Open-label or unblinded (moderate): Open-label design

No power calculation reported (low): No power calculation reported

Needle-free injection resulted in significantly greater reduction in fasting plasma glucose compared to conventional pen (7.24±1.65 vs 5.82±1.96 mmol/L decrease, p<0.05), demonstrating superior efficacy in achieving fasting glycemic control.

The 2-hour postprandial glucose decreased significantly more with needle-free injection than conventional pen (8.65±2.99 vs 6.68±2.70 mmol/L reduction, p<0.05), indicating better post-meal glucose control.

Time in target glucose range (3.9-10.0 mmol/L) was significantly higher with needle-free injection (83.62±6.21% vs 76.83±11.66%, p=0.006), indicating superior overall glycemic control.

Mean amplitude of glycemic excursions (MAGE) was significantly lower with needle-free injection (2.24±0.86 vs 2.68±0.81 mmol/L, p=0.016) and largest amplitude (LAGE) was also reduced (4.28±1.12 vs 4.94±1.29 mmol/L, p=0.032), demonstrating reduced glucose fluctuations.

Serum 1,5-AG levels increased significantly more with needle-free injection (15.49±12.51 vs 9.66±5.58 μmol/L, p<0.05), indicating better short-term glycemic control and reduced postprandial glucose spikes.

Patients using needle-free injection reached glycemic targets significantly faster than those using conventional pens (1.88±1.36 vs 2.94±1.59 days, p<0.05), demonstrating faster therapeutic response.

Hypoglycemia occurred in 4 patients (12.5%) in the needle-free group vs 8 patients (25.8%) in the conventional pen group, but this difference was not statistically significant (p=0.179). No severe hypoglycemia events occurred in either group.

Total injection-site adverse reactions (bleeding, bruising, redness, swelling) were significantly lower with needle-free injection (18.8% vs 56.1%, p=0.006), with notably fewer bleeding and bruising events.

Pain scores on an 11-point scale were substantially lower with needle-free injection (0.91±1.55 vs 3.77±1.99, p<0.001), with nearly 90% of needle-free users reporting mild pain (0-3) compared to moderate pain in the conventional pen group.

Treatment satisfaction scores were significantly higher with needle-free injection (8.13±1.36 vs 3.45±1.89 on 0-10 scale, p<0.001), with approximately 80% of needle-free users reporting high satisfaction.

Daily insulin requirements were comparable between needle-free injection and conventional pen groups (p>0.05), indicating similar insulin doses were needed despite better glycemic control with needle-free delivery.

QS-P needle-free injector delivering insulin via pressure jet mechanism at 4-6mm depth. Used for basal-bolus insulin regimen with degludec once daily and aspart before meals.

Positive: 9; Negative: 0; No effect: 2; Mixed: 0

Extracted 11 outcome signals across the study

Needle-free injection consistently showed significant benefits across all major glycemic outcomes (FPG, 2hPPG, 1,5-AG, TIR, glycemic variability) and patient-centered outcomes (pain, satisfaction, adverse reactions) compared to conventional pen. No negative outcomes identified.

↓ Fasting plasma glucose (mean reduction 7.24 mmol/L in NFI vs 5.82 mmol/L in CIP, p<0.05)

↓ Postprandial glucose (mean reduction 8.65 mmol/L in NFI vs 6.68 mmol/L in CIP, p<0.05)

Mostly intermediate or surrogate outcomes

Needle-free insulin injection achieved significantly better glycemic control than conventional insulin pens during short-term intensive therapy

Glucose variability was reduced with needle-free injection, as shown by higher time in range and lower glycemic excursion amplitudes

Needle-free devices caused substantially less injection pain and improved patient satisfaction without increasing hypoglycemia risk

Wang J, Liu Z, Jiao L, et al. Efficacy and safety of needle-free injection in patients with type 2 diabetes mellitus undergoing intensive insulin therapy: a randomized controlled trial based on the flash glucose monitoring system. Front Endocrinol (Lausanne). 2026;16:1652388. doi:10.3389/fendo.2025.1652388

Very short study duration (12 days) limits understanding of long-term effectiveness and sustainability

Small sample size (63 participants) from single hospital reduces generalizability

Conducted only in hospitalized patients, unclear if results apply to outpatient settings

Open-label design may have influenced subjective outcomes like pain and satisfaction

A 12-day study in 63 hospitalized type 2 diabetes patients found that needle-free insulin injection achieved better blood sugar control, reduced glucose swings, and caused less pain than conventional insulin pens.

↑ Time in range (83.6% in NFI vs 76.8% in CIP, p<0.01)

The American Diabetes Association's clinical practice guidelines provide evidence-based recommendations for pharmacologic approaches to glycemic treatment, including intensive insulin therapy regimens for patients with type 2 diabetes who have significantly elevated HbA1c or inadequate control on oral medications.

ADA Standards of Care in Diabetes—2024: Insulin and Other Injectable Medications

The Centers for Disease Control and Prevention provides patient education resources about different insulin delivery methods and routines, including information about proper injection techniques and managing diabetes with insulin therapy.

The FDA provides regulatory information and guidance on insulin delivery devices, including conventional insulin pens and newer delivery technologies, outlining safety and efficacy standards for diabetes treatment devices.

American Diabetes Association resource matched by keyword relevance (type 2 diabetes)

A Guide for People with Type 2 Diabetes | American Diabetes Association

This updated algorithm provides evidence-based visual guidance in graphic algorithms and a summary of evidence and considerations to assist health care professionals with the diagnosis and management of adults with prediabetes and type 2 diabetes in shared decision-making to improve care.

AACE Consensus Statement: Algorithm for Management of Adults with Type 2 Diabetes – 2026 Update | American Association of Clinical Endocrinology

This new algorithm provides concise guidance to assist health care professionals with clinical decision-making for the management of persons with type 2 diabetes mellitus and related comorbidities and complications.

AACE Releases 2023 Type 2 Diabetes Management Algorithm to Support Clinical Decision Making | American Association of Clinical Endocrinology

Abaloparatide followed by alendronate treatment may improve bone mineral density (BMD) in women with postmenopausal osteoporosis and type 2 diabetes (T2D), according to study results presented at the AACE 28th Annual Scientific & Clinical Congress.

Abaloparatide Followed by Alendronate Shows Promising Results for Women With Osteoporosis, T2D | American Association of Clinical Endocrinology

The cardiovascular and renal effects of treatment with canagliflozin in patients with type 2 diabetes are more prominent in patients not taking metformin compared with patients treated with canagliflozin as an add-on to metformin, according to data from the CANVAS (CANagliflozin cardioVascular Assessment Study) Program presented at the AACE 28th Annual Scientific & Clinical Congress.

Cardiovascular Effects of Canagliflozin Vary According to Concomitant Metformin Use | American Association of Clinical Endocrinology

Efficacy and Safety of Luseogliflozin in Patients with Type 2 Diabetes Mellitus: An Umbrella Review of Systematic Reviews.

Effect of needle-free injection on psychological insulin resistance and insulin dosage in patients with type 2 diabetes.

Comparative Efficacy and Safety of Ecnoglutide in Type 2 Diabetes: A Systematic Review and Meta-Analysis.

Needle-free injection of basal insulin improves fasting glucose variability as assessed by continuous glucose monitoring in T2DM: a prospective randomized multicenter open-label crossover study.

Efficacy and Safety of a Diabetic Low Glycemic Load Kit With Standard Care in Patients With Type 2 Diabetes: An Open-Label Randomized Pilot Study.

Includes self-reported outcomes (moderate): Self-reported outcomes used

Limited population scope (moderate): Narrow population scope

No post-intervention follow-up (moderate): 0 weeks of follow-up after treatment ended

Open-label or unblinded study (moderate): Open-label design

Needle-free insulin injection improves blood sugar control and reduces pain in hospitalized type 2 diabetes patients

This study compared needle-free insulin injectors to traditional insulin pens in hospitalized people with type 2 diabetes needing intensive insulin therapy. After about 12 days, those using needle-free devices had better blood sugar control, less glucose variability, faster achievement of target levels, fewer injection-site problems, less pain, and higher satisfaction without increased low blood sugar episodes.

This was a very short study in a hospital setting with intensive monitoring that may not reflect real-world outpatient use. The open-label design means participants and staff knew which device was being used, which could affect subjective outcomes like pain and satisfaction ratings. Longer studies are needed to determine if these benefits persist over months or years and whether needle-free devices improve long-term adherence and outcomes. The study also didn't assess cost-effectiveness or device availability issues.

Needle-free insulin injection compared to conventional insulin pens in hospitalized type 2 diabetes patients

This study enrolled hospitalized adults aged 18-70 with type 2 diabetes requiring intensive insulin therapy, including newly diagnosed patients with HbA1c ≥9% or FPG ≥11.1 mmol/L, or those with persistent poor control despite 3 months of oral medications. Average participants were in their early 40s, overweight, and had moderately high baseline glucose levels.

Needle-free insulin injection improves blood sugar control and reduces pain in hospitalized type 2 diabetes patients

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