Diabetes MellitusPhase 4SIGNNCT01713348
Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes
A Phase 4 study testing FreeStyle Navigator and Standard SMBG in people with Diabetes Mellitus, run by Abbott Diabetes Care at 9 sites in United Kingdom.
Trial summary
To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by; 1. regularly checking and understanding Continuous Glucose data \& trend arrows at times other than the standard pre-meal bolus calculation test times and 2. review of their glucose profiles (inc. 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?
- FreeStyle Navigator and Standard SMBG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Oct 2012to Jul 2013
- Phase
- Phase 4
- 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
- Age 18 years and over
- Type 1 diabetes on MDI with bolus injections for >6 months prior to study enrolment or Type 2 diabetes treated with 2 or more insulin injections daily.
- In the investigator's opinion, thought technically capable of using FreeStyle Navigator GM System device.
- HbA1c between 7.5 and 12.0% (58 to 108 mmol/mol) for previous test obtained within 6 months prior to point of enrolment
Who cannot join
- Concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any uncontrolled chronic medical condition
- Female subject is pregnant or planning to become pregnant within the planned study duration. Subjects who become pregnant during the study will be discontinued from the study.
- Currently using / has previously used a Continuous Glucose Monitoring System within the last 6 months.
- Currently using Continuous Subcutaneous Insulin Infusion (CSII)
- Currently using basal/long acting insulin only.
- Participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
- Known allergy to medical grade adhesives
- In the investigators opinion is unsuitable to participate due to any other cause/reason.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Tameside Hospital NHS Foundation Trust
Ashton-under-Lyne, OL6 9RW
Ayr Hospital
Ayr, Ayrshire, KA6 6DX
Royal United Hospital
Bath, BA1 3NG
Birmingham Heartlands Hospital, Diabetes Clinic
City and Borough of Birmingham, B9 5SS
University Hospital of North Durham
Durham, DH1 5TW
Ipswich Hospital NHS Trust
Ipswich, IP4 5PD
St James Hospital,
Leeds, LS9 7TF
Rotherham General Hospital
Rotherham, S60 2UD
Diabetes Centre, New Cross Hospital,
Wolverhampton, WV10 0QP
About this study
To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by;
- regularly checking and understanding Continuous Glucose data \& trend arrows at times other than the standard pre-meal bolus calculation test times and
- review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care Professional (HCP) and adjusting behaviours \& therapy from interpretation of the Continuous Glucose profiles.
- Conditions
- Diabetes Mellitus
- Being tested
- FreeStyle Navigator, Standard SMBG
- Keywords
- CGM, MDI
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle NavigatorDevice
Masked CGM day 1 to 15, unmasked CGM days 15 to 100
Standard SMBGDevice
Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
| Study group | Role | What they receive |
|---|---|---|
| CGM - intervention arm | Experimental | Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. Receives: Device: FreeStyle Navigator |
| SMBG - Control arm | Active comparator | Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. Receives: Device: Standard SMBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range
Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.
Measured: Day 86 to 100 compared to Day 1 to 15
Secondary outcomes (4)
Time in Range
Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.
Measured: Days 86 to 100 intervention arm compared to control arm
Glucose Standard Deviation (SD)
Measured: Day 86 to 100 compared to day 1 to 15
HbA1c (mmol/Mol)
Measured: Day 100 compared to day 1
HbA1c
Measured: Day 100 compared to day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionJul 2013
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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramzi Ajjan, Principal investigator, St James Hospital, Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713348
- Sponsor's protocol ID
- ADC-PMR-APO-12015
- Acronym
- SIGN
- Status last verified
- Feb 2016
- First submitted
- 22 Oct 2012
- Last updated
- 4 Mar 2016
- 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 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes
- ClinicalTrials.gov ID
- NCT01713348
- Acronym / sponsor ID
- SIGN / ADC-PMR-APO-12015
- Conditions
- Diabetes Mellitus
- Keywords
- CGM, MDI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Oct 2012 (estimated)
- Results
- Posted 11 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by;
- regularly checking and understanding Continuous Glucose data \& trend arrows at times other than the standard pre-meal bolus calculation test times and
- review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care Professional (HCP) and adjusting behaviours \& therapy from interpretation of the Continuous Glucose profiles.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM - intervention arm | Experimental | Device: FreeStyle NavigatorFollowing a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off. |
| SMBG - Control arm | Active comparator | Device: Standard SMBGFollowing a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and over
- Type 1 diabetes on MDI with bolus injections for >6 months prior to study enrolment or Type 2 diabetes treated with 2 or more insulin injections daily.
- In the investigator's opinion, thought technically capable of using FreeStyle Navigator GM System device.
- HbA1c between 7.5 and 12.0% (58 to 108 mmol/mol) for previous test obtained within 6 months prior to point of enrolment
Key exclusion criteria (8 listed)
- Concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any uncontrolled chronic medical condition
- Female subject is pregnant or planning to become pregnant within the planned study duration. Subjects who become pregnant during the study will be discontinued from the study.
- Currently using / has previously used a Continuous Glucose Monitoring System within the last 6 months.
- Currently using Continuous Subcutaneous Insulin Infusion (CSII)
- Currently using basal/long acting insulin 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 |
|---|---|---|
| FreeStyle NavigatorMasked CGM day 1 to 15, unmasked CGM days 15 to 100 | Device | CGM - intervention arm |
| Standard SMBGMasked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100 | Device | SMBG - Control arm |
Primary outcome
Time in Range
Time frame: Day 86 to 100 compared to Day 1 to 15
Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.
4 secondary outcomes
Time in Range
Time frame: Days 86 to 100 intervention arm compared to control arm
Glucose Standard Deviation (SD)
Time frame: Day 86 to 100 compared to day 1 to 15
HbA1c (mmol/Mol)
Time frame: Day 100 compared to day 1
HbA1c
Time frame: Day 100 compared to day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ramzi Ajjan principal investigator
St James Hospital, Leeds
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FreeStyle Navigator and Standard SMBG in people with Diabetes Mellitus, run by Abbott Diabetes Care at 9 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 8 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 Mar 2016. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2015). 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?
Time in Range (time frame: Day 86 to 100 compared to Day 1 to 15). 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 Mar 2016.