Trial Outcomes & Findings for The Role of Proper Insulin Injection Technique in the Treatment of Diabetes Mellitus (NCT NCT04120974)

NCT ID: NCT04120974

Last Updated: 2024-02-22

Results Overview

Change in HbA1c for subjects from Baseline to 6 months; expressed as theHbA1c% levels at Baseline and 6-months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: up to 6 months
• Results posted on: 2024-02-22

Participant Flow

Participant milestones

Measure	Optimal Insulin Injection Technique Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Overall Study STARTED	90
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Optimal Insulin Injection Technique Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Overall Study Death	1
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Optimal Insulin Injection Technique n=82 Participants Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Age, Continuous	48.2 years STANDARD_DEVIATION 13.3 • n=82 Participants
Sex: Female, Male Female	26 Participants n=82 Participants
Sex: Female, Male Male	56 Participants n=82 Participants
Region of Enrollment Russia	82 Participants n=82 Participants
BMI, average	26.7 kg/m^2 STANDARD_DEVIATION 5.1 • n=82 Participants
Baseline HbA1c (%), average	9.2 % of glycated hemoglobin STANDARD_DEVIATION 1.4 • n=82 Participants
Diabetes Type: Type I, Type II Type I Diabetes Mellitus	57 Participants n=82 Participants
Diabetes Type: Type I, Type II Type II Diabetes Mellitus	25 Participants n=82 Participants
Insulin therapy duration, average (years)	13.2 years STANDARD_DEVIATION 11.4 • n=82 Participants
Baseline Lipohypertrophy: Yes, No Lipohypertrophy present	46 Participants n=82 Participants
Baseline Lipohypertrophy: Yes, No Lipohypertrophy absent	36 Participants n=82 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: Only participants who completed the study have been analyzed

Change in HbA1c for subjects from Baseline to 6 months; expressed as theHbA1c% levels at Baseline and 6-months

Outcome measures

Measure	Optimal Insulin Injection Technique n=82 Participants Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Change in Glycemic Control HbA1c at Baseline	8.99 % of glycated hemoglobin Standard Deviation 1.37
Change in Glycemic Control HbA1c at 6-months follow up	8.20 % of glycated hemoglobin Standard Deviation 1.10

SECONDARY outcome

Timeframe: up to 6 months

Change in Insulin TDD for subjects from Baseline to 3 and 6 months; expressed as the Total Units at Baseline, 3-months and 6-months follow up

Outcome measures

Measure	Optimal Insulin Injection Technique n=82 Participants Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Change in Insulin Total Daily Dose (TDD) TDD Insulin at Baseline	49.5 units Standard Deviation 24.1
Change in Insulin Total Daily Dose (TDD) TDD Insulin at 3-months follow up	49 units Standard Deviation 24.1
Change in Insulin Total Daily Dose (TDD) TDD Insulin at 6-months follow up	51.2 units Standard Deviation 26.7

SECONDARY outcome

Timeframe: up to 6 months

Population: Data are expressed as overall (all participants) and split per type of Diabetes (Type I or Type II)

Incidence rate of hypoglycemic events in the 2-week period at study start (Baseline), a 2-week period approximately 3 months after Baseline, and during a 2 week period around 6 months follow up, expressed in per person-year

Outcome measures

Measure	Optimal Insulin Injection Technique n=82 Participants Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Incidence of Hypoglycemic Events Incidence of hypoglycemic events at 3-months follow up (Type II DM)	7.43 events per person-year
Incidence of Hypoglycemic Events Incidence of hypoglycemic events at 6-months follow-up (Type II DM)	11.82 events per person-year
Incidence of Hypoglycemic Events Incidence of hypoglycemic events at Baseline (overall)	56.15 events per person-year
Incidence of Hypoglycemic Events Incidence of hypoglycemic events at 3-months follow up (overall)	36.35 events per person-year
Incidence of Hypoglycemic Events Incidence of hypoglycemic events at 6-months follow up (overall)	32.28 events per person-year
Incidence of Hypoglycemic Events Incidence of hypoglycemic events at Baseline (Type I DM)	74.42 events per person-year
Incidence of Hypoglycemic Events Incidence of hypoglycemic events at 3-months follow up (Type I DM)	52.66 events per person-year
Incidence of Hypoglycemic Events Incidence of hypoglycemic events at 6-months follow up (Type I DM)	42.62 events per person-year
Incidence of Hypoglycemic Events Incidence of hypoglycemic events at Baseline (Type II DM)	21.04 events per person-year

SECONDARY outcome

Timeframe: up to 6 months

Population: Not all participants had BGM data available, this is the reason the number of analyzed participants deviates from the total number analyzed in the study.

Change in average Blood Glucose Levels (measured by a Blood Glucose Meter) of the first 2 weeks after enrolment (Baseline), compared to the average Blood Glucose Levels during 2 weeks around 3 month and the average of 2 weeks Blood Glucose Levels around 6 months; expressed as mmol/L

Outcome measures

Measure	Optimal Insulin Injection Technique n=72 Participants Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Change in Blood Glucose Levels 24-hour blood glucose average during a two-week period at Baseline	10.28 mmol/L Standard Deviation 3.04
Change in Blood Glucose Levels 24-hour blood glucose average during a two-week period at 3-months follow up	11.03 mmol/L Standard Deviation 3.13
Change in Blood Glucose Levels 24-hour blood glucose average during a two-week period at 6-months follow up	11.03 mmol/L Standard Deviation 3.45

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

In the EQ-5D-35L the 5 dimensions are described by 3 problem levels corresponding to subject response choices.

A quality of life score (Health State Index Score) is obtained according to the answers to the questionnaires. The scale runs from 0 to 1, higher scores mean a better quality of life.

Quality of Life scores will be reported at Baseline and at 6 months;

Outcome measures

Measure	Optimal Insulin Injection Technique n=82 Participants Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Effect on Quality of Life Health State Index Score at Baseline	0.76 score on a scale Standard Deviation 0.21
Effect on Quality of Life Health State Index Score at 6-months follow up	0.78 score on a scale Standard Deviation 0.24

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

Rate of needle re-use by self-reporting, expressed as number of participants reporting single-use needles at Baseline and after 3- and 6 months.

Study participants were queried on their injection technique during study follow up visits and it was documented if they responded the use of a new needle for each insulin injection (single-use needles).

Outcome measures

Measure	Optimal Insulin Injection Technique n=82 Participants Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Change in Needle Re-use Single needle use at Baseline	4 Participants
Change in Needle Re-use Single needle use at 3-month follow up	66 Participants
Change in Needle Re-use Single needle use at 6-month follow- up	73 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

Population: Only participants with lipohypertrophy at Baseline were included in this analysis

Sub-group: for subjects with lipohypertrophy areas at enrolment, change in lipohypertrophy size (length and width) from Baseline to 6 months At Baseline, lipohypertrophy areas caused by repeated insulin injections at the same injection location, were measured. These areas were measured again during the 3-month and 6-month follow up visits.

Outcome measures

Measure	Optimal Insulin Injection Technique n=46 Participants Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Effect on Lipohypertrophy Areas Length lipohypertrophy area at Baseline	4.13 cm Standard Deviation 2.63
Effect on Lipohypertrophy Areas Length lipohypertrophy area at 3-months follow up	3.61 cm Standard Deviation 2.16
Effect on Lipohypertrophy Areas Length lipohypertrophy area at 6-months follow up	3.18 cm Standard Deviation 1.80
Effect on Lipohypertrophy Areas Width lipohypertrophy area at Baseline	3.69 cm Standard Deviation 2.47
Effect on Lipohypertrophy Areas Width lipohypertrophy area at 3-months follow up	3.17 cm Standard Deviation 1.88
Effect on Lipohypertrophy Areas Width lipohypertrophy area at 6-months follow up	3.07 cm Standard Deviation 1.92

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

Population: Only participants with lipohypertrophy at Baseline were included in this analysis

Sub-group: for subjects with lipohypertrophy areas at enrolment, change in injection into lipohypertrophy areas from Baseline to 6 months Study participants were queried on their injection technique during study baseline and follow up visits and it was documented if they responded if they inject insulin at a location with lipohypertrophy or at a different location for each injection (rotating).

Outcome measures

Measure	Optimal Insulin Injection Technique n=46 Participants Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Effect on Behaviour: Injection in Lipohypertrophy Areas Injection in lipohypertrophy area at Baseline	40 Participants
Effect on Behaviour: Injection in Lipohypertrophy Areas Injection in lipohypertrophy area at 3-months follow up	1 Participants
Effect on Behaviour: Injection in Lipohypertrophy Areas Injection in lipohypertrophy area at 6-months follow up	1 Participants

Adverse Events

Optimal Insulin Injection Technique

Serious events: 4 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	Optimal Insulin Injection Technique n=90 participants at risk Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Infections and infestations COVID-19	1.1% 1/90 • Number of events 1 • Adverse Events were collected from study enrollment until End of Study (between Baseline and approximately 6-months follow up) Adverse Event collection was systematically collected by study site staff during on-site and telephone follow-up visits. A Clinical Research Associate has conducted a 100% source data verification and reviewed patient medical charts to ensure all Adverse Events were captured in the Case Report Forms.
Infections and infestations COVID-19 pneumonia	1.1% 1/90 • Number of events 1 • Adverse Events were collected from study enrollment until End of Study (between Baseline and approximately 6-months follow up) Adverse Event collection was systematically collected by study site staff during on-site and telephone follow-up visits. A Clinical Research Associate has conducted a 100% source data verification and reviewed patient medical charts to ensure all Adverse Events were captured in the Case Report Forms.
General disorders Death	1.1% 1/90 • Number of events 1 • Adverse Events were collected from study enrollment until End of Study (between Baseline and approximately 6-months follow up) Adverse Event collection was systematically collected by study site staff during on-site and telephone follow-up visits. A Clinical Research Associate has conducted a 100% source data verification and reviewed patient medical charts to ensure all Adverse Events were captured in the Case Report Forms.
Cardiac disorders Coronary artery disease	1.1% 1/90 • Number of events 1 • Adverse Events were collected from study enrollment until End of Study (between Baseline and approximately 6-months follow up) Adverse Event collection was systematically collected by study site staff during on-site and telephone follow-up visits. A Clinical Research Associate has conducted a 100% source data verification and reviewed patient medical charts to ensure all Adverse Events were captured in the Case Report Forms.

Other adverse events

Measure	Optimal Insulin Injection Technique n=90 participants at risk Patients with Type I or Type II Diabetes Mellitus with an HbA1c value \>7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules.
Eye disorders Visual impairment	1.1% 1/90 • Number of events 1 • Adverse Events were collected from study enrollment until End of Study (between Baseline and approximately 6-months follow up) Adverse Event collection was systematically collected by study site staff during on-site and telephone follow-up visits. A Clinical Research Associate has conducted a 100% source data verification and reviewed patient medical charts to ensure all Adverse Events were captured in the Case Report Forms.
Vascular disorders Hypotension	1.1% 1/90 • Number of events 1 • Adverse Events were collected from study enrollment until End of Study (between Baseline and approximately 6-months follow up) Adverse Event collection was systematically collected by study site staff during on-site and telephone follow-up visits. A Clinical Research Associate has conducted a 100% source data verification and reviewed patient medical charts to ensure all Adverse Events were captured in the Case Report Forms.
Skin and subcutaneous tissue disorders Skin ulcer	1.1% 1/90 • Number of events 1 • Adverse Events were collected from study enrollment until End of Study (between Baseline and approximately 6-months follow up) Adverse Event collection was systematically collected by study site staff during on-site and telephone follow-up visits. A Clinical Research Associate has conducted a 100% source data verification and reviewed patient medical charts to ensure all Adverse Events were captured in the Case Report Forms.
Infections and infestations Nasopharyngitis	1.1% 1/90 • Number of events 1 • Adverse Events were collected from study enrollment until End of Study (between Baseline and approximately 6-months follow up) Adverse Event collection was systematically collected by study site staff during on-site and telephone follow-up visits. A Clinical Research Associate has conducted a 100% source data verification and reviewed patient medical charts to ensure all Adverse Events were captured in the Case Report Forms.
Infections and infestations Respiratory tract infection viral	1.1% 1/90 • Number of events 1 • Adverse Events were collected from study enrollment until End of Study (between Baseline and approximately 6-months follow up) Adverse Event collection was systematically collected by study site staff during on-site and telephone follow-up visits. A Clinical Research Associate has conducted a 100% source data verification and reviewed patient medical charts to ensure all Adverse Events were captured in the Case Report Forms.

Additional Information

Sandra van Guldener, Director OUS Clinical Affairs

Becton, Dickinson and Company

Phone: +31646900840

Email: sandra.vanguldener@bd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place