Research and trials

Consensus report outlines safety guidance for semaglutide and tirzepatide in type 1 diabetes

A new consensus report gives clinicians and patients practical safety guidance for GLP-1 drugs in type 1 diabetes, a use for which none of the drugs is approved.

By the Semaglutides news desk·
Consensus report outlines safety guidance for semaglutide and tirzepatide in type 1 diabetes
Image: doi.org

A consensus report published in the journal Diabetes Technology & Therapeutics states that no GLP-1 or dual GIP/GLP-1 receptor agonist has been approved to treat type 1 diabetes, and offers practical safety guidance for people with type 1 diabetes who are already using these drugs [1][2].

The report says regulatory approval for weekly GLP-1 and GLP-1/GIP receptor agonists in type 1 diabetes has not been achieved. One reason it gives is the small number of inconsistent, small-scale randomized controlled trials and real-world studies of blood sugar effects in type 1 diabetes; larger randomized trials in people with type 1 diabetes are ongoing or planned [1][2]. These drugs are currently approved for type 2 diabetes, obesity, sleep apnea, and metabolic dysfunction-associated steatohepatitis with moderate-to-advanced fibrosis [1][2]. GLP-1 drugs have been available since exenatide was introduced in 2005 [1].

The main safety risks the authors name for type 1 diabetes are hypoglycemia and hyperglycemia-related ketosis after starting a GLP-1 or GLP-1/GIP drug [1][2]. Topics listed under the guidance include gastrointestinal side effects, diabetic eye disease, glucose and ketone monitoring, blood sugar control, and insulin dose changes [2].

The report focuses on semaglutide and tirzepatide, which the authors say they wanted to address for type 1 diabetes management [1]. Access to these drugs is already possible when they are prescribed to treat overweight or obesity, the report notes. But without approval for a type 1 diabetes indication, the authors write, access and opportunities for people with type 1 diabetes to get safety education may be limited, and that limits support from diabetes health care professionals in managing the drugs alongside expected insulin dose changes [1][2].

The guidance is based on a literature search of MEDLINE, PubMed and the Cochrane Library covering articles published up to February 9, 2026 [1]. The report was endorsed by six organizations: Advanced Technologies & Treatments for Diabetes, International Diabetes Federation–Europe, the American Association of Clinical Endocrinologists, Breakthrough T1D, the International Society for Pediatric and Adolescent Diabetes, and the Association of Diabetes Care and Education Specialists [1][2]. The lead author is Satish K. Garg, with coauthors including Halis K. Akturk, Roy W. Beck and Kelly Close [1].

Why it matters for patients

For adults with type 1 diabetes, the practical effect is a gap between what is approved and what is already happening. Insurance coverage and prescribing for these drugs generally rest on an obesity or overweight diagnosis, not on type 1 diabetes itself [1][2]. That can leave the insulin adjustments that usually follow starting one of these drugs without the same structured oversight a labeled use would bring [1][2]. The report treats education on glucose and ketone monitoring as part of safe use, which points to what patients and their clinicians would need to track [2]. It does not recommend doses, and no trial results in type 1 diabetes have been reported that would support a labeled use.

What happens next

The report says larger randomized controlled trials in people with type 1 diabetes are ongoing or planned [1][2], but no completion dates or results have been disclosed. No regulatory submission or approval for a type 1 diabetes indication has been reported [1][2].

Sources

  1. https://doi.org/10.1177/15209156261449879
  2. https://pubmed.ncbi.nlm.nih.gov/42246488/

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