Status:
TERMINATED
Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care
Lead Sponsor:
Becton, Dickinson and Company
Collaborating Sponsors:
Ealing Hospital NHS Trust
Conditions:
Insulin Injections and Lipohypertrophy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The investigators intend to assess the impact of optimized injection technique on the evolution of clinical parameters in insulin-treated patients with diabetes (DM) who have clinical lipohypertrophy ...
Detailed Description
This is an interventional clinical trial at Ealing Hospital (UK) in patients with DM1 and DM2 treated with insulin for at least 1 year, aged from 18 to 75 years inclusive, with a goal of 95 patients r...
Eligibility Criteria
Inclusion
- Patients with DM1 or DM2, diagnosed for more than a year from the time of inclusion
- Age between 18 and 75 years old, inclusive
- Treatment by insulin injection using pen injector for at least 1 year - concomitant oral therapy or GLP-1 injections are allowed
- Self-care (patients must be giving injections to themselves as opposed to getting them by third parties)
- Presence of LH on structured physical exam (if in doubt, the patient will not be included)
- Injections performed frequently into the LH (at least once per day)
- Self-monitoring of blood glucose (SMBG) and willingness to bring meter to every visit for electronic download
- Willingness to fill out a diary recording any adverse event (e.g. hypoglycaemia, ambulance call out, unscheduled visit to health care facility) or symptoms that occur during the study
- Ability so speak and read English or accompanied by a person who can competently translate for the patient
Exclusion
- Pregnancy (declarative)
- Ongoing participation in another clinical trial
- Conditions other than diabetes treatment which might cause lipodystrophies (ex: antiretroviral therapy)
- Medical conditions that may, in the opinion of the PI, influence study results (ex: currently active cancer, uncontrolled endocrine disorder, eating disorders)
- Current treatments that may, in the opinion of the PI, influence study results (ex: long-term corticosteroids)
- Other injectable treatment in diabetes (with the exception of GLP-1) such as insulin pumps, syringes
- Study staff will document the reasons for the exclusion, if any.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02271594
Start Date
January 1 2015
End Date
December 1 2016
Last Update
June 9 2021
Active Locations (1)
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1
Ealing Hospital
Middlesex, London, United Kingdom, UB1 3HW