Type 2 Diabetes MellitusREPLACENCT02082184
An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes
A study testing Sensor Based Glucose Monitoring System and Standard Blood Glucose Monitoring in people with Type 2 Diabetes Mellitus, run by Abbott Diabetes Care at 26 sites in 3 countries.
Trial summary
To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Sensor Based Glucose Monitoring System and Standard Blood Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Mar 2014to Dec 2015
- 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
- Has Type 2 diabetes on insulin therapy for ≥ 6 months and on their current regimen for ≥3 months prior to study entry.
- Their insulin management must be one of the following;
- an injection regimen of prandial insulin at least once daily,
- or, prandial insulin at least once daily plus basal insulin at least once daily,
- or, continuous subcutaneous insulin infusion (CSII) with no plans to change during the study.
- HbA1c result ≥7.5% (58 mmol/mol) and ≤12.0% (108 mmol/mol) on entry to the study.
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- Reports self-testing of blood glucose levels on a regular basis equivalent to a minimum of 10 tests per week, for at least 2 months prior to study entry.
- In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System.
- In the Investigator's opinion the subject is proactive and therefore willing to modify their diabetes management
- Aged 18 years or over.
Who cannot join
- Insulin regimen consists entirely of basal or includes bi-phasic insulin.
- Subject is currently prescribed animal insulin.
- Subject is currently prescribed steroid therapy or is likely to require steroid therapy for any acute or chronic condition during the study.
- Has known allergy to medical grade adhesives.
- Currently participating in another device or drug study that could affect glucose measurements or glucose management.
- Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months.
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- Is planning to use a CGM device at any time during the study.
- Total daily dose of insulin (TDD) is >1.75iu/kg at entry to the study.
- A female subject who is pregnant or planning to become pregnant within the study duration.
- Currently receiving dialysis treatment or planning to receive dialysis during the study.
- Has experienced an acute myocardial infarction within previous 6 months.
- Has a concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition.
- Has a pacemaker or any other neuro stimulators.
- Has experienced any episode of severe hypoglycaemia, requiring third party assistance and/or admission to hospital, in the previous 6 months.
- Has experienced any episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) in the previous 6 months.
- In the investigator's opinion, the subject is considered as unsuitable for inclusion in the study for any other reason.
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
Germany10 sites
Diabetes Zentrum Mergentheim
Bad Mergentheim, 97980
Praris Dr Karin Schlecht
Eisenach, 99817
Diabetologische Schwenpunlet Praxis
Hamburg, 21073
Gemeiusilaftsproxis Fur Junere,
Hamburg, 22607
Vorstandsmitglied Deutsche Diabetes-Hilfe
Hamburg
Hohenzollernring
Münster, 48145
Diabetes Center Quakenbruck
Quakenbrück, 49610
Diabetes Schwerpunktpraxis Loccum
Rehburg-Loccum, 31547
An der Pforte
Rosenheim, 55545
Versdias GmbH
Sulzbach-Rosenberg
France8 sites
CHU Haut Lévêque
Bordeaux, 33604
Hôpital sainte Marguerite
Marseille, 13274
CHU Lapeyronie
Montpellier, 34295
CHU. Nancy
Nancy
Hopital Guillaume et René Laennec
Nantes, 44000
Hospital Lariboisere
Paris, 75475
Hôpital Cochin
Paris, 75679
Hôpital Rangueil
Toulouse, 31059
United Kingdom8 sites
Ayr Hospital
Ayr, Ayrshire, KA6 6DX
Royal United Hospital
Bath, BA1 3NG
FRCPath Life and Health Sciences, Aston University
Birmingham, B4 7ET
University Hospital of North Durham
Durham, DH1 5TW
The Diabetes Centre, Ipswich Hospital NHS Trust
Ipswich, IP4 5PD
St. James University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Diabetes Research, Linda McCartney Centre, Royal Liverpool University Hospital
Liverpool, Cheshire, L7 8XP
Rotherham General Hospital
Rotherham, S60 2UD
About this study
Official title: Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes
To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
- Keywords
- Sensing Technology, Type 2 Diabetes,
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor Based Glucose Monitoring SystemDevice
Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
Standard Blood Glucose MonitoringDevice
Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
| Study group | Role | What they receive |
|---|---|---|
| Sensor Based Glucose Monitoring System | Experimental | Standard system use for 6 months. Followed by open access to the device for 6 months. Receives: Device: Sensor Based Glucose Monitoring System |
| Standard Blood Glucose Monitoring | Active comparator | Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration. Receives: Device: Standard Blood Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c at 6 Months
Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.
Measured: Baseline and Day 194
Secondary outcomes (7)
Time in Range
Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range) using ANCOVA.
Measured: Baseline and Days 194 to 208
Time Spent <70 mg/dL and <55 mg/dL
Difference in time <70 mg/dL and <55 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.
Measured: Baseline and Days 194 to 208
Frequency of Episodes <70 mg/dL and <55 mg/dL
Difference in frequency of episodes <70 mg/dL and <55 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.
Measured: Baseline and Days 194 to 208
Time Spent >180 mg/dL and >240 mg/dL
Difference in time >180 mg/dL and >240mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.
Measured: Baseline and Days 194 to 208
Number of Glucose Measurements Performed
Number of blood glucose fingerstick tests per day by intervention and control group during days 15 to 208. The number of sensor scans performed by the intervention group during days 15 to 208.
Measured: Days 15 to 208
System Utilisation
Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.
Measured: Days 15 to 208
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.
The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).
There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).
The ANCOVA adjusts for baseline DTSQs (status version).
Measured: Baseline and Day 194
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionDec 2015
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Haak, Principal investigator, Research Institute of Diabetes Academy Mergentheim (FIDAM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082184
- Sponsor's protocol ID
- ADC-CI-APO-12018
- Acronym
- REPLACE
- Status last verified
- Apr 2017
- First submitted
- 6 Mar 2014
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rayman G, Kroger J, Bolinder J. Could FreeStyle Libre sensor glucose data support decisions for safe driving? Diabet Med. 2018 Apr;35(4):491-494. doi: 10.1111/dme.13515. Epub 2017 Oct 14.
PubMed 28945936Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Ther. 2017 Jun;8(3):573-586. doi: 10.1007/s13300-017-0255-6. Epub 2017 Apr 11.
PubMed 28401454Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.
PubMed 28000140
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02082184
- Acronym / sponsor ID
- REPLACE / ADC-CI-APO-12018
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Sensing Technology, Type 2 Diabetes,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Posted 14 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensor Based Glucose Monitoring System | Experimental | Device: Sensor Based Glucose Monitoring SystemStandard system use for 6 months. Followed by open access to the device for 6 months. |
| Standard Blood Glucose Monitoring | Active comparator | Device: Standard Blood Glucose MonitoringSubjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has Type 2 diabetes on insulin therapy for ≥ 6 months and on their current regimen for ≥3 months prior to study entry.
- Their insulin management must be one of the following;
- HbA1c result ≥7.5% (58 mmol/mol) and ≤12.0% (108 mmol/mol) on entry to the study.
- Reports self-testing of blood glucose levels on a regular basis equivalent to a minimum of 10 tests per week, for at least 2 months prior to study entry.
- In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System.
Key exclusion criteria (16 listed)
- Insulin regimen consists entirely of basal or includes bi-phasic insulin.
- Subject is currently prescribed animal insulin.
- Subject is currently prescribed steroid therapy or is likely to require steroid therapy for any acute or chronic condition during the study.
- Has known allergy to medical grade adhesives.
- Currently participating in another device or drug study that could affect glucose measurements or glucose management.
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 |
|---|---|---|
| Sensor Based Glucose Monitoring SystemSubjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation. | Device | Sensor Based Glucose Monitoring System |
| Standard Blood Glucose MonitoringSubjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation. | Device | Standard Blood Glucose Monitoring |
Primary outcome
HbA1c at 6 Months
Time frame: Baseline and Day 194
Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.
7 secondary outcomes
Time in Range
Time frame: Baseline and Days 194 to 208
Time Spent <70 mg/dL and <55 mg/dL
Time frame: Baseline and Days 194 to 208
Frequency of Episodes <70 mg/dL and <55 mg/dL
Time frame: Baseline and Days 194 to 208
Time Spent >180 mg/dL and >240 mg/dL
Time frame: Baseline and Days 194 to 208
Number of Glucose Measurements Performed
Time frame: Days 15 to 208
System Utilisation
Time frame: Days 15 to 208
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.
Time frame: Baseline and Day 194
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28945936Rayman G, Kroger J, Bolinder J. Could FreeStyle Libre sensor glucose data support decisions for safe driving? Diabet Med. 2018 Apr;35(4):491-494. doi: 10.1111/dme.13515. Epub 2017 Oct 14.
- Derived from this study: PubMed 28401454Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Ther. 2017 Jun;8(3):573-586. doi: 10.1007/s13300-017-0255-6. Epub 2017 Apr 11.
- Derived from this study: PubMed 28000140Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.
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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.
Thomas Haak principal investigator
Research Institute of Diabetes Academy Mergentheim (FIDAM)
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor Based Glucose Monitoring System and Standard Blood Glucose Monitoring in people with Type 2 Diabetes Mellitus, run by Abbott Diabetes Care at 26 sites in 3 countries.
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 10 inclusion and 16 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, France, 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 14 Apr 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?
HbA1c at 6 Months (time frame: Baseline and Day 194). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02082184, which also lists 3 linked publications.
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 30 May 2017.