The headline trial: ADJUNCT-ONE and ADJUNCT-TWO + BARI-OPTIMISE
ADJUNCT-ONE / ADJUNCT-TWO (Mathieu Diabetes Care 2016) for liraglutide in T1D; BARI-OPTIMISE (Mok Lancet D&E 2024) for post-bariatric regain
ADJUNCT 2016; BARI-OPTIMISE 2024
GLP-1 RA in T1D produces modest A1c reduction (0.4 to 0.6 percent), meaningful weight loss (5 to 8 kg over 52 weeks) and reduced insulin requirements (10 to 20 percent). DKA risk is real and requires careful insulin titration. Post-bariatric T1D patients with weight regain are a complex but increasingly common clinical scenario.
Trial enrollment criteria
- T1D documented with ICD-10 E10.x and on insulin therapy
- Bariatric surgery history with documented weight regain
- Stable A1c and no recent DKA
- Current BMI greater than or equal to 30 or 27 with comorbidity
Does this trial apply to you?
This is one of the most clinically complex cases on the site. T1D itself is not an FDA-labeled indication for any GLP-1 RA in 2026; use is off-label. Post-bariatric regain adds the obesity-indication path. The PA case requires an endocrinologist as the principal prescriber, with explicit DKA risk-mitigation language, insulin-titration plan and the bariatric surgeon as a co-signer if available.
What to ask your prescriber
- Whether an endocrinologist (not just PCP) is willing to lead this prescribing pathway
- Recent A1c, time-in-range from CGM, DKA history
- Insulin-titration plan during GLP-1 initiation
- Patient education on DKA warning signs and pause protocols
Editorial notes
- DKA risk is the dominant safety concern. Patient must have CGM, written sick-day rules and a clear pause-and-rehydrate protocol.
- Insulin reduction during GLP-1 initiation is typically 10 to 20 percent; insulin pump users coordinate basal-rate adjustments.
- This is a high-acuity case; PA approval often requires peer-to-peer review with the plan's medical director.
Clinical trials for Type 1 diabetes with post-bariatric weight regain
Or browse the full GLP-1 clinical trials directory, filterable by condition, state and phase.
Take it to your prescriber: PA letter templates
Editable prior-authorization letter templates that cite the registration trial above. Pick the plan your prescriber will submit to, copy the template, fill in the patient-specific findings and have your clinician sign and submit.
Not seeing your plan? The full PA letter librarycovers 20 plans × 10 indications = 200 templates. The appeal letter library handles denials.
Drug profiles
Other GLP-1 conditions
Editorial provenance
Editorial review by John, Editor on 2026-05-23, against ADJUNCT-ONE and ADJUNCT-TWO + BARI-OPTIMISE (ADJUNCT 2016; BARI-OPTIMISE 2024). We do not yet have a credentialed medical reviewer on staff (actively recruiting). This page summarises public registration-trial data and FDA labeling. It is not clinician-authored medical advice.
Disclaimer
Educational summary of published registration trial data. Not medical advice. Not a substitute for evaluation by a treating clinician. Trial-level results do not guarantee individual outcomes. Discuss eligibility, contraindications, dose adjustments and drug interactions with your prescriber. We do not have a credentialed medical reviewer on staff yet (actively recruiting); the content below is editor-written from public registration-trial publications and FDA labeling, not clinician-authored medical advice.