Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care

NCT ID: NCT02271594

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-12-31

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 (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.

Conditions

Insulin Injections and Lipohypertrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Intensive education on injection technique

Group Type: ACTIVE_COMPARATOR

Intensive Training on Best Insulin Injection Technique

Intervention Type: BEHAVIORAL

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 education on injection technique

Group Type: PLACEBO_COMPARATOR

Standard education on injection technique

Intervention Type: BEHAVIORAL

Usual and customary education and training normally provided injecting patients at the center

Interventions

Intensive Training on Best Insulin 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.

Intervention Type: BEHAVIORAL

Standard education on injection technique

Usual and customary education and training normally provided injecting patients at the center

Intervention Type: BEHAVIORAL

Other Intervention Names

Standard education on injection technique

Eligibility Criteria

Inclusion Criteria

1. Patients with DM1 or DM2, diagnosed for more than a year from the time of inclusion

2. Age between 18 and 75 years old, inclusive

3. Treatment by insulin injection using pen injector for at least 1 year - concomitant oral therapy or GLP-1 injections are allowed

4. Self-care (patients must be giving injections to themselves as opposed to getting them by third parties)

5. Presence of LH on structured physical exam (if in doubt, the patient will not be included)

6. Injections performed frequently into the LH (at least once per day)

7. Self-monitoring of blood glucose (SMBG) and willingness to bring meter to every visit for electronic download

8. 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

9. Ability so speak and read English or accompanied by a person who can competently translate for the patient

Exclusion Criteria

1. Pregnancy (declarative)

2. Ongoing participation in another clinical trial

3. Conditions other than diabetes treatment which might cause lipodystrophies (ex: antiretroviral therapy)

4. Medical conditions that may, in the opinion of the PI, influence study results (ex: currently active cancer, uncontrolled endocrine disorder, eating disorders)

5. Current treatments that may, in the opinion of the PI, influence study results (ex: long-term corticosteroids)

6. Other injectable treatment in diabetes (with the exception of GLP-1) such as insulin pumps, syringes

7. Study staff will document the reasons for the exclusion, if any.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ealing Hospital NHS Trust

OTHER

Sponsor Role: collaborator

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace E Vanterpool, RN

Role: PRINCIPAL_INVESTIGATOR

Ealing Hospital, Northwest London NHS Trust

Locations

Ealing Hospital

Middlesex, London, United Kingdom

Countries

United Kingdom

Other Identifiers

DBC-14LIPOINJ02

Identifier Type: -

Identifier Source: org_study_id