- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02271594
Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care
Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care: A Randomized, Prospective, Controlled Study in Ealing, United Kingdom
Study Overview
Status
Conditions
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 randomized to the 'LH+ Intervention' arm and 95 patients randomized to the 'LH+ Standard Care' arm. LH+ refers to the presence of clinically-confirmed LH about which there is little or no doubt as to its presence. The study takes place over 4 clinic visits, which form part of their usual clinical visits (spaced at 3-month intervals in Ealing). Each visit is described below.
INTERVENTION The intervention consists of instructing patients in whom LH is detected and who are currently injecting into it to move injections to non-LH areas; reducing insulin doses initially by 10-20% to avoid hypoglycaemia and then titrating to target control; instructing these patients to correctly rotate sites (leaving 1 cm between injection punctures and allowing used sites to heal for 2-4 weeks before injecting in them again); instructing these patients to forego needle reuse; and instructing these patients to switch to 4 mmx32G needles. A battery of tools (described below) will be used to deliver and reinforce this training, including frequent contact by phone or other electronic means after the initial training.
CONTROL Standard care means affording the patients randomized to the control arm the customary education and follow-up usually given at the centre. This would include appraising them of the presence of LH (if they were not previously aware) and stating that injections should not be given into that area. The training approach, tools and intensive follow-up given the Intervention arm patients will not be given to the Controls. Additionally, at their return visit (3 and 6 months), Control patients will be asked if they did indeed change their injection habits (e.g. stopped injecting into LH) since entering the study. Those who did and those who did not will be analysed separately to see if there is a difference in outcomes and both groups will be compared to the Intervention arm patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London
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Middlesex, London, United Kingdom, UB1 3HW
- Ealing Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention
Intensive education on injection technique
|
The intervention consists of instructing patients in whom LH is detected and who are currently injecting into it to move injections to non-LH areas; reducing insulin doses initially by 10-20% to avoid hypoglycaemia and then titrating to target control; instructing these patients to correctly rotate sites (leaving 1 cm between injection punctures and allowing used sites to heal for 2-4 weeks before injecting in them again); instructing these patients to forego needle reuse; and instructing these patients to switch to 4 mmx32G needles.
A battery of tools (described below) will be used to deliver and reinforce this training, including frequent contact by phone or other electronic means after the initial training.
Other Names:
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Placebo Comparator: Control
Standard education on injection technique
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Usual and customary education and training normally provided injecting patients at the center
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 6 months
|
The mean HbA1c from baseline to be compared to six months
|
6 months
|
Blood Glucose (BG) Values
Time Frame: 6 months
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Number of BG values within target range
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6 months
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Hypoglycemia Reactions
Time Frame: 6 months
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Number and severity of hypoglycemic reactions
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Daily Dose (TDD) of Insulin
Time Frame: 6 months
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The mean TDD from baseline to be compared to six months
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6 months
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Health Care Costs
Time Frame: 6 months
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The mean health care costs from baseline to be compared to six months
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Grace E Vanterpool, RN, Ealing Hospital, Northwest London NHS Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DBC-14LIPOINJ02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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