Innovative Insulin Injection Sites Map to Minimize Lipohypertrophy Risk

NCT07561086 | Completed DMC

• 2 other identifiers: 030729000012098
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus; Lipohypertrophy

Keywords

Lipohypertrophy; Patient Education; Randomized Controlled Trial; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Insulin Injection Site Mapping Tool BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Matruh General Hospital

Marsá Maţrūḩ, Mersa Matrouh, 51511, Egypt

Location

Related Publications (1)

• ● 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

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is an open-label randomized controlled trial. No masking is applied to participants, care providers, or investigators due to the nature of the intervention. Participants and care providers are aware of group allocation. Participants in the intervention group receive an evidence-based insulin injection site mapping tool, while participants in the control group receive standard verbal instructions on insulin injection technique. Outcome assessment is intended to be conducted independently to minimize measurement bias; however, no additional formal blinding procedures are implemented. The open-label design is appropriate given the educational and behavioral nature of the intervention, which requires active participant engagement and provider instruction to improve adherence to correct insulin injection practices and reduce the risk of lipohypertrophy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Psychiatric and mental Health Nursing

Model Details: This study is designed as a parallel-group randomized controlled trial. Participants are randomly assigned in an allocation ratio to either the intervention group or the control group. The study compares the effects of an evidence-based insulin injection site mapping tool versus standard care on preventing insulin-induced lipohypertrophy and improving related clinical outcomes. The intervention group receives a structured insulin injection site mapping tool that includes standardized visual diagrams and written guidance to support systematic rotation of injection sites, along with brief educational reinforcement to improve adherence to the protocol. The control group receives routine clinical care, consisting of standard verbal instructions regarding insulin injection site rotation without the use of structured visual mapping or additional educational reinforcement. Both groups are followed over a six-month period to evaluate differences in clinical outcomes, including the inciden

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 1, 2026
• Study Start: June 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

EG (1)