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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: Sensor Based Glucose Monitoring System; Device: Standard Blood Glucose Monitoring

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c at 6 Months	Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.	Baseline and Day 194

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Days 15 to 208
System Utilisation	Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.	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).	Baseline and Day 194

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Investigators: Principal Investigator: Thomas Haak, Research Institute of Diabetes Academy Mergentheim (FIDAM)

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 6, 2014
• First Submitted That Met QC Criteria: March 7, 2014
• First Posted (Estimate): March 10, 2014

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Sensing Technology; Type 2 Diabetes,
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ADC-CI-APO-12018