Innovative Insulin Injection Sites Map to Minimize Lipohypertrophy Risk

Strategy for Minimize the Risk for Insulin Induced Lipohypertrophy and Its Related Consequences: Innovative Insulin Injection Sites Map

Background:

Patients on long-term insulin therapy frequently develop a condition called lipohypertrophy (LH), which involves the accumulation of abnormal fatty tissue at insulin injection sites. This condition is caused by repeated injections in the same area and can lead to inconsistent insulin absorption, unpredictable blood sugar levels, and increased risks of hypoglycemia and hyperglycemia. While standard care often includes verbal instructions on site rotation, many patients continue to struggle with technique and develop these complications.

Study Purpose:

This study aims to evaluate the effectiveness of a novel "Insulin Injection Sites Map" (provided in either digital or physical format) compared to standard verbal care. The study seeks to determine if this structured, visual mapping tool helps patients better manage their injection rotation, reduces the occurrence and severity of lipohypertrophy, and ultimately improves glycemic control (as measured by HbA1c and fasting blood glucose).

Study Design:

This is a prospective, randomized controlled trial (RCT) conducted at the outpatient medical clinic of Matrouh General Hospital. The study includes adult participants (aged 18 and older) diagnosed with Type 1 or Type 2 diabetes who have been using insulin therapy for at least six months.

Participants are divided into two groups:

Intervention Group: Patients who receive the novel structured insulin injection sites map and instructions on systematic rotation.

Control Group: Patients who receive routine care, consisting of standard verbal instructions on site rotation without visual mapping aids.

Outcome Measures:

Over a six-month follow-up period, the study monitors and compares both groups on the following key metrics:

Incidence and Severity of Lipohypertrophy: Evaluated through physical inspection and palpation of injection sites for lumps, firmness, or tenderness.

Adherence to Rotation Protocols: Measured using patient logs and site rotation scores to determine if participants are following the recommended rotation sequence.

Glycemic Control: Tracked through clinical monitoring of HbA1c percentages and fasting blood glucose levels to assess the impact of better injection technique on overall diabetes management.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus; Lipohypertrophy
• Intervention / Treatment: Behavioral: Insulin Injection Site Mapping Tool

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mersa Matrouh
    • Marsá Maţrūḩ, Mersa Matrouh, Egypt, 51511
      • Matruh General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years and older.
• Diagnosed with Type 1 or Type 2 diabetes mellitus.
• Currently receiving insulin therapy for a minimum of six months.
• Capable of self-injecting insulin or receiving assistance with injections at least once daily.
• Able and willing to provide informed consent to participate in the study.
• Able to understand and follow the study protocols.

Exclusion Criteria:

• Presence of mental illnesses or severe cognitive impairment that may affect participation.
• Individuals with skin disorders at injection sites (e.g., severe eczema, psoriasis, or infections) that could interfere with the evaluation of lipohypertrophy.
• Women who are pregnant or lactating.
• Participation in another interventional clinical trial within the past three months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin Injection Site Mapping and Education Program; Participants in this arm receive an evidence-based insulin injection site mapping tool designed to support systematic rotation of insulin injection sites and reduce the risk of insulin-induced lipohypertrophy, with the aim of improving glycemic control. Interventions: Provision of an insulin injection site mapping tool (digital or printed format) illustrating recommended rotation patterns; Structured educational sessions on correct insulin injection techniques and site rotation principles; Weekly reinforcement follow-up (e.g., phone calls) to support adherence, address barriers, and reinforce proper injection practices.	Behavioral: Insulin Injection Site Mapping Tool; Participants receive an evidence-based insulin injection site mapping tool designed to guide systematic rotation of insulin injection sites and reduce the risk of insulin-induced lipohypertrophy. The intervention is supported by structured education and follow-up reinforcement.
No Intervention: Standard Diabetes Care for Insulin Injection Technique; Participants in this arm receive standard diabetes care related to insulin injection technique, without additional structured tools or enhanced educational support. Interventions: Routine verbal instructions on insulin injection technique and site rotation as provided in usual clinical practice.; No visual mapping tools, structured education sessions, or follow-up reinforcement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Insulin-Induced Lipohypertrophy	Description: The primary outcome is the incidence of insulin-induced lipohypertrophy at injection sites, assessed by trained clinical evaluation using visual inspection and palpation.	Baseline, 3 months, and 6 months post-intervention
Adherence to Insulin Injection Site Rotation	Assessment of participant adherence to recommended insulin injection site rotation protocol.	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Helwan University

Publications and helpful links

General Publications

• ● Abouzid, M. R., Ali, K., Elkhawas, I., & Elshafei, S. M. (2022). An Overview of Diabetes Mellitus in Egypt and the Significance of Integrating Preventive Cardiology in Diabetes Management. Cureus, 14(7), e27066. https://doi.org/10.7759/cureus.27066 ● Alharbi, T. J., Tourkmani, A. M., Bin Rsheed, A., Al Abood, A. F., & Alotaibi, Y. K. (2021). Sociodemographic and clinical predictors of refractory type 2 diabetes patients. Saudi Medical Journal, 42(2), 181-188. https://doi.org/10.15537/smj.2021.2.25694 ● AlJaber AN, Sales I, Almigbal TH, Wajid S, Batais MA. The prevalence of lipohypertrophy and its associated factors among Saudi patients with type 2 diabetes mellitus. J Taibah Univ Med Sci 2020; 15(3): 224-31. ● American Diabetes Association Professional Practice Committee (2022). 6. Glycemic Targets: Standards of Medical Care in Diabetes-2022. Diabetes care, 45(Suppl 1), S83-S96. https://doi.org/10.2337/dc22-S006 ● American Diabetes Association Professional Practice Committee; 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes-2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S111-S125. https://doi.org/10.2337/dc24-S006 ● Barola, A., Tiwari, P., Bhansali, A., Grover, S., & Dayal, D. (2018). Insulin-Related Lipohypertrophy: Lipogenic Action or Tissue Trauma?. Frontiers in endocrinology, 9, 638. https://doi.org/10.3389/fendo.2018.00638 ● Bavuma, C. M., Musafiri, S., Rutayisire, P. C., Ng'ang'a, L. M., McQuillan, R., & Wild, S. H. (2020). Socio-demographic and clinical characteristics of diabetes mellitus in rural Rwanda: time to contextualize the interventions? A cross-sectional study. BMC endocrine disorders, 20(1), 180. https://doi.org/10.1186/s12902-020-00660-y ● Blanchard, J., Ahmed, S., Clark, B., Sanchez Cotto, L., Rangasamy, S., & Thompson, B. (2024). Design and Testing of a Smartphone Application for Real-Time Tracking of CSII and CGM Site Rotation Compliance in Patients With Type 1 Diabetes. Journal of Diabetes Science and Technology, 18

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Randomized Controlled Trial; Patient Education; Lipohypertrophy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 0307290; 00012098 (Other Identifier: Alexandria University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No