Type 1 Diabetes MellitusNCT07561086
Innovative Insulin Injection Sites Map to Minimize Lipohypertrophy Risk
A study testing Insulin Injection Site Mapping Tool in people with Type 1 Diabetes Mellitus and Lipohypertrophy, run by Helwan University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Lipohypertrophy
- What is being tested?
- Insulin Injection Site Mapping Tool
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Insulin Injection Site Mapping Tool
- Keywords
- Lipohypertrophy, Patient Education, Randomized Controlled Trial, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Injection Site Mapping ToolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Injection Site Mapping and Education Program | 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. Receives: Behavioral: Insulin Injection Site Mapping Tool |
| Standard Diabetes Care for Insulin Injection Technique | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jun 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Eldin Moustafa Hamed, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561086
- Sponsor's protocol ID
- 0307290
- Other IDs
- 00012098
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Minimize the Risk for Insulin Induced Lipohypertrophy and Its Related Consequences: Innovative Insulin Injection Sites Map
- ClinicalTrials.gov ID
- NCT07561086
- Acronym / sponsor ID
- 0307290
- Conditions
- Type 1 Diabetes Mellitus, Lipohypertrophy
- Keywords
- Lipohypertrophy, Patient Education, Randomized Controlled Trial, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Insulin Injection Site Mapping and Education Program | Experimental | Behavioral: Insulin Injection Site Mapping ToolParticipants 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. |
| Standard Diabetes Care for Insulin Injection Technique | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Injection Site Mapping ToolParticipants 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. | Behavioural | Insulin Injection Site Mapping and Education Program |
Primary outcome
Incidence of Insulin-Induced Lipohypertrophy
Time frame: Baseline, 3 months, and 6 months post-intervention
Description: The primary outcome is the incidence of insulin-induced lipohypertrophy at injection sites, assessed by trained clinical evaluation using visual inspection and palpation.
Adherence to Insulin Injection Site Rotation
Time frame: Baseline, 3 months, and 6 months
Assessment of participant adherence to recommended insulin injection site rotation protocol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background● 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin Injection Site Mapping Tool in people with Type 1 Diabetes Mellitus and Lipohypertrophy, run by Helwan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Insulin-Induced Lipohypertrophy (time frame: Baseline, 3 months, and 6 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.