Trial Outcomes & Findings for Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care (NCT NCT02271594)

Results Overview

The mean HbA1c from baseline to be compared to six months

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

6 months

Results posted on

2021-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Intensive Training 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 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.
Overall Study STARTED	19	12
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	19	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Intensive Training 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 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.
Overall Study Study closed; recruiting failure	19	12

Baseline Characteristics

Treating Diabetic Lipohypertrophy With Intensive Education Versus Standard Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive Training n=19 Participants 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 n=12 Participants 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 n=31 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 12 • n=5 Participants	53 years STANDARD_DEVIATION 13 • n=7 Participants	52 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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

The mean HbA1c from baseline to be compared to six months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Data were not collected

Number of BG values within target range

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Not recorded

Number and severity of hypoglycemic reactions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Not recorded

The mean TDD from baseline to be compared to six months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Not recorded

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

Outcome measures

Outcome data not reported

Adverse Events

Intensive Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ken Strauss

BD

Phone: 32475380454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place