French-US Trial: Tubeless Insulin Pump Beats CGM Alone for Type 1

French-US Research Shows Tubeless Automated Insulin Delivery Delivers Major Blood Sugar Gains

A study from France — conducted jointly with US centers — offers powerful new evidence that tubeless automated insulin delivery (AID) systems significantly outperform standard insulin pump therapy combined with continuous glucose monitoring (CGM) in adults with Type 1 diabetes who are struggling to meet their blood sugar goals.

What Makes This International Perspective Valuable?

Because this trial was conducted simultaneously in both France and the United States, its findings carry exceptional weight for American patients. European diabetes care systems often pioneer technology adoption protocols and real-world clinical structures that differ from US practice. The fact that both healthcare environments produced consistent results strengthens confidence that these benefits apply broadly — regardless of where you receive care.

What the Study Did

Researchers from Montpellier University Hospital and INSERM in France, working alongside US investigators, enrolled 194 adults aged 18–70 with Type 1 diabetes and HbA1c levels between 7% and 11% — indicating suboptimal blood sugar control. Participants were randomly assigned either to the Omnipod 5 tubeless AID system (132 people) or to continuing their existing pump therapy with a CGM (62 people) for 13 weeks.

Key Findings — In Plain English

The results were striking:

• More time in healthy range: The AID group spent an average of 4.2 additional hours per day with blood sugar in the target range of 70–180 mg/dL. In percentage terms, that's a 17.5% improvement — a clinically meaningful gain by any standard.
• Better HbA1c: The AID group reduced their HbA1c by an average of 1.24 percentage points, compared to just 0.68 points in the pump-with-CGM group.
• Fewer dangerous highs: Time above 180 mg/dL dropped to 37.6% in the AID group versus 54.5% in the control group.
• Fewer dangerous lows: Time below 70 mg/dL was also lower in the AID group (1.18% vs. 1.75%), meaning better control without increased hypoglycemia risk.
• Zero severe events: No cases of diabetic ketoacidosis (DKA) or severe hypoglycemia occurred in the AID group during the entire 13-week trial.

How This Compares to US Guidelines

The American Diabetes Association (ADA) currently recommends a Time in Range (TIR) target of at least 70% for most adults with Type 1 diabetes, with less than 4% of time spent below 70 mg/dL. The Omnipod 5 group in this trial approached or met these benchmarks, while the standard pump-with-CGM group fell short — underscoring a real gap in care that AID technology can close.

Why This Matters for US Patients

Approximately 1.6 million Americans live with Type 1 diabetes, and many still rely on traditional insulin pumps or multiple daily injections, even when CGM is available. This study — validated across two countries — provides some of the strongest evidence yet that tubeless AID systems like the Omnipod 5 should be considered a preferred first-line therapy, not just an upgrade. If you or a loved one has an HbA1c above 7% despite using a pump and CGM, this research suggests a conversation with your endocrinologist about AID technology is well worth having. Insurance coverage for AID systems is expanding in the US, making access more realistic than ever.

Study Citation

Renard, Weinstock, Aleppo, et al. "Efficacy and Safety of a Tubeless AID System Compared With Pump Therapy With CGM in the Treatment of Type 1 Diabetes in Adults With Suboptimal Glycemia: A Randomized, Parallel-Group Clinical Trial." Diabetes Care, 2024. DOI: 10.2337/dc24-1550 | PMID: 39423118