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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Mersa Matrouh
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Marsá Maţrūḩ、Mersa Matrouh、エジプト、51511
- Matruh General Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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:
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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.
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介入なし：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:
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Insulin-Induced Lipohypertrophy
時間枠：Baseline, 3 months, and 6 months post-intervention
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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
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Adherence to Insulin Injection Site Rotation
時間枠：Baseline, 3 months, and 6 months
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Assessment of participant adherence to recommended insulin injection site rotation protocol.
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Baseline, 3 months, and 6 months
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- ● 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
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研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
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詳しくは
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