Insulin Injections and LipohypertrophyNCT02271594
Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care
A study testing Intensive Training on Best Insulin Injection Technique and Standard education on injection technique in people with Insulin Injections and Lipohypertrophy, run by Becton, Dickinson and Company at 1 site in United Kingdom.
Trial 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 (LH) in a controlled, prospective study with a follow-up of 6 months, conducted at Ealing Hospital, West London, UK. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insulin Injections and Lipohypertrophy
- What is being tested?
- Intensive Training on Best Insulin Injection Technique and Standard education on injection technique
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care: A Randomized, Prospective, Controlled Study in Ealing, United Kingdom
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 (LH) in a controlled, prospective study with a follow-up of 6 months, conducted at Ealing Hospital, West London, UK. DM patients who have LH and inject into it will be randomized to either switch to normal tissue sites with intensive education as to why and how and use of a 4mm pen needle, or to continue with standard care. The endpoints measured will include the impact on glucose control parameters, consumption of insulin, hypoglycaemia rates, use of health services resources and health care costs
Read the 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.
- Conditions
- Insulin Injections and Lipohypertrophy
- Being tested
- Intensive Training on Best Insulin Injection Technique, Standard education on injection technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Training on Best Insulin Injection TechniqueBehavioural
Also called Standard 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.
Standard education on injection techniqueBehavioural
Usual and customary education and training normally provided injecting patients at the center
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Intensive education on injection technique Receives: Behavioral: Intensive Training on Best Insulin Injection Technique |
| Control | Placebo comparator | Standard education on injection technique Receives: Behavioral: Standard education on injection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The mean HbA1c from baseline to be compared to six months
Measured: 6 months
Blood Glucose (BG) Values
Number of BG values within target range
Measured: 6 months
Hypoglycemia Reactions
Number and severity of hypoglycemic reactions
Measured: 6 months
Secondary outcomes (2)
Total Daily Dose (TDD) of Insulin
The mean TDD from baseline to be compared to six months
Measured: 6 months
Health Care Costs
The mean health care costs from baseline to be compared to six months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Insulin Injections and LipohypertrophyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ealing Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Grace E Vanterpool, RN, Principal investigator, Ealing Hospital, Northwest London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271594
- Sponsor's protocol ID
- DBC-14LIPOINJ02
- Status last verified
- Jun 2021
- First submitted
- 20 Oct 2014
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care: A Randomized, Prospective, Controlled Study in Ealing, United Kingdom
- ClinicalTrials.gov ID
- NCT02271594
- Acronym / sponsor ID
- DBC-14LIPOINJ02
- Conditions
- Insulin Injections and Lipohypertrophy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Ealing Hospital NHS Trust
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Posted 9 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (LH) in a controlled, prospective study with a follow-up of 6 months, conducted at Ealing Hospital, West London, UK. DM patients who have LH and inject into it will be randomized to either switch to normal tissue sites with intensive education as to why and how and use of a 4mm pen needle, or to continue with standard care. The endpoints measured will include the impact on glucose control parameters, consumption of insulin, hypoglycaemia rates, use of health services resources and health care costs
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Intensive Training on Best Insulin Injection TechniqueIntensive education on injection technique |
| Control | Placebo comparator | Behavioral: Standard education on injection techniqueStandard education on injection technique |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| Intensive Training on Best Insulin Injection TechniqueAlso: Standard education on injection techniqueThe 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. | Behavioural | Intervention |
| Standard education on injection techniqueUsual and customary education and training normally provided injecting patients at the center | Behavioural | Control |
Primary outcome
HbA1c
Time frame: 6 months
The mean HbA1c from baseline to be compared to six months
Blood Glucose (BG) Values
Time frame: 6 months
Number of BG values within target range
Hypoglycemia Reactions
Time frame: 6 months
Number and severity of hypoglycemic reactions
2 secondary outcomes
Total Daily Dose (TDD) of Insulin
Time frame: 6 months
Health Care Costs
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Grace E Vanterpool, RN principal investigator
Ealing Hospital, Northwest London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Training on Best Insulin Injection Technique and Standard education on injection technique in people with Insulin Injections and Lipohypertrophy, run by Becton, Dickinson and Company at 1 site in United Kingdom.
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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 9 Jun 2021. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HbA1c (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2021.