2023 was a big year in the world of diabetes, from the FDA’s approval of a new bionic pancreas to promising cell therapy trials and lots of stuff in between. It’s easy to forget how far we’ve come in such a short time period, so here’s a recap of several key advancements made this year.
Rybelsus Now First Line Therapy Option for People with Type 2 Diabetes
Rybelsus is an oral semaglutide tablet (GLP-1 RA) for people with type 2. In addition to its glucose-lowering effects, Rybelsus has also been found to help protect the heart.
Dexcom G7 Available in U.S.
The long-awaited G7 became commercially available for people with type 1, type 2, and gestational diabetes ages two and older, offering a smaller profile, combined sensor and transmitter, and redesigned mobile app.
Tidepool Loop Receives FDA Clearance
Born from the #WeAreNotWaiting community of innovators, Tidepool Loop is the first automated insulin dosing app cleared to enable control from a compatible Apple Watch.
Insulin price cuts from Lilly, Novo Nordisk, and Sanofi
In August 2022, the Inflation Reduction Act (IRA) was passed by the U.S. Congress. Through this act (which took effect in January 2023), insulin copays were capped at $35/month for people with Medicare. Not long after, steps were taken by the big three insulin manufacturers to address the needs of those enrolled in private and public insurance plans, as well as the uninsured.
Medicare Expands CGM Coverage for T2
The Centers for Medicare & Medicaid Services expanded coverage for CGMs to cover all people with diabetes treated with insulin, or those who have hypoglycemia and have had at least one of the following: two or more level 2 hypoglycemic events (glucose <54 mg/dL) that persist despite multiple modifications to the treatment plan, one level 3 hypo event (glucose <54 mg/dL) characterized by altered mental and/or physical state requiring third-party assistance for treatment.
Medtronic’s 780G Receives FDA Approval
The MiniMed 780G has “meal detection technology” that provides automatic adjustments and corrections to sugar levels every five minutes, and helps cover for underestimated carb counts or an occasional missed meal bolus. The MiniMed 780G insulin pump pairs with the new Guardian 4 sensor. The new system also allows for targets as low as 100 mg/dL.
Omnipod GO, a Basal-Only Insulin Pod, Cleared by the FDA
Omnipod GO is a wearable insulin delivery system that provides a fixed rate of continuous rapid-acting insulin for 72 hours. It features a tubeless pod and operates without the need for a handheld device. It was developed for people with type 2 diabetes earlier in their treatment journey, and is cleared for use with several U-100 insulins including NovoLog, Fiasp, Humalog, and Lyumjev.
FDA Clears iLet Bionic Pancreas System
The iLet Bionic Pancreas is the first and only automated insulin-delivery system that determines 100% of all insulin doses. There’s no carb detailed counting, no corrections, and no calculating boluses, and it only needs your body weight to get started.
Vertex Trial Data Show Two T1D Patients Reach Insulin Independence with Cell Therapy
Vertex Pharmaceuticals released one-year follow-up data from a Phase I/II clinical trial of its investigational stem cell-based therapy VX-880, showing that two patients with Type 1 diabetes no longer needed insulin injections.
FDA Approves Lantidra, the First Ever Cell Therapy for Type 1 Diabetes
Lantidra is a cell therapy that helps to restore functional pancreatic islet cells in people who are unable to produce insulin. It’s the first cell therapy to ever be approved by the FDA for people with type 1 diabetes.
Medtronic MiniMed 780G Now Available in the US, Covered by Medicare
Tandem Mobi Gets FDA Approval
The Tandem Mobi is roughly half the size of Tandem’s t:slim X2 and features a 200-unit insulin cartridge plus an on-pump button that provides an alternative option to phone control for bolusing.
Brenzavvy, a Type 2 Diabetes Drug, Now Available for Less Than $50 Per Month
Brenzavvy is a once-daily medication designed to lower blood sugar levels in adults with type 2 diabetes.
Amazon Pharmacy Unveils $35 Monthly Insulin
Amazon Pharmacy announced that it will begin automatically applying manufacturer coupons to more than 15 common insulin and diabetes devices. This includes Lilly’s Humalog, Humulin, and Lispro insulins, as well as Novo Nordisk’s Novolog and Sanofi’s Lantus.
Jardiance approved to prevent the progression of kidney disease
The FDA approved Jardiance 10 mg tablets to lower the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease at risk of progression.
Tzield Shown to Delay T1D in Newly Diagnosed Youth
Tzield’s phase 3 data presented at ISPAD showed the potential to slow the progression of Stage 3 type 1 diabetes in newly diagnosed children and adolescents. For the approximately 60,000 people in the U.S. diagnosed with T1D every year, it could mean they will have a viable treatment option to slow the progression of the disease.
Medtronic’s Simplera CGM Approved in Europe
Simplera is half the size of the Guardian 4, is flat, and has a streamlined two-step insertion process. It’s not yet available in the U.S. but is expected to be approved by spring 2024.
FDA Approves New Version of Diabetes Drug Mounjaro for Weight Loss, called Zepbound
Tirzepatide, the active ingredient in Zepbound, is approved under the name Mounjaro to help improve blood sugar in adults with type 2 diabetes. The FDA approved Zepbound for chronic weight management in adults with obesity or who are overweight with at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
FDA approves Tandem Mobi for Ages 2 and up
The year isn’t over yet, and we can’t wait to see what 2024 has in store!