Jardiance Adolescent (12-17) Transition to Adult Care

Why the FDA Approved Empagliflozin for Adolescents

The FDA granted approval for empagliflozin in patients aged 10 and older in December 2023, making it one of the few oral agents with pediatric labeling for type 2 diabetes. That decision rested primarily on the DINAMO trial, a 26-week, double-blind, placebo-controlled study in 157 pediatric patients aged 10 to 17 with type 2 diabetes. The approval reflected a real gap: metformin and insulin had been the only broadly used options in this age group for years.

What DINAMO Showed

In DINAMO (NCT03429543), empagliflozin 10 mg reduced HbA1c by a placebo-adjusted 0.84 percentage points at 26 weeks (P<0.001) [1]. The 25 mg dose arm showed a similar reduction of 0.94 percentage points. Body weight and fasting plasma glucose also fell significantly in both active arms compared with placebo.

Both doses were generally well tolerated. The adverse event profile in adolescents mirrored the adult experience, including genital mycotic infections in approximately 4 to 5 percent of female participants, and a small number of urinary tract infections [1].

FDA Label Specifics for Age 12-17

The approved starting dose is 10 mg orally once daily in the morning, with or without food [2]. Titration to 25 mg once daily is permitted after tolerability is confirmed, typically after 4 to 8 weeks. The FDA label explicitly states that empagliflozin should not be used in patients with eGFR <45 mL/min/1.73 m² and is not indicated for type 1 diabetes in any age group [2].

Patients in the 12 to 17 age bracket sit squarely in the window where puberty-driven insulin resistance peaks, making glycemic control particularly difficult. Adding an SGLT2 inhibitor to metformin or to a basal insulin regimen can lower HbA1c without the hypoglycemia risk seen with sulfonylureas [3].

The Core Problem With Pediatric-to-Adult Care Transitions

Transition from pediatric to adult care is one of the highest-risk periods for medication discontinuation and glycemic deterioration in adolescents with chronic disease. A 2018 cohort study published in JAMA Internal Medicine found that young adults with type 1 diabetes who experienced a gap in endocrinology care had a 2.4-fold higher odds of diabetic ketoacidosis within 12 months of transfer compared with those who maintained continuous care [4].

Type 2 diabetes carries its own transition hazards. Youth-onset type 2 diabetes progresses faster than adult-onset disease. The TODAY trial (N=699) demonstrated that roughly 50 percent of youth with type 2 diabetes on metformin alone experienced treatment failure within 3.86 years, underscoring how aggressive this disease trajectory is in the adolescent population [5].

Why Adolescents Stop Medications After Transfer

Several factors drive post-transition non-adherence:

• Insurance gaps during the 18-26 age window disrupt prescription access.
• Adult providers unfamiliar with SGLT2 inhibitors in young patients may deprescribe.
• Patients lose the parental scaffolding that supported adherence during adolescence.
• Copays for brand-name Jardiance can exceed $500 per month without coverage [6].

The ADA Standards of Care, Section 14.27, explicitly states: "Youth with type 2 diabetes should be transitioned to adult care by age 18, ideally with a structured handoff that includes a minimum of one joint visit with both the pediatric and adult provider before formal transfer" [3].

What "Structured Handoff" Means in Practice

A structured handoff for an adolescent on empagliflozin includes at minimum: a medication reconciliation letter, a current HbA1c, a recent eGFR and urine albumin-to-creatinine ratio (UACR), documentation of any prior DKA episodes or genital mycotic infections, and a list of all concurrent medications. Ideally the handoff occurs between ages 16 and 18, not on the 18th birthday.

Monitoring Requirements That Must Transfer With the Patient

Empagliflozin requires ongoing laboratory surveillance regardless of patient age. Adult providers receiving a transferred adolescent need to continue the monitoring schedule without interruption.

Renal Function

The FDA label specifies eGFR assessment before initiating empagliflozin and periodically thereafter [2]. In adolescents who began the drug at age 12, the first adult provider visit should include a repeat basic metabolic panel and eGFR, since renal function can shift during late adolescence, especially in patients with obesity or hypertension.

Empagliflozin is not recommended when eGFR falls below 45 mL/min/1.73 m² for glycemic indication. In the EMPA-KIDNEY trial (N=6,609), empagliflozin 10 mg reduced the composite of kidney disease progression or cardiovascular death by 28 percent in adults with CKD, but that indication has not been studied in the under-18 population [7].

HbA1c and Glucose Monitoring

HbA1c should be checked every 3 months during the first year after transition, consistent with ADA guidance for patients not meeting glycemic targets [3]. For patients on empagliflozin plus insulin, a continuous glucose monitor (CGM) check and review of time-in-range data at every visit reduces the risk of under-treated hyperglycemia.

UACR and Blood Pressure

Youth-onset type 2 diabetes carries an elevated risk of nephropathy even in the teenage years. The ADA recommends annual UACR screening starting at diagnosis in youth with type 2 diabetes [3]. Empagliflozin independently reduces albuminuria; the receiving adult provider should document baseline UACR at the first visit to track trajectory [7].

Safety Signals Unique to the 12-17 Age Group

Diabetic Ketoacidosis Risk

SGLT2 inhibitors carry an FDA black-box-adjacent warning for diabetic ketoacidosis, including euglycemic DKA, which can occur with blood glucose values that appear near-normal [2]. The risk is amplified in situations that mimic fasting: surgical procedures, prolonged vomiting, very low-carbohydrate diets, and intense prolonged exercise.

The FDA advises withholding empagliflozin at least 3 days before elective surgery [2]. Adolescents transitioning to adult care may undergo surgical procedures (orthopedic, dental, or other) with adult providers who are unaware of this SGLT2-specific perioperative rule. This is precisely the type of information that must appear in the handoff documentation.

In a pharmacovigilance review of SGLT2 inhibitor use, the FDA identified 73 cases of DKA requiring hospitalization, many with blood glucose values <250 mg/dL, prompting a safety communication in 2015 [8]. Adolescents and young adults with atypical eating patterns or caloric restriction for weight management are at heightened risk.

Genital Mycotic Infections

Approximately 4 to 5 percent of adolescent females in DINAMO developed vulvovaginal mycotic infections [1]. This rate is consistent with adult female data from the EMPA-REG OUTCOME trial, where genital infections occurred in 9.9 percent of women on empagliflozin 25 mg over a median 3.1 years [9]. Adolescent patients should receive counseling about genital hygiene, and the receiving adult provider (or gynecologist) should be aware of this ongoing risk.

Bone Health and Growth

SGLT2 inhibitors modestly affect phosphate homeostasis via FGF-23 signaling. The clinical significance in adolescents, whose bone mineral accrual is active during peak growth, has not been fully characterized in long-term studies [10]. The DINAMO trial was only 26 weeks, which is insufficient to detect bone density changes. Adult providers should document height, weight, and, where clinically indicated, DEXA scan data at transition.

Building the Transition Plan: A Step-by-Step Framework

Transition planning for an adolescent on empagliflozin should begin no later than age 15 or 16, not at the last pediatric visit. The following framework organizes the process into three phases.

Phase 1: Preparation (Ages 15-17)

The pediatric team should begin teaching the adolescent self-management skills that were previously managed by parents: filling prescriptions independently, understanding the perioperative hold rule, recognizing DKA symptoms (nausea, vomiting, abdominal pain, fruity breath even with near-normal glucose), and communicating medication lists to other providers.

A transition readiness checklist validated in youth with chronic illness, such as the Transition Readiness Assessment Questionnaire (TRAQ), can identify specific skill gaps before the formal handoff [11]. Insurance coverage review should occur at this stage, not after transfer, to prevent medication gaps at age 18 or 26.

Phase 2: Joint Handoff Visit (Age 17-18)

The ADA supports at least one joint visit involving both the pediatric and adult provider [3]. At this visit the receiving provider should review:

• Current HbA1c, eGFR, UACR, lipid panel, and blood pressure.
• Empagliflozin dose (10 mg or 25 mg), any prior dose adjustments, and reason.
• Prior adverse events: DKA episodes, genital infections, urinary tract infections.
• Concurrent medications: metformin, insulin, ACE inhibitors, contraceptives (important given SGLT2-related genital infection risk).
• Psychosocial factors: depression screening (PHQ-9), diabetes distress, food insecurity.

Phase 3: First-Year Adult Care (Ages 18-19)

Quarterly HbA1c checks, blood pressure monitoring at every visit, and annual UACR are the minimum surveillance requirements [3]. The adult provider should also reassess whether dose escalation to 25 mg is appropriate if HbA1c remains above target on 10 mg, given that adult data consistently show dose-dependent glycemic benefit [9].

Insurance and Access Considerations for Young Adults

The Affordable Care Act allows dependent coverage on parental insurance until age 26, but this requires active enrollment and is not automatic after age 18. Patients who age off Medicaid at 18 in states without expanded Medicaid face the highest risk of coverage gaps.

Eli Lilly and Boehringer Ingelheim, Jardiance's manufacturers, offer the Jardiance Savings Card, which can reduce out-of-pocket costs to as low as $10 per month for commercially insured patients. Generic empagliflozin is not yet available in the United States as of the date of this article. Patients without insurance coverage may require a prior authorization process or a formulary exception, both of which the adult provider will need to initiate [6].

The ADA Standards of Care note that "financial barriers to medication access are a leading driver of treatment discontinuation in young adults with type 2 diabetes" [3]. Identifying a patient's insurance status at the first adult visit, and connecting them with a diabetes care and education specialist, can reduce the risk of a costly gap in SGLT2 inhibitor therapy.

What Adult Providers Need to Know About Youth-Onset T2D

Youth-onset type 2 diabetes is not the same disease as adult-onset type 2 diabetes. The TODAY2 10-year follow-up (N=500 participants with complete data) found that 67 percent of participants had at least one diabetes complication by their late 20s, including hypertension (67%), dyslipidemia (52%), and albuminuria (55%) [12]. These rates are substantially higher than those seen in adults who develop type 2 diabetes at older ages with similar disease duration.

Adult providers who receive a transferred 18-year-old on empagliflozin should not assume this patient has "mild" or "early" disease simply because of age. Complication screening should match the ADA's recommendations for high-risk type 2 diabetes patients, not a standard new-patient schedule.

Empagliflozin's cardiovascular benefit, demonstrated in EMPA-REG OUTCOME (N=7,020) where the drug reduced cardiovascular death by 38 percent in adults with established cardiovascular disease [9], has not been established in adolescents. However, the early complication burden seen in TODAY2 argues for aggressive cardiometabolic risk reduction from the moment of adult care entry.

Counseling Points for Patients and Families

Patients and families transitioning from pediatric to adult care benefit from specific, concrete guidance rather than general reassurance.

Key messages to communicate before the transition visit:

• Empagliflozin must be held at least 3 days before any planned surgical procedure. The patient should tell every provider, including dentists and anesthesiologists, that they take this medication [2].
• Symptoms of DKA (nausea, vomiting, abdominal pain) require emergency evaluation even if the home glucose reading looks acceptable.
• Genital itching or discharge should be reported promptly. Most mycotic infections respond to a single-dose fluconazole, but recurrent infections may prompt a dose review.
• Hydration matters. SGLT2 inhibitors increase urinary glucose excretion and can cause mild volume depletion. Athletes and patients in hot climates should increase fluid intake [2].
• Pregnancy and empagliflozin: the FDA label contraindicates empagliflozin during the second and third trimesters due to fetal renal toxicity [2]. Female patients of reproductive age must receive counseling on this before transitioning, and contraceptive planning should be part of the transition visit.