diabetes patients with Lipohypertrophy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes, diagnosed and use insulin more than a year; 2. Treatment by insulin injection using pen injector for at least 1 year – concomitant oral therapy is allowed; 3. Patients inject insulin or insulin analog no less than twice per day; 4. Aged between 18 and 75 years old; 5. HbA1c is between 7%-11%; 6. Self-care (patients must be giving injections to themselves as opposed to getting them by third parties); 7. Presence of LH on structured physical exam and ultrasound; 8. Injections performed frequently into the LH ( injected in LH area before and didnt deliberately avoid injecting in these site); 9. Local patients, can be visited on time; 10. Willing to sign on informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnancy (declarative); 2. Ongoing participation in another clinical trial; 3. Serious neurological diseases or patients with mental disorders lead to have trouble in understanding, memory, and expression; 4. Associated with serious cardiovascular disease, gastrointestinal disease, respiratory diseases and urinary system diseases; 5. Medical conditions other than diabetes treatment which might have caused lipodystrophies (for example: antiretroviral therapy); 6. Medical conditions or current treatments that may, in the opinion of the investigator, influence the interpretation of study results (for example: corticosteroids); 7. Document the reasons for the exclusion, if any.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily consumption of insulin;weight;body mass index;Hypoglycemia;1,5-AG;Mean blood glucose and Glycemic variability;Type of needles used (length);Reuse of needles;Presence and size of LH;Compliance to proposed intervention measures;Evaluation of the costs involved;WHO-5 QOL assessment; | — |
Countries
China
Contacts
Tianjin Medical University Metabolic Diseases Hospital