Type 1 Diabetes: Independent Evidence on Insulin, Tech & Cures

Table of contents

• Evidence summary
• What type 1 diabetes is
• Symptoms, diagnosis and red flags
• Causes and risk factors
• Treatments that work
• Medicines and cell therapies
• Supplements and lifestyle claims
• Risks of common treatments
• Who to see
• Follow the money: who funds the research and who profits
• Related research
• Frequently asked questions
• Sources and funding notes

Evidence summary

Independent evidence and credibility scorecard

Independence tiers: 1 = regulator or government body; 2 = academic or publicly funded team with no declared commercial funding for the work; 3 = publicly or charity-funded work with declared industry involvement (donated product, manuscript review) or an advocacy funder; 4 = manufacturer-funded or manufacturer-authored. Credibility runs from A (highest) to D.

Most of these sources come from the US and UK. The verdict therefore reflects two rich health systems with very different payment models. Access and prices look very different in low-income countries, where the same JDRF-funded model estimated a 10-year-old diagnosed in 2021 could expect on average 13 more years of life, against 65 years in high-income countries (Gregory 2022). Where opposing interests converge, confidence rises. NICE, which must justify NHS spending, reached the same conclusion on closed-loop systems as the device makers' own trials. On teplizumab, a government-run trial and the company-run trial both found a biological effect, but only the government trial showed a delay in diagnosis.

What type 1 diabetes is

Type 1 diabetes happens when the immune system destroys the beta cells in the pancreas that make insulin. Without insulin, glucose cannot enter the body's cells and builds up in the blood. Most people need insulin every day to stay alive (NIDDK). It is a different disease from type 2 diabetes, which is driven mainly by insulin resistance. Our type 2 diabetes guide covers that separately.

In the US, about 1.7 million adults and 304,000 children and teenagers had type 1 diabetes in 2021. It makes up 5% to 10% of all diabetes (NIDDK). Worldwide, a modelling study funded by the charity JDRF estimated 8.4 million cases in 2021 (95% uncertainty interval 8.1 to 8.8 million). It estimated that 64% were aged 20 to 59 and that the median age at onset was 39 (Gregory 2022). The same model estimated that about 35,000 people died within a year of symptoms starting without ever being diagnosed. It projected 13.5 to 17.4 million cases by 2040.

The three stages

Type 1 diabetes starts years before symptoms. A 2015 statement from JDRF, the Endocrine Society and the American Diabetes Association defined three stages (Insel 2015):

• Stage 1: two or more islet autoantibodies in the blood, with normal blood glucose and no symptoms.
• Stage 2: autoantibodies plus abnormal glucose tests ("dysglycaemia"), still with no symptoms.
• Stage 3: symptomatic disease, which is when most people are diagnosed.

This staging matters because teplizumab is licensed for stage 2. The statement says the staging was designed partly to support regulatory approval and reimbursement of early treatments. That is a reasonable scientific aim, but it also served the interests of the charities that wrote it and of companies developing such drugs.

Symptoms, diagnosis and red flags

The NHS sums up the common symptoms as the "4 Ts": toilet (peeing more, especially at night, or bed-wetting and heavier nappies in children), thirsty, tired and thinner (losing weight without trying). Other signs include blurred vision, fruity or "pear drop" breath, slow-healing cuts and repeated infections such as thrush. Symptoms usually come on over days or weeks (NHS).

Red flags: diabetic ketoacidosis (DKA)

DKA happens when a lack of insulin makes the body burn fat for fuel, producing acidic ketones. Symptoms include thirst, frequent peeing, tummy pain, nausea or vomiting, diarrhoea, deeper breathing, fruity breath, blurred vision, and sleepiness or confusion. They usually develop over 24 hours but can be faster. DKA can be the first sign of type 1 diabetes, particularly in children (NHS).

The NHS gives these blood ketone guide levels: under 0.6 mmol/L is normal; 0.6 to 1.5 is slightly high (retest in 2 hours); 1.6 to 3 means a risk of DKA (contact the diabetes team); over 3 means possible DKA (call 999 or go to A&E). It also says not to drive yourself to A&E (NHS). NICE advises ketone monitoring as part of "sick-day rules" and hospital treatment with intravenous fluids and an insulin infusion (NICE NG17 1.10).

How it is diagnosed

In adults, NICE says to make the first diagnosis on clinical grounds. Typical features include ketosis, rapid weight loss, onset under 50, a BMI below 25 and a personal or family history of autoimmune disease. Age or BMI alone should not be used to rule type 1 in or out. NICE advises measuring diabetes-specific autoantibodies at diagnosis, ideally testing for two types, and not routinely measuring C-peptide to confirm the diagnosis (NICE NG17 1.1). Adults are sometimes wrongly labelled as having type 2 diabetes, which is why NICE says to revisit the diagnosis at later reviews.

Autoantibody screening can find stage 1 and stage 2 disease in people without symptoms, especially relatives of people with type 1 diabetes (NIDDK). The UK has no national screening programme. NICE's teplizumab committee noted that one is unlikely soon, and that how people are found affects whether the drug is good value (NICE TA1176).

Causes and risk factors

Type 1 diabetes is caused by autoimmune destruction of beta cells, triggered by a mix of genes and environmental factors that are still not fully understood. US government-funded studies such as TEDDY are trying to identify the triggers (NIDDK). Known risk factors:

• Family history: having a parent or sibling with type 1 diabetes raises the risk (NIDDK).
• Other autoimmune conditions in the person or their family (NHS). Coeliac disease and thyroid disease are common companions; see our coeliac disease review.
• Age: commonest in children and young adults, but it can develop at any age (NIDDK).

Type 1 diabetes is not caused by eating sugar or by being overweight, and nothing a parent did causes it. Claims that a specific diet, vaccine schedule or supplement "causes" or "prevents" it are not supported by trial evidence. The observational vitamin D signal is discussed below.

Treatments that work

Insulin regimens: basal–bolus as the default

Healthy pancreases release a small steady trickle of insulin, plus bursts at meals. Basal–bolus regimens copy that: a long-acting "basal" insulin once or twice a day, plus rapid-acting "bolus" doses with meals and to correct highs. NICE recommends multiple daily injection basal–bolus as the injection regimen of choice for all adults (NICE NG17 1.7.1). Its preferred basal insulin since 2021 has been twice-daily insulin detemir (Levemir). Novo Nordisk is discontinuing Levemir, with supply expected to end in December 2026, and NICE is assessing what that means for its advice (NICE NG17). A company's commercial decision is therefore reshaping a national recommendation. People currently on Levemir should expect their team to discuss a switch.

The evidence that good glucose control matters comes mainly from the DCCT. In this publicly funded trial, 1,441 people were randomised to intensive therapy (pump or three or more daily injections, with frequent glucose checks) or the then-standard one or two injections a day. Intensive therapy cut the risk of developing retinopathy by 76% and slowed its progression by 54%. It also reduced kidney damage markers and clinical neuropathy (DCCT 1993). The main cost was a two- to three-fold increase in severe hypoglycaemia.

Structured education

Insulin dosing depends on food, activity, illness and stress, so self-management skills are a treatment in themselves. NICE says to offer every adult a structured education programme "of proven benefit", such as DAFNE (Dose Adjustment For Normal Eating), 6 to 12 months after diagnosis. It also recommends Blood Glucose Awareness Training for people with recurrent hypos (NICE NG17 1.3).

Glucose monitoring: finger-pricks, flash and CGM

Since 2022, NICE has advised offering all adults with type 1 diabetes a choice of real-time CGM or intermittently scanned ("flash") CGM. If several devices meet a person's needs, NICE advises choosing the cheapest (NICE NG17 1.6.10–1.6.11). The best-known US trial in injection users, DIAMOND, found HbA1c fell 0.6 percentage points more with CGM than with usual care over 24 weeks. Time spent below 70 mg/dL (3.9 mmol/L) fell from a median of 80 to 43 minutes a day (Beck 2017). DexCom, which made the sensors, was the lead sponsor (ClinicalTrials.gov). The direction of benefit is consistent with NICE's independent review, so we grade it moderate to strong. The exact size of the effect in everyday use is less certain.

Insulin pumps and hybrid closed loop

Pumps deliver rapid-acting insulin continuously through a cannula under the skin. NICE's older appraisal reserves pumps (without automation) for people 12 and over who have disabling hypoglycaemia or an HbA1c of 69 mmol/mol (8.5%) or above despite careful injection therapy (NICE TA151).

Hybrid closed loop (HCL) systems link a pump to a CGM through an algorithm that adjusts insulin automatically. People still enter meal doses, which is why the loop is "hybrid". In December 2023, NICE recommended HCL for (NICE TA943):

• adults with an HbA1c of 58 mmol/mol (7.5%) or above, or disabling hypoglycaemia, despite best use of a pump or CGM;
• all children and young people;
• people who are pregnant or planning pregnancy.

The recommendation applies only at a cost-effective price agreed between the companies and NHS England, with a five-year phased rollout. NICE's committee noted that over 65% of people with type 1 diabetes in the National Diabetes Audit have an HbA1c above 58 mmol/mol (NICE TA943).

How big is the benefit? In the NIDDK-funded iDCL trial of 168 people, a closed-loop system raised time in range (3.9 to 10.0 mmol/L) from 61% to 71%. The sensor-augmented pump group stayed at 59%, an adjusted difference of 11 percentage points. HbA1c fell 0.33 points more, and time below 3.9 mmol/L fell slightly. No severe hypos occurred; there was one DKA episode in the closed-loop group (Brown 2019). Tandem Diabetes Care supplied the systems and reviewed the manuscript but did not run the trial (full text). NICE's independent assessors pooled the randomised trials and found a smaller HbA1c fall of 3.1 mmol/mol (0.29 points) against pump plus CGM. An NHS England pilot in people with a higher starting HbA1c (around 79 mmol/mol) reported a fall of 16.2 mmol/mol (1.5 points). NICE judged the true NHS effect to be probably larger than the trials suggested, but "highly uncertain" (NICE TA943).

Hypoglycaemia awareness

After years of diabetes, some people lose the warning signs of a low glucose, such as shaking, sweating and hunger. This "impaired awareness" greatly raises the risk of severe hypos. NICE advises checking awareness every year with the Gold or Clarke score. It recommends structured education, avoiding hypos, and then technology or transplant referral if severe hypos continue (NICE NG17 1.9, 1.8.1). CGM alarms and closed-loop systems are now central to this, as the TA943 criteria show.

Medicines and cell therapies

Insulin types

Modern care mainly uses analogue insulins: rapid-acting (such as lispro, aspart and glulisine) for meals, and long-acting (such as glargine, degludec and detemir) for basal cover. NICE lists glargine and degludec as alternatives to detemir (NICE NG17 1.7.4). WHO notes that analogues cost at least 1.5 times as much as older human insulins, and three times as much in some countries (WHO).

Teplizumab (Tzield): delaying diagnosis

Teplizumab is an anti-CD3 antibody given as a 14-day intravenous infusion. It is thought to dampen the T cells that attack beta cells. The FDA approved it on 17 November 2022 to delay stage 3 diabetes in people aged 8 and over with stage 2 disease (AJMC). The approval rested largely on the TrialNet TN-10 trial. Among 76 high-risk relatives, 43% on teplizumab and 72% on placebo were diagnosed during follow-up. The median time to diagnosis was 48.4 vs 24.4 months, a hazard ratio of 0.41 (0.22 to 0.78). Rash and temporary lymphopenia (low white cells) were expected side effects (Herold 2019).

Since then:

• UK: the MHRA approved it on 14 August 2025. It said the drug delays stage 3 by an average of three years (MHRA). NICE recommended it for NHS use on 9 July 2026, at a confidential discount (NICE TA1176). The list price is £10,939.12 per 2-mg vial (NICE).
• US: the June 2026 label extends the stage 2 use to children from age 1. It adds an accelerated-approval use for children aged 8 to 17 with recently diagnosed stage 3 diabetes, based on slower C-peptide decline. It also adds a boxed warning on viral reactivation (FDA label).

The new-onset evidence comes from PROTECT, funded by Provention Bio and Sanofi. In 328 children and teenagers, teplizumab preserved more C-peptide (a marker of the body's own insulin) at 78 weeks. However, it made no significant difference to insulin dose, HbA1c, time in range or hypoglycaemia (Ramos 2023). An accelerated approval means continued approval may depend on proof of clinical benefit. That is exactly what the secondary outcomes did not show.

Other immune drugs in trials

Several existing medicines have slowed beta-cell loss in small trials. None is approved for this use.

• Verapamil (a blood pressure drug): in 88 newly diagnosed children, C-peptide was 30% higher at 52 weeks than with placebo, but HbA1c did not differ significantly. The trial was funded by NIDDK grants (Forlenza 2023). A companion trial found that very tight glucose control with automated insulin delivery did not slow C-peptide decline (McVean 2023).
• Baricitinib (a JAK inhibitor for arthritis): in 91 people within 100 days of diagnosis, it preserved more C-peptide at 48 weeks and reduced glucose variability. HbA1c was similar. The trial was funded by JDRF and Australia's NHMRC (Waibel 2023).

These are worth watching precisely because they are cheap, off-patent or already widely used. That also means no company has a strong incentive to fund the large confirmatory trials.

Islet transplants and stem-cell islets

Donor islets. NICE advises considering referral for islet or pancreas transplantation for adults with recurrent severe hypoglycaemia despite other treatments, or for those already on immunosuppression after a kidney transplant (NICE NG17 1.8). In the NIH-funded CIT-07 trial, 48 adults with persistent severe hypos received purified donor islets. 87.5% met the primary goal (HbA1c below 7% and no severe hypos) at one year and 71% at two years, and hypo awareness was restored. Five people (10.4%) had bleeds needing transfusion, two had infections, and kidney function fell on immunosuppression (Hering 2016). In the US, the FDA approved a donor-islet product, Lantidra (CellTrans Inc.), in June 2023. In its trials, 21 of 30 people were insulin-free for a year or more, and 5 never achieved any insulin-free days (FDA).

Stem-cell islets (zimislecel, formerly VX-880). Vertex makes fully differentiated islet cells from stem cells and infuses them into the liver's portal vein. In the Vertex-funded phase 1–2 FORWARD study, all 14 analysed participants began making insulin. All 12 who received a full dose were free of severe hypos with HbA1c below 7%, and 10 of the 12 (83%) were off insulin at one year. Two participants died: one from cryptococcal meningitis, and one from progression of pre-existing dementia. Neutropenia was the commonest serious adverse event (Reichman 2025). Everyone took glucocorticoid-free immunosuppression, which is why the therapy targets people with severe hypoglycaemia rather than everyone with type 1 diabetes.

Status as of October 2026. Vertex had planned regulatory submissions in 2026 (Breakthrough T1D Canada). It then paused final dosing in its phase 1/2/3 study for an internal manufacturing analysis. In its first-quarter 2026 results it said the analysis was complete and dosing had resumed (Vertex Q1 2026). In its second-quarter 2026 results (August), Vertex said the study "continues to enrol and dose patients". It said it would give updated timelines for zimislecel and VX-017, a version designed to treat eligible patients regardless of blood type, "later this year" (Vertex Q2 2026). We found no evidence of a submitted application or an approval anywhere. Vertex stopped a separate encapsulated product, VX-264, in 2025 because it did not produce enough insulin (Breakthrough T1D Canada).

Supplements and lifestyle claims

Diet. There is no special "type 1 diet". The aim is to match insulin to what is eaten, which is what DAFNE-style education teaches (NICE NG17). Very low-carbohydrate eating is popular online. The only widely cited data come from an NIH-funded survey of members of a social media group who chose the diet. It reported excellent HbA1c and few hospital stays, but it cannot show cause and effect (Lennerz 2018). Anyone changing carbohydrate intake substantially needs insulin doses reviewed with their team.

Vitamin D. Babies given vitamin D supplements were less likely to develop type 1 diabetes later in a pooled analysis of four case-control studies, and one cohort study agreed. No randomised trial has tested this (Zipitis 2008). Our vitamin D review covers dosing and safety.

"Cure" products. NCCIH warns that products marketed as a "natural diabetes cure" or to "replace your diabetes medicine" are sold illegally. All are harmful if used instead of effective treatment (NCCIH). For type 1 diabetes, where missing insulin leads to DKA, this is a life-or-death point.

Risks of common treatments

Insulin

Hypoglycaemia is the main risk of insulin and rises as glucose targets get tighter: two to three times more severe hypos with intensive therapy in the DCCT (DCCT 1993). NICE says HbA1c targets must not come at the cost of problematic hypoglycaemia. It advises that a trained family member or friend should be able to give glucagon when someone cannot safely swallow (NICE NG17 1.6.8, 1.9.11).

Pumps, sensors and closed-loop systems

Devices fail. In February 2020, the FDA classed a Medtronic recall of MiniMed 630G and 670G pumps as Class I, its most serious category. A missing or broken retainer ring could cause under- or over-delivery of insulin. The FDA reported 26,421 complaints, and the company was aware of 2,175 injuries and one death (Healio). Because pumps use only rapid-acting insulin, a delivery failure can lead to ketosis quickly. That is why NICE ties HCL use to a trained specialist team and structured education (NICE TA943 1.4–1.5). Skin reactions to sensor adhesives and alarm fatigue are common complaints, but we did not find independent incidence figures.

Teplizumab

The most common adverse reactions are lymphopenia, vomiting, rash, leukopenia, diarrhoea, neutropenia, raised liver enzymes and headache. Cytokine release syndrome can occur, and pre-medication and liver monitoring are required. Serious cases of viral reactivation occurred mostly in people who continued treatment despite persistent severe lymphopenia, and severe lymphopenia may last longer in adults. Pregnancy should be avoided during treatment and for 30 days before a planned pregnancy (FDA label).

Transplants and cell therapy

In CIT-07, procedure-related bleeds affected 10.4% of people, and kidney function declined on immunosuppression (Hering 2016). Most Lantidra recipients had at least one serious adverse event related to the infusion or immunosuppression (FDA). Two of 14 zimislecel participants died, one from an opportunistic fungal infection (Reichman 2025).

Who to see

• New symptoms (the 4 Ts): urgent same-day GP appointment or NHS 111. Call 999 or go to A&E for DKA symptoms (NHS).
• After diagnosis: a specialist diabetes team (consultant diabetologist or paediatric diabetes team, diabetes specialist nurse, dietitian). NICE asks for coordinated care from a range of professionals (NICE NG17 1.2.2).
• Technology: CGM, pumps and HCL should be started and supported by a multidisciplinary team experienced in these devices (NICE TA943 1.4).
• Recurrent severe hypos: ask about referral to a centre that assesses people for islet or pancreas transplantation (NICE NG17 1.8.1).
• Relatives of people with type 1 diabetes: ask about autoantibody testing in research programmes; a positive test is the gateway to teplizumab (NICE TA1176).
• Annual checks: eyes, kidneys, feet, blood pressure and lipids. Heart risk is covered in our diabetes and heart disease review.

Follow the money: who funds the research and who profits

Who makes and sells the treatments

Insulin. Three multinationals, Eli Lilly (US), Novo Nordisk (Denmark) and Sanofi (France), control more than 90% of the world insulin market. WHO says this leaves little space for smaller competitors (WHO 2021). In a RAND study sponsored by the US Department of Health and Human Services, US manufacturer list prices per 100 units averaged 9.71 times those of 33 other OECD countries combined in 2022. After estimated rebates, US net prices were still 2.33 times higher (RAND 2024).

In March 2023, all three announced US list-price cuts:

• Lilly by 70% on its main insulins, with a $35 monthly out-of-pocket cap (HCPLive);
• Novo Nordisk by up to 75% (PBS);
• Sanofi by 78% on Lantus, with a $35 cap for commercially insured patients (ABC7).

Separately, Medicare now caps patients' costs at $35 for a month's supply of each covered insulin (Medicare.gov). The caps limit what some patients pay. They do not change the market structure WHO describes, and people without coverage can still face high costs.

Devices. CGM and pump makers include Abbott, Dexcom, Insulet, Tandem and Medtronic, all of which appear on the ADA's 2023 donor list (ADA disclosure). NICE's approval of HCL is explicitly conditional on prices agreed between "the companies and NHS England" (NICE TA943).

Teplizumab. It was developed in academic and NIH-funded trials, held by MacroGenics and then Provention Bio (TN-10 full text). Sanofi completed its $2.9 billion purchase of Provention Bio in April 2023 (DCAT). Most of the evidence that won approval was therefore paid for by US taxpayers and two charities (JDRF and the American Diabetes Association), while the commercial rights now belong to a French multinational that is also one of the three big insulin makers.

Cell therapy. Vertex (US) acquired Semma Therapeutics, the stem-cell islet company built on scientist Douglas Melton's work, for $950 million in cash in 2019 (JDCA). Zimislecel grew out of that programme. CellTrans holds the US approval for the donor-islet product Lantidra (FDA).

Who funds the research

US government. The NIH's Special Diabetes Program has provided $150 million a year for type 1 diabetes research since FY2004, apart from sequestration cuts. It needs repeated renewal by Congress (NIDDK). NIDDK funded the DCCT, the iDCL closed-loop trial and the CLVer verapamil trial, and with JDRF and the American Diabetes Association it funded TrialNet's TN-10 (Herold 2019).

Breakthrough T1D (formerly JDRF). The charity renamed itself in June 2024 (AJMC). Its US tax filing for the year to June 2025 reports revenue of $301.7 million, 91.8% of it from contributions (ProPublica 990). It funded the T1D Index modelling study (Gregory 2022), co-funded the BANDIT trial (Waibel 2023) and helped write the staging system that defines teplizumab's market (Insel 2015). Its corporate partner page places Lilly, MiniMed and Sanofi in its $1 million to $2.499 million band, Abbott and Novo Nordisk in its $500,000 to $999,999 band, and Dexcom and Vertex in its $250,000 to $499,999 band. It also describes an Industry Advisory Panel, whose members include Abbott, Dexcom, MiniMed, Novo Nordisk and Vertex, that gives companies a forum to give feedback on the charity's strategies and research priorities (Breakthrough T1D). None of this shows wrongdoing. It does mean the charity's research agenda and the companies' commercial agenda overlap closely.

American Diabetes Association. The ADA writes the influential US Standards of Care. It published an unaudited draft listing $24.8 million received from drug and device makers in 2023 (ADA disclosure):

Trial sponsors. The key device and drug trials were paid for by the companies whose products they tested: DexCom for DIAMOND (registry), Provention Bio and Sanofi for PROTECT (registry), and Vertex for zimislecel (registry). The publicly funded trials (DCCT, TN-10, iDCL, CLVer, CIT-07) are the backbone of the independent evidence. Even these relied on companies to donate drugs or devices.

Documented integrity and access events

• Class I recall of Medtronic MiniMed 630G and 670G pumps, reported in February 2020, with 2,175 injuries and one death known to the company (Healio).
• FDA and FTC warning letters to 10 companies illegally selling supplements claiming to treat diabetes (FDA).
• Novo Nordisk's discontinuation of Levemir, NICE's preferred basal insulin, with UK supply expected to end in December 2026 (NICE NG17).
• A June 2026 boxed warning added to teplizumab for viral reactivation, nearly four years after first approval (FDA label).

Related research

For wider, evidence-graded context, see these Pure City Research guides:

• Type 2 diabetes: prevention and management evidence
• Diabetes supplements: benefits, limits and safety
• Diabetes and heart disease
• Coeliac disease: treatments and evidence
• Coeliac disease testing
• Autoimmune disease and the heart
• Chronic kidney disease and the heart
• Vitamin D: D2 vs D3, deficiency and safety
• Berberine: glucose evidence and safety
• Atrophic and autoimmune gastritis

Frequently asked questions

Sources and funding notes

What we could not verify: the current US list price of teplizumab (pricing pages blocked our access); the EU marketing status of teplizumab; the full text and author conflict statements of the zimislecel, PROTECT and DIAMOND papers (paywalled; we relied on abstracts and registry sponsor records); funding for the 2008 vitamin D meta-analysis; the size of Breakthrough T1D's T1D Fund stake in Semma Therapeutics (the charity's original announcement is no longer online); the exact amount and time period of each Breakthrough T1D corporate partner's giving (the page shows only dollar bands); the share of ADA revenue that the $24.8 million represents; independent rates of sensor skin reactions; and any Vertex announcement after its August 2026 results. The exact date of the FDA/FTC warning letters is reported elsewhere as September 2021, but we could not see the date on the FDA page.

1. NICE NG17: Type 1 diabetes in adults (published 2015, updated August 2022) — UK guideline; NICE is sponsored by the Department of Health and Social Care (GOV.UK).
2. NICE TA943: Hybrid closed loop systems (19 December 2023) and committee discussion — UK health-technology appraisal.
3. NICE TA1176: Teplizumab (9 July 2026), price and committee discussion — UK appraisal; evidence submitted by Sanofi.
4. NICE TA151: Continuous subcutaneous insulin infusion — UK appraisal.
5. Tzield (teplizumab-mzwv) US prescribing information, revised June 2026 (DailyMed) — FDA-approved label; labeller Provention Bio (Sanofi).
6. MHRA: approval of teplizumab (14 August 2025) — UK regulator.
7. AJMC: Teplizumab approved by FDA (18 November 2022) — trade journal report of the FDA approval.
8. FDA: approval of Lantidra (28 June 2023) — US regulator; product of CellTrans Inc.
9. NHS: Symptoms of type 1 diabetes, Diabetic ketoacidosis and Low blood sugar — UK public health service.
10. NIDDK: Type 1 diabetes — US government (NIH).
11. DCCT Research Group. N Engl J Med 1993;329:977–86 — landmark RCT; NIDDK (DCCT/EDIC coordinating centre).
12. Herold KC et al. Teplizumab in relatives at risk. N Engl J Med 2019 (full text) — TrialNet RCT; NIH, JDRF and the American Diabetes Association; drug from MacroGenics.
13. Ramos EL et al. Teplizumab in newly diagnosed T1D (PROTECT). N Engl J Med 2023 — RCT; funded by Provention Bio and Sanofi (NCT03875729).
14. Brown SA et al. Closed-loop control (iDCL). N Engl J Med 2019 (full text) — RCT; NIDDK; devices from Tandem.
15. Beck RW et al. CGM in injection users (DIAMOND). JAMA 2017 — RCT; lead sponsor DexCom (NCT02282397).
16. Gregory GA et al. Global type 1 diabetes 2021–2040. Lancet Diabetes Endocrinol 2022 — modelling study; funded by JDRF International.
17. Insel RA et al. Staging presymptomatic type 1 diabetes. Diabetes Care 2015 — statement of JDRF, Endocrine Society and ADA; NIDDK grants listed.
18. Hering BJ et al. Islet transplantation phase 3 (CIT-07). Diabetes Care 2016 — single-arm trial; NIH (NIAID, NIDDK).
19. Reichman TW et al. Stem cell-derived islets (zimislecel). N Engl J Med 2025 — phase 1–2; funded by Vertex (NCT04786262).
20. Forlenza GP et al. Verapamil in pediatric T1D (CLVer). JAMA 2023 and McVean J et al. Tight glycaemic control arm. JAMA 2023 — RCTs; NIDDK grants.
21. Waibel M et al. Baricitinib in new-onset T1D (BANDIT). N Engl J Med 2023 — RCT; JDRF and NHMRC (Australia).
22. Lennerz BS et al. Very low-carbohydrate diet in T1D. Pediatrics 2018 — online survey; NIH grants.
23. Zipitis CS, Akobeng AK. Vitamin D in early childhood and T1D. Arch Dis Child 2008 — meta-analysis of observational studies; no funding statement seen.
24. NCCIH: Diabetes and dietary supplements — US government.
25. FDA/FTC warning letters to 10 diabetes supplement companies — US regulators.
26. WHO: report on insulin access (12 November 2021) and full report — WHO.
27. Mulcahy AW, Schwam D. Comparing insulin prices in the US to other countries (RAND, 2024) — sponsored by HHS ASPE.
28. HCPLive: Lilly insulin price cuts (1 March 2023); PBS: Novo Nordisk price cuts; ABC7: Sanofi price cuts — news reports of company announcements.
29. Medicare.gov: Insulin coverage — US government.
30. NIDDK: About the Special Diabetes Program — US government.
31. ProPublica Nonprofit Explorer: Breakthrough T1D Form 990 — IRS filing data.
32. Breakthrough T1D: Meet our corporate partners and AJMC: JDRF renamed (4 June 2024) — charity disclosure; trade journal.
33. American Diabetes Association: revenue from pharmaceutical/device makers, 2023 (unaudited draft) — charity disclosure.
34. Vertex Q1 2026 results and Q2 2026 results (press releases republished by CRISPR Medicine News) — company statements.
35. Breakthrough T1D Canada: Important update on Vertex trials (April 2025) — charity summary of company announcement.
36. JDCA: Semma Therapeutics acquired by Vertex for $950M (2019) — patient-advocacy analysis.
37. DCAT: Sanofi completes $2.9bn acquisition of Provention Bio (27 April 2023) — industry news.
38. Healio: Medtronic recalls MiniMed pumps (12 February 2020) — medical news report of FDA Class I recall.

Educational research reviewed 7 October 2026. This article is not medical advice; talk to a qualified clinician or pharmacist before starting, stopping or combining treatments.