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

NCT02082184 | Completed Results

• 1 other identifier: ADC-CI-APO-12018
• Study Type: interventional
• Target: 302
• Locations: 3 countries
• Sites: 26

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Sensing Technology; Type 2 Diabetes,

Outcome Measures

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.

  Baseline and Day 194

Secondary Outcomes (7)

• Time in Range

  Baseline and Days 194 to 208

• Time Spent <70 mg/dL and <55 mg/dL

  Baseline and Days 194 to 208

• Frequency of Episodes <70 mg/dL and <55 mg/dL

  Baseline and Days 194 to 208

• Time Spent >180 mg/dL and >240 mg/dL

  Baseline and Days 194 to 208

• Number of Glucose Measurements Performed

  Days 15 to 208

Study Arms (2)

Sensor Based Glucose Monitoring System

EXPERIMENTAL

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

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.

Device: Standard Blood Glucose Monitoring

Interventions

Sensor Based Glucose Monitoring System DEVICE

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.

Sensor Based Glucose Monitoring System

Standard Blood Glucose Monitoring DEVICE

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.

Standard Blood Glucose Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (26)

CHU Haut Lévêque

Bordeaux, 33604, France

Location

Hôpital sainte Marguerite

Marseille, 13274, France

Location

CHU Lapeyronie

Montpellier, 34295, France

Location

CHU. Nancy

Nancy, France

Location

Hopital Guillaume et René Laennec

Nantes, 44000, France

Location

Hospital Lariboisere

Paris, 75475, France

Location

Hôpital Cochin

Paris, 75679, France

Location

Hôpital Rangueil

Toulouse, 31059, France

Location

Diabetes Zentrum Mergentheim

Bad Mergentheim, 97980, Germany

Location

Praris Dr Karin Schlecht

Eisenach, 99817, Germany

Location

Diabetologische Schwenpunlet Praxis

Hamburg, 21073, Germany

Location

Gemeiusilaftsproxis Fur Junere,

Hamburg, 22607, Germany

Location

Vorstandsmitglied Deutsche Diabetes-Hilfe

Hamburg, Germany

Location

Hohenzollernring

Münster, 48145, Germany

Location

Diabetes Center Quakenbruck

Quakenbrück, 49610, Germany

Location

Diabetes Schwerpunktpraxis Loccum

Rehburg-Loccum, 31547, Germany

Location

An der Pforte

Rosenheim, 55545, Germany

Location

Versdias GmbH

Sulzbach-Rosenberg, Germany

Location

Ayr Hospital

Ayr, Ayrshire, KA6 6DX, United Kingdom

Location

Diabetes Research, Linda McCartney Centre, Royal Liverpool University Hospital

Liverpool, Cheshire, L7 8XP, United Kingdom

Location

Royal United Hospital

Bath, BA1 3NG, United Kingdom

Location

FRCPath Life and Health Sciences, Aston University

Birmingham, B4 7ET, United Kingdom

Location

University Hospital of North Durham

Durham, DH1 5TW, United Kingdom

Location

The Diabetes Centre, Ipswich Hospital NHS Trust

Ipswich, IP4 5PD, United Kingdom

Location

St. James University Hospital, Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Rotherham General Hospital

Rotherham, S60 2UD, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 28945936 DERIVED

• 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.

  PMID: 28401454 DERIVED

• 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.

  PMID: 28000140 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Snr Director, Clinical Development & Regulatory Affairs
• Organization: Abbott Diabetes Care

joe.bugler@abbott.com

01993 863164

Study Officials

• Thomas Haak

  Research Institute of Diabetes Academy Mergentheim (FIDAM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 30, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-04

Locations

FR (8); DE (10); GB (8)