Effect of Needle-free Jet Injection of Insulin on Glucose Control and Injection Feelings in Type 1 Diabetic Patients

NCT04094740 | Unknown

• 1 other identifier: JI-EC T1D 2019
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

People with type 1 diabetes need long-term insulin injections. However, needles may cause discomfort or provoke anxiety if the patient has needle phobia, factors that contribute to poor compliance with insulin, especially in younger patients. Use of needle-free technology has been proposed as a strategy to mitigate these problems. There have been few studies on the efficacy of needle-free syringes for patients with type 1 diabetes. To determine the efficacy of needle-free injection of insulin in its patient population, people with type 1 diabetes, we conduct a pilot study to assess glycemic control and injection experience of patients. For the comparator device, we used an insulin pen. The primary objective is to explore whether needle-free syringes are more beneficial to control blood glucose than insulin pens of type 1 diabetes, which the blood sugar fluctuates significantly. The secondary objective is to evaluate the experience and safety of insulin administration by the needle-free injection.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Continuous Glucose Monitoring(CGM)

  CGM reflects the blood glucose fluctuations in the past 2-3 days.

  from baseline to week 4, 12

• changes in serum hemoglobin A1c level

  A1c reflects the average blood glucose level in the past 2-3 months.

  from baseline to week 12

Secondary Outcomes (13)

• Visual Analog Scale

  From baseline to every 2 weeks

• Insulin Treatment Satisfaction Questionnaire

  from baseline to week 2，4，12

• Insulin Treatment Attitude Scale

  from baseline to week 2，4，12

• Insulin Treatment Adherence Questionnaire

  from baseline to week 2，4，12

• Adjusted Diabetes Quality of Life Measure (A-DQOL)

  from baseline to week 2，4，12

Study Arms (3)

Needle-free Jet Injector

EXPERIMENTAL

Subjects will be instructed to use a needle-free syringe to inject insulin during the study period. The dosage and frequency of insulin are determined by the responsible physician according to the patient's condition.

Device: Jet Injector without A Needle

Conventional Insulin Pen

NO INTERVENTION

Patients allocated to the control group will be instructed to use conventional insulin pens to inject insulin. Except for the syringe, all of them are the same as the experimental group.

Routine Care

NO INTERVENTION

Subjects can receive the education provided by health-care professionals and training in the outpatient department and inpatient departments.

Interventions

Jet Injector without A Needle DEVICE

Patients in the experimental group will use a needle - free jet injector to inject insulin, which delivers insulin at a high velocity into subcutaneous tissue and dispenses insulin over a larger area than a syringe.

Needle-free Jet Injector

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report
• Insulin dependence from disease onset
• Older than 12
• The patient's blood glucose is stable after the washout period (insulin dose is less than 30% compared with the last adjustment).

You may not qualify if:

• Recent unstable angina, myocardial infarction, or severe cardiac failure, blood pressure ≥180/100mm Hg, activities of hepatic transaminases \>2.5 times the upper limit of normal and estimated glomerular filtration rate \<30mL/min/1.73m2
• Being pregnant
• Serious mental problems
• Abuse of alcohol or narcotics
• Use of systemic glucocorticoids
• Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xia Li, MD/PHD

  Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia Li, MD/PHD

CONTACT

+86 17373199692; lixia2014@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Endocrinology, Institute of of Metabolism and Endocrinology, Nationa Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital of Central South University

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: October 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2023
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share