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CompletedNCT02082184REPLACEUpdated May 30, 2017Results posted

An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes

An interventional study of Sensor Based Glucose Monitoring System and Standard Blood Glucose Monitoring in Type 2 Diabetes Mellitus, sponsored by Abbott Diabetes Care. Completed at 26 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by Abbott Diabetes Care · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
302
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Sensing Technology
  • Type 2 Diabetes,
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 302 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Abbott Diabetes Care is the lead sponsor of 42 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Has Type 2 diabetes on insulin therapy for ≥ 6 months and on their current regimen for ≥3 months prior to study entry.

  2. Their insulin management must be one of the following;

    1. an injection regimen of prandial insulin at least once daily,
    2. or, prandial insulin at least once daily plus basal insulin at least once daily,
    3. or, continuous subcutaneous insulin infusion (CSII) with no plans to change during the study.
  3. HbA1c result ≥7.5% (58 mmol/mol) and ≤12.0% (108 mmol/mol) on entry to the study.
  4. 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.
  5. In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System.
  6. In the Investigator's opinion the subject is proactive and therefore willing to modify their diabetes management
  7. Aged 18 years or over.

Exclusion criteria

Exclusion Criteria:

  1. Insulin regimen consists entirely of basal or includes bi-phasic insulin.
  2. Subject is currently prescribed animal insulin.
  3. Subject is currently prescribed steroid therapy or is likely to require steroid therapy for any acute or chronic condition during the study.
  4. Has known allergy to medical grade adhesives.
  5. Currently participating in another device or drug study that could affect glucose measurements or glucose management.
  6. Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months.
  7. Is planning to use a CGM device at any time during the study.
  8. Total daily dose of insulin (TDD) is >1.75iu/kg at entry to the study.
  9. A female subject who is pregnant or planning to become pregnant within the study duration.
  10. Currently receiving dialysis treatment or planning to receive dialysis during the study.
  11. Has experienced an acute myocardial infarction within previous 6 months.
  12. 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.
  13. Has a pacemaker or any other neuro stimulators.
  14. Has experienced any episode of severe hypoglycaemia, requiring third party assistance and/or admission to hospital, in the previous 6 months.
  15. Has experienced any episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) in the previous 6 months.
  16. In the investigator's opinion, the subject is considered as unsuitable for inclusion in the study for any other reason.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
302 participants (actual)

Study arms

  • Experimental
    Sensor Based Glucose Monitoring System

    Standard system use for 6 months. Followed by open access to the device for 6 months.

    Device: Sensor Based Glucose Monitoring System

  • Active comparator
    Standard Blood Glucose Monitoring

    Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

    Device: Standard Blood Glucose Monitoring

Interventions

  • DeviceSensor Based Glucose Monitoring System

    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.

  • DeviceStandard Blood Glucose Monitoring

    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.

06

What researchers measure

Primary outcomes

  1. HbA1c at 6 Months

    Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.

    Time frame: Baseline and Day 194

Secondary outcomes

  1. 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.

    Time frame: Baseline and Days 194 to 208

  2. 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.

    Time frame: Baseline and Days 194 to 208

  3. 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.

    Time frame: Baseline and Days 194 to 208

  4. 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.

    Time frame: Baseline and Days 194 to 208

  5. 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.

    Time frame: Days 15 to 208

  6. System Utilisation

    Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.

    Time frame: Days 15 to 208

  7. 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).

    Time frame: Baseline and Day 194

07

Results

Posted Apr 14, 2017

Participant flow

Participant flow — Overall Study
MilestoneSensor Based Glucose Monitoring SystemStandard Blood Glucose Monitoring
Started14975
Completed13962
Not completed1013
Withdrew: Adverse event10
Withdrew: Medical diagnosis12
Withdrew: Device associated symptoms50
Withdrew: Withdrawal by subject32
Withdrew: Protocol violation06
Withdrew: Lost to follow-up02
Withdrew: Subject non-compliance01

Outcome measures

PrimaryHbA1c at 6 Months

Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.

Time frame:
Baseline and Day 194
Reported as:
Mean · percentage of Glycated Haemoglobin
HbA1c at 6 Months
percentage of Glycated HaemoglobinSensor Based Glucose Monitoring SystemStandard Blood Glucose Monitoring
Baseline8.65 ± 1.018.75 ± 0.98
Day 1948.37 ± 0.838.34 ± 1.14
Statistical analysis
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = 0.8222 · Mean difference (final values): 0.03
SecondaryTime 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.

Time frame:
Baseline and Days 194 to 208
Reported as:
Mean · hours per day
Time in Range
hours per daySensor Based Glucose Monitoring SystemStandard Blood Glucose Monitoring
Baseline13.9 ± 4.513.5 ± 5.2
Days 194-20813.6 ± 4.613.2 ± 4.9
Statistical analysis
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = 0.7925 · Mean difference (final values): 0.2
SecondaryTime 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.

Time frame:
Baseline and Days 194 to 208
Reported as:
Mean · hours per day
Time Spent <70 mg/dL and <55 mg/dL
hours per daySensor Based Glucose Monitoring SystemStandard Blood Glucose Monitoring
Time spent <70 mg/dL, Baseline1.30 ± 1.781.08 ± 1.58
Time spent <70 mg/dL, Days 194-2080.59 ± 0.820.99 ± 1.29
Time spent <55 mg/dL, Baseline0.59 ± 1.130.38 ± 0.83
Time spent <55 mg/dL, Days 194-2080.19 ± 0.370.37 ± 0.69
Statistical analysis
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = <0.001 · Mean difference (final values): -0.47
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = 0.0014 · Mean difference (final values): -0.22
SecondaryFrequency 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.

Time frame:
Baseline and Days 194 to 208
Reported as:
Mean · number of episodes per day
Frequency of Episodes <70 mg/dL and <55 mg/dL
number of episodes per daySensor Based Glucose Monitoring SystemStandard Blood Glucose Monitoring
Frequency of episodes <70 mg/dL, Baseline0.64 ± 0.630.63 ± 0.66
Frequency of episodes <70 mg/dL, Days 194-2080.38 ± 0.450.53 ± 0.59
Frequency of episodes <55 mg/dL, Baseline0.34 ± 0.500.27 ± 0.44
Frequency of episodes <55 mg/dL, Days 194-2080.14 ± 0.240.24 ± 0.36
Statistical analysis
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = 0.0164 · Mean difference (final values): -0.16
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = 0.0017 · Mean difference (final values): -0.12
SecondaryTime 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.

Time frame:
Baseline and Days 194 to 208
Reported as:
Mean · hours per day
Time Spent >180 mg/dL and >240 mg/dL
hours per daySensor Based Glucose Monitoring SystemStandard Blood Glucose Monitoring
Time spent >180 mg/dL, Baseline8.8 ± 5.09.4 ± 5.8
Time spent >180 mg/dL, Days 194-2089.8 ± 4.89.8 ± 5.4
Time spent >240 mg/dL, Baseline3.1 ± 3.33.9 ± 4.5
Time spent >240 mg/dL, Days 194-2083.5 ± 3.73.9 ± 4.2
Statistical analysis
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = 0.5970 · Mean difference (final values): 0.3
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = 0.8729 · Mean difference (final values): 0.1
SecondaryNumber 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.

Time frame:
Days 15 to 208
Reported as:
Mean · number of measurements per day
Number of Glucose Measurements Performed
number of measurements per daySensor Based Glucose Monitoring SystemStandard Blood Glucose Monitoring
Number of fingerstick tests, Days 194-2080.4 ± 1.03.8 ± 1.9
Number of sensor scans, Days 15-2088.3 ± 4.4NA ± NA
SecondarySystem Utilisation

Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.

Time frame:
Days 15 to 208
Reported as:
Mean · percentage of sensor glucose collected
System Utilisation
percentage of sensor glucose collectedSensor Based Glucose Monitoring System
System Utilisation88.7 ± 9.2
SecondaryChange 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).

Time frame:
Baseline and Day 194
Reported as:
Mean · units on a scale
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.
units on a scaleSensor Based Glucose Monitoring SystemStandard Blood Glucose Monitoring
Hyperglycaemia0.3 ± 1.90.2 ± 1.7
Hypoglycaemia-0.2 ± 1.60.0 ± 1.4
Treatment Satisfaction13.4 ± 4.39.6 ± 5.6
Statistical analysis
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = 0.6075 · Mean difference (final values): -0.2
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = 0.2295 · Mean difference (final values): -0.3
  • Sensor Based Glucose Monitoring System vs Standard Blood Glucose Monitoring · ANCOVA · p = <0.001 · Mean difference (final values): 4.1

Adverse events

Collected over Adverse events collected from enrolment (6 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sensor Based Glucose Monitoring System—16/149 (10.7%)49/149 (32.9%)
Standard Blood Glucose Monitoring—12/75 (16%)27/75 (36%)
Most frequent serious events
Showing 10 of 37
Most frequent serious events
EventSensor Based Glucose Monitoring SystemStandard Blood Glucose Monitoring
cerebrovascular accidentNervous system disorders0/1492/75
gastrointestinal carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/1490/75
hypoglycaemiaMetabolism and nutrition disorders2/1491/75
acute coronary syndromeCardiac disorders0/1491/75
angina pectorisCardiac disorders0/1491/75
atrial fibrillationCardiac disorders0/1491/75
cerebellar ischemiaNervous system disorders0/1491/75
cholecystitisHepatobiliary disorders0/1491/75
confusional statePsychiatric disorders0/1491/75
enteritisGastrointestinal disorders0/1491/75
Most frequent other events
Most frequent other events
EventSensor Based Glucose Monitoring SystemStandard Blood Glucose Monitoring
NasopharyngitisInfections and infestations30/14910/75
HypoglycaemiaMetabolism and nutrition disorders10/1497/75
Back painMusculoskeletal and connective tissue disorders11/1496/75
DiarrhoeaGastrointestinal disorders7/1496/75
Low density lipoprotein increasedInvestigations3/1494/75
Blood cholesterol increasedInvestigations1/1494/75

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sensor Based Glucose Monitoring SystemStandard Blood Glucose MonitoringTotal
Mean59.0 ± 9.959.5 ± 11.059.2 ± 10.3
Sex: Female, Male
Sex: Female, Male(Participants)Sensor Based Glucose Monitoring SystemStandard Blood Glucose MonitoringTotal
Female551974
Male9456150
Screening HbA1c
Screening HbA1c(%)Sensor Based Glucose Monitoring SystemStandard Blood Glucose MonitoringTotal
Mean8.74 ± 0.978.88 ± 1.048.79 ± 0.99
Screening HbA1c
Screening HbA1c(mmol/mol)Sensor Based Glucose Monitoring SystemStandard Blood Glucose MonitoringTotal
Mean72.0 ± 10.673.5 ± 11.372.5 ± 10.8
08

Study locations

26 sites
  • CHU Haut Lévêque
    Bordeaux, 33604, France
  • Hôpital sainte Marguerite
    Marseille, 13274, France
  • CHU Lapeyronie
    Montpellier, 34295, France
  • CHU. Nancy
    Nancy, France
  • Hopital Guillaume et René Laennec
    Nantes, 44000, France
  • Hospital Lariboisere
    Paris, 75475, France
  • Hôpital Cochin
    Paris, 75679, France
  • Hôpital Rangueil
    Toulouse, 31059, France
  • Diabetes Zentrum Mergentheim
    Bad Mergentheim, 97980, Germany
  • Praris Dr Karin Schlecht
    Eisenach, 99817, Germany
  • Diabetologische Schwenpunlet Praxis
    Hamburg, 21073, Germany
  • Gemeiusilaftsproxis Fur Junere,
    Hamburg, 22607, Germany
  • Vorstandsmitglied Deutsche Diabetes-Hilfe
    Hamburg, Germany
  • Hohenzollernring
    Münster, 48145, Germany
  • Diabetes Center Quakenbruck
    Quakenbrück, 49610, Germany
  • Diabetes Schwerpunktpraxis Loccum
    Rehburg-Loccum, 31547, Germany
  • An der Pforte
    Rosenheim, 55545, Germany
  • Versdias GmbH
    Sulzbach-Rosenberg, Germany
  • Ayr Hospital
    Ayr, Ayrshire KA6 6DX, United Kingdom
  • Diabetes Research, Linda McCartney Centre, Royal Liverpool University Hospital
    Liverpool, Cheshire L7 8XP, United Kingdom
  • Royal United Hospital
    Bath, BA1 3NG, United Kingdom
  • FRCPath Life and Health Sciences, Aston University
    Birmingham, B4 7ET, United Kingdom
  • University Hospital of North Durham
    Durham, DH1 5TW, United Kingdom
  • The Diabetes Centre, Ipswich Hospital NHS Trust
    Ipswich, IP4 5PD, United Kingdom
  • St. James University Hospital, Leeds Teaching Hospitals NHS Trust
    Leeds, LS9 7TF, United Kingdom
  • Rotherham General Hospital
    Rotherham, S60 2UD, United Kingdom
09

References and documents

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 28945936 ↗
  • Haak 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 28401454 ↗
  • Haak 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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02082184
Lead sponsor
Abbott Diabetes Care
Responsible party
Sponsor
First posted
Mar 10, 2014
Start date
Mar 2014
Primary completion
Jun 2015
Completion
Dec 2015
Results posted
Apr 14, 2017
Last update
May 30, 2017

Study contacts

Thomas Haak
principal investigator · Research Institute of Diabetes Academy Mergentheim (FIDAM)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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