Clinical trial NCT02082184: An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes
Official title: Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Sensing Technology
Type 2 Diabetes,
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2014-03-10
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c at 6 Months
timeFrame: Baseline and Day 194
Secondary outcomes:
measure: Time in Range
timeFrame: Baseline and Days 194 to 208
measure: Time Spent <70 mg/dL and <55 mg/dL
timeFrame: Baseline and Days 194 to 208
measure: Frequency of Episodes <70 mg/dL and <55 mg/dL
timeFrame: Baseline and Days 194 to 208
measure: Time Spent >180 mg/dL and >240 mg/dL
timeFrame: Baseline and Days 194 to 208
measure: Number of Glucose Measurements Performed
timeFrame: Days 15 to 208
measure: System Utilisation
timeFrame: Days 15 to 208
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.
timeFrame: Baseline and Day 194
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Haut Lévêque
city: Marseille
country: France
facility: Hôpital sainte Marguerite
city: Montpellier
country: France
facility: CHU Lapeyronie
city: Nancy
country: France
facility: CHU. Nancy
city: Nantes
country: France
facility: Hopital Guillaume et René Laennec
city: Paris
country: France
facility: Hospital Lariboisere
city: Paris
country: France
facility: Hôpital Cochin
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Bad Mergentheim
country: Germany
facility: Diabetes Zentrum Mergentheim
city: Eisenach
country: Germany
facility: Praris Dr Karin Schlecht
city: Hamburg
country: Germany
facility: Diabetologische Schwenpunlet Praxis
city: Hamburg
country: Germany
facility: Gemeiusilaftsproxis Fur Junere,
city: Hamburg
country: Germany
facility: Vorstandsmitglied Deutsche Diabetes-Hilfe
city: Münster
country: Germany
facility: Hohenzollernring
city: Quakenbrück
country: Germany
facility: Diabetes Center Quakenbruck
city: Rehburg-Loccum
country: Germany
facility: Diabetes Schwerpunktpraxis Loccum
city: Rosenheim
country: Germany
facility: An der Pforte
city: Sulzbach-Rosenberg
country: Germany
facility: Versdias GmbH
city: Ayr
country: United Kingdom
facility: Ayr Hospital
state: Ayrshire
city: Liverpool
country: United Kingdom
facility: Diabetes Research, Linda McCartney Centre, Royal Liverpool University Hospital
state: Cheshire
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Birmingham
country: United Kingdom
facility: FRCPath Life and Health Sciences, Aston University
city: Durham
country: United Kingdom
facility: University Hospital of North Durham
city: Ipswich
country: United Kingdom
facility: The Diabetes Centre, Ipswich Hospital NHS Trust
city: Leeds
country: United Kingdom
facility: St. James University Hospital, Leeds Teaching Hospitals NHS Trust
city: Rotherham
country: United Kingdom
facility: Rotherham General Hospital
Study officials:
affiliation: Research Institute of Diabetes Academy Mergentheim (FIDAM)
name: Thomas Haak
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.