Plain English Summary
Background and study aims
Diabetes is a life-long condition where a person is unable to control their blood sugar levels. There are two main types of diabetes. In type 1 diabetes the body is unable to produce a hormone called insulin, which is responsible for breaking down glucose and turning it into energy. In type 2 diabetes the body either does not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Insulin therapy is an essential part of treatment for many patients with both forms of diabetes. Patients can experience a range of issues when injecting insulin, resulting from improper technique and, ultimately, resulting in poor blood sugar control. The aim of this study is to find out whether patients who receive appropriate injection technique training and a supply of the required number of short insulin pen needles would achieve significantly greater blood sugar control and improved tolerability to injecting insulin compared with those who do not receive training or a supply of short insulin pen needles.
Who can participate?
Diabetic patients who inject insulin multiple times each day.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive structured training on the correct way to inject insulin and are provided with 4-mm needles for insulin injection pens based on the “one needle per injection” principle. Those in the second group receive structured training on the correct way to inject insulin but supply their own needles for their insulin injection pens. Those in the third group do not receive any training and supply their own needles for their insulin injection pens. All participants attend clinic visits at the start of the study and three and six months later to have blood samples taken to assess their blood sugar control.
What are the possible benefits and risks of participating?
Participants who receive the training may benefit from being able to better control their blood sugar as they feel more able to inject insulin. There is a small risk of pain or bruising from blood testing.
Where is the study run from?
Moscow Regional Research and Clinical Institute (Russia)
When is the study starting and how long is it expected to run for?
April 2013 to January 2014
Who is funding the study?
Moscow Regional Research and Clinical Institute (Russia)
Who is the main contact?
Professor Inna V. Misnikova
inna-misnikova@mail.ru
Trial website
Contact information
Type
Public
Primary contact
Prof Inna V. Misnikova
ORCID ID
Contact details
Moscow Regional Research and Clinical Institute
61/2 Shepkina Street
Moscow
129110
Russian Federation
+7 495 688 95 93
inna-misnikova@mail.ru
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomized controlled trial to assess the impact of proper insulin injection technique training on glycemic control
Acronym
Study hypothesis
Patients who receive appropriate injection technique training and a supply of the required number of short insulin pen needles would achieve significantly greater glycemic control and improved tolerability compared with those who did not receive training or a supply of short insulin pen needles.
Ethics approval
Local ethics committee of Moscow Regional Research and Clinical Institute, 13/06/2013, ref: 3
Study design
Single-centre randomized parallel open controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Type 1 and Type 2 diabetes
Intervention
Participants are randomised to one of three groups using a table with random numbers generated by Statistika software.
Group 1: Patients with type 1 or 2 DM receiving multiple injections, who had structured training on the correct injection technique and were provided with 4-mm needles for insulin injection pens based on the “one needle per injection” principle
Group 2: Patients with type 1 or 2 DM receiving multiple injections, who had structured training on the correct injection technique but who supplied their own needles for insulin injection pens
Group 3 (control): Patients with type 1 or 2 DM receiving multiple injections, who did not have structured training on the correct injection technique and who supplied their own needles for insulin injection pens
All participants attend a total of 3 clinical visits (baseline visit [Days 1–5], month 3, and month 6) and 4 telephone follow-ups (month 1, 2, 4, and 5) over the 6-month study period..
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Blood glucose control is measured using the A1C test at baseline and 6 months
2. Fasting plasma glucose (FPG) is measured using the HemoCue® Glucose 201+ point-of-care glucometer (HemoCue AB, Angelholm, Sweden) at baseline and 6 months
Secondary outcome measures
1. Proportion of patients with A1C >9% is determined by A1C test performed using DCA Vantage Analyzer (Siemens Healthcare Diagnostics Inc., Malvern, PA, USA) at 6 months
2. Changes in insulin total daily dose (TDD), the frequency of needle reuse, and length of needle used before and after training is assessed by the investigator at study visits 1 and 6
3. Injection-related adverse events (AEs) are assessed by the investigator at each clinic visit. Visual examination and palpation of insulin injection sites to reveal LH and/or bruising was performed at baseline and the final study visit; patients were also questioned on the frequency of injection-related pain and bruising during these visits
Overall trial start date
22/04/2013
Overall trial end date
01/01/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of T1DM or T2DM
2. Aged 18 to 70 years
3. On multiple dose injection therapy (3 injections of prandial and 1 to 2 injections of basal insulin daily, prescribed as a pen injection and initiated at least 1 month before study entry)
4. Deemed ready to strictly adhere to the study protocol and scheduled physician visits
5. Provided written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Presence of skin and soft tissue infections at the area of insulin injection
2. History of psychiatric disorders, mental deficiency, or language barrier that could adversely affect interactions with the treating physician in terms of achieving study objectives
Recruitment start date
01/07/2013
Recruitment end date
01/12/2013
Locations
Countries of recruitment
Russian Federation
Trial participating centre
Moscow Regional Research and Clinical Institute
61/2 Shepkina Street
Moscow
129110
Russian Federation
Sponsor information
Organisation
Moscow Regional Research and Clinical Institute
Sponsor details
61/2 Shepkina Street
Мoscow
129110
Russian Federation
Sponsor type
Hospital/treatment centre
Website
Organisation
Becton Dickenson Diabetes Care
Sponsor details
1 Becton Drive
Franklin Lakes
07417
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Moscow Regional Research and Clinical Institute
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
A publication in a high-impact peer-reviewed journal is planned for 2017.
The data were previously presented in 2016: Misnikova IV, Gubkin VA, Dreval AV, Lakeeva, TS. The role of proper insulin injection technique training in achieving good glycemic control. Oral presentation at: American Diabetes Association 76th Scientific Sessions, June 10–14, 2016, New Orleans, LA, USA.
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list