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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Mersa Matrouh
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Marsá Maţrūḩ, Mersa Matrouh, Egipt, 51511
- Matruh General Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Incidence of Insulin-Induced Lipohypertrophy
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- ● 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
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 0307290
- 00012098 (Inny identyfikator: (IRB))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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