Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Lipohypertrophy
Conditions
Brief summary
This is a prospective, post-marketing, single-arm clinical investigation on the effects of optimal insulin injection technique, in conjunction with the use of disposable Becton Dickinson (BD) Micro-Fine Plus 32G pen needles, by Type I and Type II Diabetes Mellitus patients, with or without lipohypertrophy, on clinical outcomes like HbA1c and hypoglycemic events, as well as changes in insulin Total Daily Dose (TDD) and patient's Quality of Life (QoL). During this study, each subject will be trained in the optimal insulin injection technique by personal training as well as by following online video training modules on a specific web-based platform.
Interventions
BEHAVIORALOptimal insulin injection
subjects receive training in optimal injection technique.
Sponsors
Becton, Dickinson and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 1 or type 2 diabetes mellitus; 2. At least 1 year of experience with insulin self-administration; 3. Use of insulin pen for insulin injections. 4. HbA1c \> 7.5 % measured at study entry or maximally 30 days prior to screening. 5. BMI below 40 kg/m2 at study entry. 6. Daily self-control of blood glucose level; 7. Access to the internet for watching video lessons. 8. Only outpatients are eligible for the study. 9. Availability of signed informed consent of the patient for inclusion in the study.
Exclusion criteria
1. Pregnant women or women planning to become pregnant during the time of study, breastfeeding women; 2. Subjects using an insulin pump; 3. Those using treatment with a Glucagon-Like Peptide (GLP)-1 receptor agonists alone; 4. Subjects not fluent in Russian (reading and writing). 5. Patients at high risk for ketoacidosis and/or hyperglycemia. 6. Psychic, physical or any other reasons hampering patient participation in the study (based on the reasonable opinion of the physician-investigator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycemic Control | up to 6 months | Change in HbA1c for subjects from Baseline to 6 months; expressed as theHbA1c% levels at Baseline and 6-months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Total Daily Dose (TDD) | 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 |
| Incidence of Hypoglycemic Events | up to 6 months | 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 |
| Change in Blood Glucose Levels | up to 6 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect on Quality of Life | 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; |
| Change in Needle Re-use | 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). |
| Effect on Lipohypertrophy Areas | up to 6 months | 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. |
| Effect on Behaviour: Injection in Lipohypertrophy Areas | up to 6 months | 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). |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Optimal Insulin Injection Technique | — |
|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 13.3 | — |
| Baseline HbA1c (%), average | 9.2 % of glycated hemoglobin STANDARD_DEVIATION 1.4 | — |
| Baseline Lipohypertrophy: Yes, No Lipohypertrophy absent | 36 Participants | — |
| Baseline Lipohypertrophy: Yes, No Lipohypertrophy present | 46 Participants | — |
| BMI, average | 26.7 kg/m^2 STANDARD_DEVIATION 5.1 | — |
| Diabetes Type: Type I, Type II Type I Diabetes Mellitus | 57 Participants | — |
| Diabetes Type: Type I, Type II Type II Diabetes Mellitus | 25 Participants | — |
| Insulin therapy duration, average (years) | 13.2 years STANDARD_DEVIATION 11.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Russia | 82 Participants | — |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 56 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 90 |
| other Total, other adverse events | 5 / 90 |
| serious Total, serious adverse events | 4 / 90 |
Outcome results
Primary
Change in Glycemic Control
Change in HbA1c for subjects from Baseline to 6 months; expressed as theHbA1c% levels at Baseline and 6-months
Time frame: up to 6 months
Population: Only participants who completed the study have been analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Optimal Insulin Injection Technique | Change in Glycemic Control | HbA1c at Baseline | 8.99 % of glycated hemoglobin | Standard Deviation 1.37 |
| Optimal Insulin Injection Technique | Change in Glycemic Control | HbA1c at 6-months follow up | 8.20 % of glycated hemoglobin | Standard Deviation 1.1 |
Secondary
Change in Blood Glucose Levels
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Optimal Insulin Injection Technique | 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 |
| Optimal Insulin Injection Technique | 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 |
| Optimal Insulin Injection Technique | 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 |
Secondary
Change in Insulin Total Daily Dose (TDD)
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
Time frame: up to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Optimal Insulin Injection Technique | Change in Insulin Total Daily Dose (TDD) | TDD Insulin at Baseline | 49.5 units | Standard Deviation 24.1 |
| Optimal Insulin Injection Technique | Change in Insulin Total Daily Dose (TDD) | TDD Insulin at 3-months follow up | 49 units | Standard Deviation 24.1 |
| Optimal Insulin Injection Technique | Change in Insulin Total Daily Dose (TDD) | TDD Insulin at 6-months follow up | 51.2 units | Standard Deviation 26.7 |
Secondary
Incidence of Hypoglycemic Events
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
Time frame: up to 6 months
Population: Data are expressed as overall (all participants) and split per type of Diabetes (Type I or Type II)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Optimal Insulin Injection Technique | Incidence of Hypoglycemic Events | Incidence of hypoglycemic events at Baseline (Type I DM) | 74.42 events per person-year |
| Optimal Insulin Injection Technique | Incidence of Hypoglycemic Events | Incidence of hypoglycemic events at 3-months follow up (Type I DM) | 52.66 events per person-year |
| Optimal Insulin Injection Technique | Incidence of Hypoglycemic Events | Incidence of hypoglycemic events at 6-months follow up (Type I DM) | 42.62 events per person-year |
| Optimal Insulin Injection Technique | Incidence of Hypoglycemic Events | Incidence of hypoglycemic events at Baseline (overall) | 56.15 events per person-year |
| Optimal Insulin Injection Technique | Incidence of Hypoglycemic Events | Incidence of hypoglycemic events at 3-months follow up (overall) | 36.35 events per person-year |
| Optimal Insulin Injection Technique | Incidence of Hypoglycemic Events | Incidence of hypoglycemic events at 6-months follow up (overall) | 32.28 events per person-year |
| Optimal Insulin Injection Technique | Incidence of Hypoglycemic Events | Incidence of hypoglycemic events at Baseline (Type II DM) | 21.04 events per person-year |
| Optimal Insulin Injection Technique | Incidence of Hypoglycemic Events | Incidence of hypoglycemic events at 3-months follow up (Type II DM) | 7.43 events per person-year |
| Optimal Insulin Injection Technique | Incidence of Hypoglycemic Events | Incidence of hypoglycemic events at 6-months follow-up (Type II DM) | 11.82 events per person-year |
Other Pre-specified
Change in Needle Re-use
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).
Time frame: up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Optimal Insulin Injection Technique | Change in Needle Re-use | Single needle use at Baseline | 4 Participants |
| Optimal Insulin Injection Technique | Change in Needle Re-use | Single needle use at 3-month follow up | 66 Participants |
| Optimal Insulin Injection Technique | Change in Needle Re-use | Single needle use at 6-month follow- up | 73 Participants |
Other Pre-specified
Effect on Behaviour: Injection in Lipohypertrophy Areas
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).
Time frame: up to 6 months
Population: Only participants with lipohypertrophy at Baseline were included in this analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Optimal Insulin Injection Technique | Effect on Behaviour: Injection in Lipohypertrophy Areas | Injection in lipohypertrophy area at 3-months follow up | 1 Participants |
| Optimal Insulin Injection Technique | Effect on Behaviour: Injection in Lipohypertrophy Areas | Injection in lipohypertrophy area at 6-months follow up | 1 Participants |
| Optimal Insulin Injection Technique | Effect on Behaviour: Injection in Lipohypertrophy Areas | Injection in lipohypertrophy area at Baseline | 40 Participants |
Other Pre-specified
Effect on Lipohypertrophy Areas
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.
Time frame: up to 6 months
Population: Only participants with lipohypertrophy at Baseline were included in this analysis
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Optimal Insulin Injection Technique | Effect on Lipohypertrophy Areas | Length lipohypertrophy area at Baseline | 4.13 cm | Standard Deviation 2.63 |
| Optimal Insulin Injection Technique | Effect on Lipohypertrophy Areas | Length lipohypertrophy area at 3-months follow up | 3.61 cm | Standard Deviation 2.16 |
| Optimal Insulin Injection Technique | Effect on Lipohypertrophy Areas | Length lipohypertrophy area at 6-months follow up | 3.18 cm | Standard Deviation 1.8 |
| Optimal Insulin Injection Technique | Effect on Lipohypertrophy Areas | Width lipohypertrophy area at Baseline | 3.69 cm | Standard Deviation 2.47 |
| Optimal Insulin Injection Technique | Effect on Lipohypertrophy Areas | Width lipohypertrophy area at 3-months follow up | 3.17 cm | Standard Deviation 1.88 |
| Optimal Insulin Injection Technique | Effect on Lipohypertrophy Areas | Width lipohypertrophy area at 6-months follow up | 3.07 cm | Standard Deviation 1.92 |
Other Pre-specified
Effect on Quality of Life
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;
Time frame: up to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Optimal Insulin Injection Technique | Effect on Quality of Life | Health State Index Score at Baseline | 0.76 score on a scale | Standard Deviation 0.21 |
| Optimal Insulin Injection Technique | Effect on Quality of Life | Health State Index Score at 6-months follow up | 0.78 score on a scale | Standard Deviation 0.24 |