Diabetes Mellitus, Type 2NCT04007003
An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform
A study testing training in optimal insulin injection technique in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Becton, Dickinson and Company at 9 sites in Belgium.
Trial summary
The study intends to audit the impact of optimal insulin injection technique on clinical parameters and self-care behaviour of insulin treated diabetes patients in a prospective manner with a follow-up of 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- training in optimal insulin injection technique
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 9 sitesBelgium
- Study dates
- 26 Jun 2018to 10 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 Diabetes Mellitus, or Type 2 Diabetes Mellitus
- Injecting insulin for at least 1 year
- Self-managing injection therapy, including daily glucose monitoring
- Access to a device with internet
- Confident in navigating the internet
Who cannot join
- Pregnant or likely to become pregnant during study period
- Impaired cognitive ability which would prevent informed consent
- Syringe only user
- Insulin pump user
- Glucagon-Like Peptide (GLP)-1 receptor agonists therapy only
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Belgium9 sites
Universitair Ziekenhuis Antwerpen
Antwerp
Imeldaziekenhuis
Bonheiden
Universitair Ziekenhuis Brussel
Brussels
UZ Gent
Ghent
Virga Jesse Ziekenhuis
Hasselt
AZ Groeninge
Kortrijk
AZ Nikolaas
Sint-Niklaas
AZ Turnhout
Turnhout
AZ Jan Portaels
Vilvoorde
About this study
The study intends to audit the impact of optimal insulin injection technique on clinical parameters and self-care behaviour of insulin treated diabetes patients in a prospective manner with a follow-up of 6 months. The optimal injection technique is delivered through education via a multimodal tailored approach augmented with a digital 'tailorable' patient learning platform .
The study is conducted in multiple sites across Belgium. Diabetes patients with or without lipohypertrophy will be entered into the audit. The end points will include the impact on use of insulin, long term blood glucose control (HbA1c), hypoglycaemia, glucose variability, needle reuse, patient injection habits and clinician education, training and information inputs.
- Being tested
- training in optimal insulin injection technique
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training in optimal insulin injection techniqueBehavioural
the training will be delivered in person as well as through online training modules via the BD and Me(TM) platform
| Study group | Role | What they receive |
|---|---|---|
| optimal injection technique | Experimental | Subjects will be trained on site regarding optimal insulin injection technique, including avoiding injections in lipohypertrophy areas and proper rotation. Furthermore subjects are provided with access codes to watch online training modules on the Becton Dickinson (BD) and Me(TM) platform Receives: Behavioral: training in optimal insulin injection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Use
Change in Total Daily Dose of insulin for subjects at baseline and after 6 months; expressed as % and units/24 hrs
Measured: up to 6 months
Secondary outcomes (3)
Change in Glycemic Control
Change in HbA1c for subjects at baseline and after 6 months; expressed as % and mmol/mol
Measured: up to 6 months
Incidence of Hypoglycemic Events
Rate of hypoglycemic events requiring 3rd party assistance in 6 months prior to study start (baseline) and during the 6 months of the study
Measured: up to 6 months
Change in Needle Re-Use
Rate of needle re-use by self-reporting at baseline and after 6 months
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start26 Jun 2018
- Primary completion10 Aug 2019
- Study completion10 Aug 2019
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe De Block, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007003
- Sponsor's protocol ID
- LiMo Audit
- Status last verified
- Dec 2019
- First submitted
- 6 Jun 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform
- ClinicalTrials.gov ID
- NCT04007003
- Acronym / sponsor ID
- LiMo Audit
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study intends to audit the impact of optimal insulin injection technique on clinical parameters and self-care behaviour of insulin treated diabetes patients in a prospective manner with a follow-up of 6 months. The optimal injection technique is delivered through education via a multimodal tailored approach augmented with a digital 'tailorable' patient learning platform .
The study is conducted in multiple sites across Belgium. Diabetes patients with or without lipohypertrophy will be entered into the audit. The end points will include the impact on use of insulin, long term blood glucose control (HbA1c), hypoglycaemia, glucose variability, needle reuse, patient injection habits and clinician education, training and information inputs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| optimal injection technique | Experimental | Behavioral: training in optimal insulin injection techniqueSubjects will be trained on site regarding optimal insulin injection technique, including avoiding injections in lipohypertrophy areas and proper rotation. Furthermore subjects are provided with access codes to watch online training modules on the Becton Dickinson (BD) and Me(TM) platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 Diabetes Mellitus, or Type 2 Diabetes Mellitus
- Injecting insulin for at least 1 year
- Self-managing injection therapy, including daily glucose monitoring
- Access to a device with internet
- Confident in navigating the internet
Key exclusion criteria (5 listed)
- Pregnant or likely to become pregnant during study period
- Impaired cognitive ability which would prevent informed consent
- Syringe only user
- Insulin pump user
- Glucagon-Like Peptide (GLP)-1 receptor agonists therapy only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| training in optimal insulin injection techniquethe training will be delivered in person as well as through online training modules via the BD and Me(TM) platform | Behavioural | optimal injection technique |
Primary outcome
Change in Insulin Use
Time frame: up to 6 months
Change in Total Daily Dose of insulin for subjects at baseline and after 6 months; expressed as % and units/24 hrs
3 secondary outcomes
Change in Glycemic Control
Time frame: up to 6 months
Incidence of Hypoglycemic Events
Time frame: up to 6 months
Change in Needle Re-Use
Time frame: up to 6 months
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe De Block, MD principal investigator
University Hospital, Antwerp
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training in optimal insulin injection technique in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Becton, Dickinson and Company at 9 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin Use (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.