Diabetes MellitusIHUTNCT01432275
Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study
A study testing ADC blood glucose meter, Comparator blood glucose meter and ADC blood glucose meter with insulin calculator active in people with Diabetes Mellitus, run by Abbott Diabetes Care at 7 sites in United Kingdom.
Trial summary
The aim of this study is to evaluate user preference and ease of use of the FreeStyle InsuLinx system, compared to current methodology, when used at home by subjects with diabetes. Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with comparator meters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- ADC blood glucose meter, Comparator blood glucose meter and ADC blood glucose meter with insulin calculator active
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Sep 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject with Type 1 or 2 diabetes on a bolus regime (U100 insulin), one or more bolus injections per day for at least 6 months;
- Age 18 yrs and above;
- Regularly testing SMBG 3 or more times per day;
- Willingness to test at least 4 times per day.
Who cannot join
- Know to require a bolus injection of more than 50U in a single dose;
- Has previously used either the InsuLinx or assigned comparison meter;
- Participated in structured diabetes management training in the last 6 months
- Is currently on an insulin pump;
- Has concomitant disease that, in the Investigator's opinion, may compromise patient safety;
- Is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management;
- Female subject who is pregnant or planning to become pregnant during the course of the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Tameside Hospital NHS Foundation Trust
Ashton-under-Lyne, OL6 9RW
Ayr Hospital
Ayr, KA6 6DX
Royal United Hospital
Bath, BA1 3NG
Royal Blackburn Hospital
Blackburn, BB2 7PL
North Manchester Diabetes Centre
Crumpsall, M8 5RB
Ipswich Hospital NHS Trust
Ipswich, IP4 5PD
Greenwood & Sneinton Family Medical Centre
Nottingham, NG3 7DQ
About this study
The aim of this study is to evaluate user preference and ease of use of the FreeStyle InsuLinx system, compared to current methodology, when used at home by subjects with diabetes.
Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with comparator meters.
- Conditions
- Diabetes Mellitus
- Being tested
- ADC blood glucose meter, Comparator blood glucose meter, ADC blood glucose meter with insulin calculator active
- Keywords
- Diabetes, SMBG, Insulin calculator
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADC blood glucose meterDevice
Also called Abbott Freestyle InsuLinx
Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.
Comparator blood glucose meterDevice
Also called Roche Accu-Chek Aviva Nano, Lifescan Verio Pro or, Bayer Contour USB
Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.
ADC blood glucose meter with insulin calculator activeDevice
Also called Abbott FreeStyle InsuLinx
Subjects used the FreeStyle InsuLinx with the insulin calculator activated.
| Study group | Role | What they receive |
|---|---|---|
| ADC, Then Comparator, Then ADC With Calculator | Experimental | Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active. Receives: Device: ADC blood glucose meter; Device: Comparator blood glucose meter; Device: ADC blood glucose meter with insulin calculator active |
| Comparator, Then ADC, Then ADC With Calculator | Experimental | Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active. Receives: Device: ADC blood glucose meter; Device: Comparator blood glucose meter; Device: ADC blood glucose meter with insulin calculator active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.
Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.
Measured: 25 days
Secondary outcomes (1)
Preference Questionnaire (Insulin Calculator Not Activated)
Result for the question: "The meter the subject would change to"
Measured: 25 days (results recorded after the two 7 day periods)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shenaz Ramtoola, Principal investigator, Royal Blackburn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432275
- Sponsor's protocol ID
- ADC-PMS-INX-11011
- Acronym
- IHUT
- Status last verified
- Apr 2017
- First submitted
- 9 Sep 2011
- Last updated
- 4 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study
- ClinicalTrials.gov ID
- NCT01432275
- Acronym / sponsor ID
- IHUT / ADC-PMS-INX-11011
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, SMBG, Insulin calculator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Posted 4 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate user preference and ease of use of the FreeStyle InsuLinx system, compared to current methodology, when used at home by subjects with diabetes.
Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with comparator meters.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADC, Then Comparator, Then ADC With Calculator | Experimental | Device: ADC blood glucose meter, Device: Comparator blood glucose meter, Device: ADC blood glucose meter with insulin calculator activeSubject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active. |
| Comparator, Then ADC, Then ADC With Calculator | Experimental | Device: ADC blood glucose meter, Device: Comparator blood glucose meter, Device: ADC blood glucose meter with insulin calculator activeSubject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject with Type 1 or 2 diabetes on a bolus regime (U100 insulin), one or more bolus injections per day for at least 6 months;
- Age 18 yrs and above;
- Regularly testing SMBG 3 or more times per day;
- Willingness to test at least 4 times per day.
Key exclusion criteria (7 listed)
- Know to require a bolus injection of more than 50U in a single dose;
- Has previously used either the InsuLinx or assigned comparison meter;
- Participated in structured diabetes management training in the last 6 months
- Is currently on an insulin pump;
- Has concomitant disease that, in the Investigator's opinion, may compromise patient safety;
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 |
|---|---|---|
| ADC blood glucose meterAlso: Abbott Freestyle InsuLinxSubjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter. | Device | ADC, Then Comparator, Then ADC With Calculator, Comparator, Then ADC, Then ADC With Calculator |
| Comparator blood glucose meterAlso: Roche Accu-Chek Aviva Nano, Lifescan Verio Pro or, Bayer Contour USBSubjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter. | Device | ADC, Then Comparator, Then ADC With Calculator, Comparator, Then ADC, Then ADC With Calculator |
| ADC blood glucose meter with insulin calculator activeAlso: Abbott FreeStyle InsuLinxSubjects used the FreeStyle InsuLinx with the insulin calculator activated. | Device | ADC, Then Comparator, Then ADC With Calculator, Comparator, Then ADC, Then ADC With Calculator |
Primary outcome
Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.
Time frame: 25 days
Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.
1 secondary outcome
Preference Questionnaire (Insulin Calculator Not Activated)
Time frame: 25 days (results recorded after the two 7 day periods)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Shenaz Ramtoola principal investigator
Royal Blackburn Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADC blood glucose meter, Comparator blood glucose meter and ADC blood glucose meter with insulin calculator active in people with Diabetes Mellitus, run by Abbott Diabetes Care at 7 sites in United Kingdom.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 4 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method. (time frame: 25 days). 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 4 Aug 2017.