Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care

• Sponsor: Becton, Dickinson and Company (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02271594
• Collaborator: Ealing Hospital NHS Trust (Other)
• Enrollment: 31
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Insulin Injections and Lipohypertrophy	Behavioral: Intensive Training on Best Insulin Injection Technique; Behavioral: Standard education on injection technique	N/A

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

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care: A Randomized, Prospective, Controlled Study in Ealing, United Kingdom
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Intensive education on injection technique	Behavioral: 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.; Other Names: Standard education on injection technique
Placebo Comparator: Control Standard education on injection technique	Behavioral: Standard education on injection technique; Usual and customary education and training normally provided injecting patients at the center

Outcome Measures

Primary Outcome Measures

1. HbA1c [6 months]

   The mean HbA1c from baseline to be compared to six months

2. Blood Glucose (BG) Values [6 months]

   Number of BG values within target range

3. Hypoglycemia Reactions [6 months]

   Number and severity of hypoglycemic reactions

Secondary Outcome Measures

1. Total Daily Dose (TDD) of Insulin [6 months]

   The mean TDD from baseline to be compared to six months

2. Health Care Costs [6 months]

   The mean health care costs from baseline to be compared to six months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ealing Hospital	Middlesex	London	United Kingdom	UB1 3HW

Sponsors and Collaborators

• Becton, Dickinson and Company
• Ealing Hospital NHS Trust

Investigators

• Principal Investigator: Grace E Vanterpool, RN, Ealing Hospital, Northwest London NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Becton, Dickinson and Company
• ClinicalTrials.gov Identifier: NCT02271594
• Other Study ID Numbers: DBC-14LIPOINJ02
• First Posted: Oct 22, 2014
• Last Update Posted: Jun 9, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Insulin

Study Results

Participant Flow

Arm/Group Title	Intensive Training	Standard Care
Arm/Group Description	The intervention consists of instructing patients in whom lipohypertrophy (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 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.
Period Title: Overall Study
STARTED	19	12
COMPLETED	0	0
NOT COMPLETED	19	12

Baseline Characteristics

Arm/Group Title	Intensive Training	Standard Care	Total
Arm/Group Description	The intervention consists of instructing patients in whom lipohypertrophy (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 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.	Total of all reporting groups
Overall Participants	19	12	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52 (12)	53 (13)	52 (12)
Sex: Female, Male (Count of Participants)
Female	7 36.8%	7 58.3%	14 45.2%
Male	12 63.2%	5 41.7%	17 54.8%

Outcome Measures

1. Primary Outcome

Title	HbA1c
Description	The mean HbA1c from baseline to be compared to six months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study terminated prior to study endpoint; no 6-month data were collected

Arm/Group Title	Intensive Training	Standard Care
Arm/Group Description	The intervention consists of instructing patients in whom lipohypertrophy (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 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.
Measure Participants	0	0

2. Primary Outcome

Title	Blood Glucose (BG) Values
Description	Number of BG values within target range
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Intervention	Control
Arm/Group Description	Intensive education on injection technique 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.	Standard education on injection technique Standard education on injection technique: Usual and customary education and training normally provided injecting patients at the center
Measure Participants	0	0

3. Primary Outcome

Title	Hypoglycemia Reactions
Description	Number and severity of hypoglycemic reactions
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Not recorded

Arm/Group Title	Intensive Training	Standard Care
Arm/Group Description	The intervention consists of instructing patients in whom lipohypertrophy (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 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.
Measure Participants	0	0

4. Secondary Outcome

Title	Total Daily Dose (TDD) of Insulin
Description	The mean TDD from baseline to be compared to six months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Not recorded

Arm/Group Title	Intensive Training	Standard Care
Arm/Group Description	The intervention consists of instructing patients in whom lipohypertrophy (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 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.
Measure Participants	0	0

5. Secondary Outcome

Title	Health Care Costs
Description	The mean health care costs from baseline to be compared to six months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Not recorded

Arm/Group Title	Intensive Training	Standard Care
Arm/Group Description	The intervention consists of instructing patients in whom lipohypertrophy (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 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.
Measure Participants	0	0

Adverse Events

Time Frame	18 months
Arm/Group Title	Intensive Training		Standard Care
Arm/Group Description	The intervention consists of instructing patients in whom lipohypertrophy (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. 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%		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.
All Cause Mortality
	Intensive Training		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/12 (0%)
Serious Adverse Events
	Intensive Training		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Intensive Training		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.