-04-15)

One of the first CAR-T tests in type 1 diabetes itself. CD7 is on most T cells, so this is a strong intervention with infection risk, limited to small safety studies.

AutoimmunitySafety

Approach

Donor T cells engineered to kill cells carrying CD7, given as one drip to reset the T-cell side of the immune system

Stage

Early phase 1 (China), two small studies of the same product

Next

Bioheng's pilot (3 people, chemotherapy before the infusion) has finished recruiting with no results posted. Zhongshan's study (up to 9 adults aged 18–40, stage 2–3) is recruiting, primary completion estimated December 2027 (registry estimate).

Checked 2026-11-11 · Sources: ClinicalTrials.gov NCT07142161 · ClinicalTrials.gov NCT07528105

One of the larger new-onset immune trials, with Swedish sites. No results yet.

Autoimmunity

Approach

An antibody that blocks CD40L, a signal T cells need to drive an immune attack

Stage

Phase 2 (FABULINUS), fully enrolled

Next

Primary completion estimated April 2027 (registry estimate).

Checked 2026-11-11 · Sources: ClinicalTrials.gov NCT06111586

The first engineered regulatory T-cell therapy for type 1 diabetes in people, in adults recently diagnosed. Several other T-cell therapy companies have not reached human trials in type 1 diabetes.

Autoimmunity

Approach

The patient's own regulatory T cells, engineered to calm the immune attack where it happens

Stage

Phase 1 (US)

Next

First data planned for late 2026 to early 2027 (company guidance).

Checked 2026-11-11 · Sources: GentiBio, first participant dosed (2026-03-18) · ClinicalTrials.gov NCT06919354

An old transplant drug that, at a low dose, preserves insulin production in newly diagnosed people. A very low dose worked about as well with fewer side effects.

AutoimmunityChildren

Approach

A short infusion of antibodies that briefly depletes and resets T cells

Stage

Phase 2 results; head-to-head and phase 2b trials running

Latest result

In MELD-ATG (ages 5–25, 8 European countries, Lancet 2025), 0.5 mg/kg preserved insulin production about as well as 2.5 mg/kg, with less serum sickness (32% vs 82%).

Next

TrialNet compares teplizumab with low-dose ATG at stage 2 (from 2026, to 2029). SAB-142, a fully human version, is in a phase 2b with results expected in 2027 (registry estimate). Not approved for type 1 diabetes anywhere.

Checked 2026-11-11 · Sources: MELD-ATG, Lancet 2025 (2025-09-18) · Cambridge MRL on MELD-ATG (2025-09-23) · ClinicalTrials.gov NCT07216391 (TN-40A) · ClinicalTrials.gov NCT07187531 (SAB-142)

A small safety study that includes children from age 8. Earlier regulatory T-cell trials elsewhere were safe but showed limited lasting benefit.

AutoimmunityChildren

Approach

A patient's own regulatory T cells, multiplied in the lab and given back, compared with routine care · No immunosuppression

Stage

Phase 1 (China), ages 8–65

Next

20 participants, not randomised; primary completion estimated December 2026 (registry estimate; registry not updated since November 2024).

Checked 2026-11-11 · Sources: ClinicalTrials.gov NCT06708780

The most concrete Swedish trial for newly diagnosed children. Its 12-month result was negative overall, and the company now focuses on adults.

AutoimmunityChildren

Approach

A single drip of donor umbilical-cord stromal cells (MSCs) soon after diagnosis, to calm the immune attack · No immunosuppression

Stage

Phase 1/2 in children and young people aged 7–21 (Sweden), reported 2026

Latest result

ProTrans-Young, 12 months (company release, October 2026): primary goal not met. In ages 7–11 more kept their own insulin production than with placebo, but the difference was not significant and data were missing for some children. In adults (10 treated vs 5 placebo, Diabetologia 2023) there was less loss at one year.

Next

24-month results for ages 12–21 when analyses are complete; no date (company guidance).

Checked 2026-11-11 · Sources: NextCell, results in children and adult strategy (2026-10-26) · ClinicalTrials.gov NCT05061030 · Carlsson et al., Diabetologia 2023 (2023-05-24)

One of few cell-therapy trials in young children, aimed at the presymptomatic stage. Some groups also get rituximab, an antibody that removes B cells and suppresses part of the immune system for months.

AutoimmunityChildren

Approach

A child's own regulatory T cells, multiplied in the lab and given back, alone or with rituximab, before symptoms start

Stage

Phase 2 (Poland), children aged 3–18 at stage 1

Next

150 children; recruiting, completion estimated December 2032 (registry estimate).

Checked 2026-11-11 · Sources: ClinicalTrials.gov NCT06688331

Cheap and widely available, with some evidence it preserves insulin production. Not recommended for type 1 diabetes by any society, and the adult trial narrowly missed its main goal.

AutoimmunityChildren

Approach

An old blood-pressure tablet that appears to protect beta cells directly, by lowering the stress protein TXNIP

Stage

Phase 2/3 results; not recommended by guidelines

Latest result

In CLVer (88 children, JAMA 2023) own insulin production was about 30% higher after a year. In the European adult trial Ver-A-T1D (presented 2025) the primary endpoint narrowly missed significance; no paper yet.

Next

Combination trials (with ATG or other drugs) are running.

Checked 2026-11-11 · Sources: Forlenza et al., JAMA 2023 (CLVer) (2023-03) · Ver-A-T1D results (EurekAlert) (2025-09-18)

An early human test of engineered regulatory T cells in type 1 diabetes, in six adults aged 18–35.

AutoimmunitySafety

Approach

A patient's own regulatory T cells are fitted with a receptor against CD6 and given back, to calm the attack on beta cells · No immunosuppression

Stage

Early phase 1 (US), not yet recruiting

Next

Estimated start November 2026, primary completion February 2028 (registry estimate).

Checked 2026-11-11 · Sources: ClinicalTrials.gov NCT07395050

Preserved insulin production in newly diagnosed children (T1GER, NEJM 2020). Now being tested earlier, in stage 1, to see if it can stop progression.

AutoimmunityChildren

Approach

An anti-TNF injection (approved for other autoimmune diseases)

Stage

Stage 1 prevention trial planned

Next

A US prevention trial in ages 2–44 (about 255 people) was due to start in 2026 and runs to about 2032 (registry estimate).

Checked 2026-11-11 · Sources: Quattrin et al., NEJM 2020 (T1GER) (2020-11) · ClinicalTrials.gov NCT07683026

Could make an immune reset simpler and possibly gentler, perhaps without chemotherapy, which would matter for children. We found no registered trial in type 1 diabetes.

AutoimmunityManufacturingSafetyChildren

Approach

Fat particles or viral vectors deliver the CAR gene straight to T cells in the bloodstream, so no cells are made in a lab

Stage

Preclinical for type 1 diabetes; first small human studies in lupus

Latest result

In a first report of five people with severe lupus, given mRNA-based CAR-T without chemotherapy, disease activity fell at three months (NEJM letter, 2025).

Checked 2026-11-11 · Sources: In vivo CD19 CAR-T in lupus, NEJM 2025 (2025-09-17) · In vivo CAR-T review, Nature Reviews Drug Discovery 2025 (2025-09-30)

The Swedish phase 3 hope. The interim analysis in March 2026 found no effect on insulin production, overall or in any planned subgroup, and the company discontinued the trial in April 2026.

Autoimmunity

Approach

An "antigen-specific vaccine" injected into a lymph node, meant to retrain the immune system in people with a specific gene type (HLA DR3-DQ2)

Stage

Phase 3 (DIAGNODE-3), discontinued for futility April 2026

Latest result

No treatment effect on C-peptide at 15 months in 174 of 321 participants analysed; no safety concerns.

Checked 2026-11-11 · Sources: Diamyd, negative interim results (2026-03-27) · Diamyd, interim update (2026-03-29) · Diamyd, DIAGNODE-3 discontinued (2026-04-10) · ClinicalTrials.gov NCT05018585

In 220 young children with stage 1 type 1 diabetes, a year of oral insulin did not slow progression. 40% progressed within five years in both groups (Diabetes Care 2026).

AutoimmunityChildren

Approach

High-dose insulin taken by mouth, to teach the immune system to tolerate insulin

Stage

Prevention trial, negative

Checked 2026-11-11 · Sources: Fr1da oral insulin trial, Diabetes Care 2026 (2026-05)

Europe's large screening effort. Over 100,000 children tested by March 2026. Swedish data are part of it.

Children

Approach

Screening of about 220,000 children across Europe, with shared follow-up

Stage

Research programme, 2023–2028

Latest result

Among children without a family history, 0.22% (Germany) to 0.47% (Sweden) had early-stage type 1 diabetes; 2.1% of children with an affected parent or sibling did (EASD 2026).

Checked 2026-11-11 · Sources: TU Dresden, 100,000 screened (2026-03-16) · EASD 2026 data (Managed Healthcare Executive) (2026-10-21) · CORDIS, EDENT1FI

The longest-running general-population screening. It shows screening finds most future cases, not just those with a family history.

Children

Approach

Autoantibody screening of all children at routine check-ups in Bavaria

Stage

Population programme since 2015

Latest result

Of 220,476 children screened, 0.3% had early-stage type 1 diabetes; 36% of them progressed to clinical diabetes within five years, at the same rate with or without a family history (JAMA 2026).

Checked 2026-11-11 · Sources: Fr1da, JAMA 2026 (News-Medical summary) (2026-05-21) · Fr1da, JAMA 2020 (2020)

The American Diabetes Association recommends screening relatives and others at known risk. An international consensus endorsed by 20 organisations (including EASD, ISPAD and IDF Europe) went further in September 2026 and recommended screening all children.

Children

Approach

A blood test for four islet autoantibodies (insulin, GAD, IA-2, ZnT8), which appear years before symptoms

Stage

Guideline

Latest result

The consensus suggests a first test at age 2–4, and again at 6–8 and 10–15 if negative. Children found early and followed up rarely have diabetic ketoacidosis (DKA) at diagnosis, which otherwise affects 20–67% of children.

Checked 2026-11-11 · Sources: ADA Standards of Care 2026, section 2 (2025-12-08) · International consensus (EurekAlert) (2026-09-10)

Sweden has no national screening programme. Most screening happens in research studies run from Lund. Swedish paediatricians drafted national follow-up algorithms for autoantibody-positive children in 2025.

Children

Approach

Research screening (TEDDY, TRIAD home-kit screening, DiaUnion) mainly in Skåne; no national programme

Stage

Research only

Next

Whether the SFPED follow-up guidance has been published, and whether teplizumab is introduced in Swedish regions after TLV's assessment.

Checked 2026-11-11 · Sources: SFPED, follow-up of autoantibody-positive children (slides) (2025-11-14) · Lund University on children's blood samples · Dagens Diabetes on TRIAD

Parents could see rising ketones early, during illness or a pump failure, without finger-prick ketone tests. The 10-day version is approved from age 2 in both the EU and the US.

Children

Approach

One sensor that measures both glucose and ketones

Stage

CE-marked May 2026 (Libre Duo 18+, 15 days; Libre Duo 10 Day from age 2); FDA August 2026 (10 Day, from age 2)

Next

Launch in selected European countries later in 2026. US pump integrations from late 2026, with Tandem and others in 2027 (company guidance).

Checked 2026-11-11 · Sources: Abbott, CE mark for dual glucose-ketone sensing (2026-05-27) · Breakthrough T1D on US approval (2026-08-26)

Children on injections can replace mealtime shots with an inhaler, but still need basal insulin. It doesn't work with a pump.

Children

Approach

Fast-acting insulin powder breathed in at meals instead of injected

Stage

On sale in the US; FDA approved for children 6+ in May 2026; not approved in the EU

Latest result

In INHALE-1 (230 children aged 4–17, 26 weeks), HbA1c just missed the non-inferiority margin in the full analysis and met it after one non-adherent patient was excluded (MannKind, 2024).

Checked 2026-11-11 · Sources: MannKind Form 8-K, FDA approval ages 6+ (2026-05-29) · INHALE-1 topline (Contemporary Pediatrics) (2024-12-20)

No carb counting or dose settings, which can lower the daily workload for families. Cleared from age 6.

Children

Approach

A pump that makes all dosing decisions from body weight and CGM; at meals the user only says whether the meal is smaller, usual or larger

Stage

On sale in the US (age 6+); not approved in the EU or UK

Checked 2026-11-11 · Sources: FDA 510(k) K253976, iLet ACE Pump (2026-04-30)

Removes carb counting and pre-meal boluses for teenagers and adults. Indicated from age 13 and not in pregnancy; younger children stay on hybrid CamAPS FX.

Children

Approach

A mode in the CamAPS FX app that runs the pump with no carb counting and no meal boluses

Stage

CE-marked January 2026; launching in Europe from September 2026

Next

Launched in Germany, Austria and Switzerland (September 2026) and Italy (October 2026); no Swedish date announced (company guidance).

Checked 2026-11-11 · Sources: CamDiab and mylife launch (2026-09-01) · CamAPS Liberty product page

The 15-day sensor means fewer sensor changes, but it is cleared only for adults, so children stay on the standard 10-day G7. G6 is being phased out.

Children

Approach

Continuous glucose sensors; G7 15 Day lasts longer than G7, and G8 is a smaller next-generation sensor

Stage

G7 15 Day: FDA 2025 (adults); no EU CE mark found. G8: in development

Latest result

G7 15 Day accuracy (MARD) 8.0% (FDA clearance, April 2025). G8 is about half the size of G7 (Investor Day, May 2026).

Next

G8 FDA submission in 2027, launch late 2027 or early 2028; ketone sensing after the first G8 release (company guidance).

Checked 2026-11-11 · Sources: FDA clears Dexcom 15-day CGM for adults (Healio) (2025-04-10) · Dexcom unveils G8 (HLTH) (2026-05-15)

In a large Dutch trial in adults the benefit was small and there were more severe lows than with usual care. The Dutch reimbursement authority said no in September 2026.

Approach

A fully automatic pump that gives insulin to lower glucose and glucagon to raise it, with no meal input

Stage

CE-marked in the EU since 2020; not reimbursed in the Netherlands from 2026

Latest result

DARE trial (243 adults, 12 months, EASD 2026): people switching from injections plus CGM went from 60.8% to 64.8% time in range, with no difference compared with hybrid closed loop; 9 severe lows vs 2 with usual care; about half stopped using the device.

Checked 2026-11-11 · Sources: Diabetes.nl: results of the DARE study (2026-10-02) · DVN: Zorginstituut Nederland decision (2026-09-29)

Another automated pump for US families, cleared from age 6. A second algorithm, Diabeloop DBLG2, is being added; it makes meal announcements optional and is cleared from age 12.

Children

Approach

A tubed pump that measures each micro-dose it delivers, running the Tidepool Loop algorithm

Stage

On sale in the US (age 6+); not available outside the US

Next

twiist with DBLG2 ready by the end of 2026, US launch in 2027 (company guidance).

Checked 2026-11-11 · Sources: Diabeloop and Sequel partnership (2026-01-14)

A smaller pump that's easier to wear. In Europe it launched with the Dexcom G7 and works only with a compatible iPhone. No real-time follow app for caregivers (see the blog).

Approach

A very small tubed insulin pump run from a phone app, with an algorithm that adjusts insulin every five minutes from CGM readings

Stage

On sale in the US; launched in 12 more countries including Sweden (September 2026)

Next

Android support and more sensors in selected countries in 2027. In the US, a tubeless Mobi with FDA decision expected late 2026 and full availability in the first half of 2027; a 7-day infusion set after that (company guidance).

Checked 2026-11-11 · Sources: Tandem Mobi in twelve international markets (2026-09-28) · Tandem Q3 2026 earnings call transcript (2026-11-05)

Aims at fewer lows with the same HbA1c, for people on injections. Tested only in adults so far.

Approach

Ordinary mealtime insulin packed in tiny fat bubbles that steer part of it to the liver; it does not respond to glucose

Stage

Phase 2b completed (US); phase 3 planned

Latest result

OPTI-2 (226 adults on injections, 25 weeks, ADA 2026, company release): HbA1c as good as standard lispro; in the maintenance period, 28% fewer events below 3.0 mmol/L over 24 hours. The main superiority test was narrowly missed. Severe lows 0 vs 5, not statistically significant.

Next

Phase 3 planned, no start date (company guidance).

Checked 2026-11-11 · Sources: Diasome, phase 2b data (press release) (2026-06-07) · ClinicalTrials.gov NCT06238778

A pill could replace some injections. This first human study only checks the safety of single doses in 12 healthy adults; it can't yet show whether the pill controls blood sugar in type 1 diabetes.

Approach

An insulin pill; the insulin rides on tiny particles meant to survive the gut and reach the liver first, as the body's own insulin does

Stage

Phase 1a (Australia), healthy volunteers

Latest result

In diabetic mice and rats it lowered glucose without causing lows (Nature Nanotechnology, 2024). The phase 1a trial was fully enrolled in September 2026.

Next

Last data collection November 2026 (registry estimate); a phase 1b in people with type 1 diabetes is planned, with no date (company guidance).

Checked 2026-11-11 · Sources: ANZCTR ACTRN12626000827336 (2026-11-10) · University of Sydney, oral insulin milestone (2026-09-10) · Oral nanotherapeutic insulin, Nature Nanotechnology 2024 (2024-01)

Aims at better control for people who miss or skip meal boluses. The pivotal trial included children from age 2.

Children

Approach

A tubeless pod with a new algorithm that learns each person's insulin needs and works with more CGM brands

Stage

Pivotal trial completed (US); FDA filing 2026

Latest result

STRIVE (132 people, crossover, ADA 2026, company release); in type 1 aged 14 and over, time in range 77% vs 73% on Omnipod 5, no severe lows or DKA. Results for younger children not given.

Next

US launch in 2027 (company guidance).

Checked 2026-11-11 · Sources: Insulet, Omnipod 6 data (2026-06-08)

Same goal as Novo's, fewer lows and less dose adjustment. Lilly has not published data or named a trial for this program since buying Protomer in 2021.

Approach

An insulin engineered with a protein sensor so that its activity follows blood sugar

Stage

Preclinical (no clinical trial disclosed)

Checked 2026-11-11 · Sources: Lilly announces acquisition of Protomer Technologies (2021-07-14)

If it works in people, it could lower the risk of lows, especially at night, without giving up control. So far it has only been tested in rats and pigs. An earlier Novo glucose-sensitive insulin, a different molecule, finished two small phase 1 trials in 2021–2022 with no results posted.

Approach

An insulin with a built-in chemical switch that makes it more active when blood sugar is high and less active when it is low

Stage

Preclinical (animal studies)

Latest result

Receptor binding rose 3.2-fold as glucose went from 3 to 20 mmol/L; in animals it protected against lows while partly covering glucose rises (Nature, 2024).

Checked 2026-11-11 · Sources: Glucose-sensitive insulin with attenuation of hypoglycaemia, Nature 2024 (2024-10-16) · ClinicalTrials.gov NCT05134987 (NNC0363-0845, completed)

Could one day mean fewer doses and fewer lows. All published work is in mice and pigs; no human trial found.

Approach

Lab projects, including a microneedle skin patch and an injectable weekly depot, that release insulin when glucose rises

Stage

Preclinical (animal studies)

Latest result

A coin-sized patch controlled glucose for about 20 hours in diabetic pigs (2020); an injectable gave up to a week of stable glucose in diabetic pigs (reported 2026).

Checked 2026-11-11 · Sources: UCLA, smart insulin patch (2020-02-03) · Zhejiang University news (2026-04-10)