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

Type 2 Diabetes Mellitus Clinical Trial

— REPLACE  

Official title:

Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082184
• Other study ID #: ADC-CI-APO-12018
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: January 19, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Conseil National de l'Ordre des MédecinsFrance: Institutional Ethical CommitteeFrance: National Consultative Ethics Committee for Health and Life SciencesGermany: Ethics CommissionGermany: German Institute of Medical Documentation and InformationUnited Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU Haut Lévêque	Bordeaux
France	Hôpital sainte Marguerite	Marseille
France	CHU Lapeyronie	Montpellier
France	CHU. Nancy	Nancy
France	Hopital Guillaume et René Laennec	Nantes
France	Hôpital Cochin	Paris
France	Hospital Lariboisere	Paris
France	Hôpital Rangueil	Toulouse
Germany	Diabetes Zentrum Mergentheim	Bad Mergentheim
Germany	Praris Dr Karin Schlecht	Eisenach
Germany	Diabetologische Schwenpunlet Praxis	Hamburg
Germany	Gemeiusilaftsproxis Fur Junere,	Hamburg
Germany	Vorstandsmitglied Deutsche Diabetes-Hilfe	Hamburg
Germany	Hohenzollernring	Münster
Germany	Diabetes Center Quakenbruck	Quakenbrück
Germany	Diabetes Schwerpunktpraxis Loccum	Rehburg-Loccum
Germany	An der Pforte	Rosenheim
Germany	Versdias GmbH	Sulzbach-Rosenberg
United Kingdom	Ayr Hospital	Ayr	Ayrshire
United Kingdom	Royal United Hospital	Bath
United Kingdom	FRCPath Life and Health Sciences, Aston University	Birmingham
United Kingdom	University Hospital of North Durham	Durham
United Kingdom	The Diabetes Centre, Ipswich Hospital NHS Trust	Ipswich
United Kingdom	St. James University Hospital, Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Diabetes Research, Linda McCartney Centre, Royal Liverpool University Hospital	Liverpool	Cheshire
United Kingdom	Rotherham General Hospital	Rotherham

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Countries where clinical trial is conducted

France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c at 6 months	Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1	Baseline and 194 days	No
Secondary	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).	Baseline and Days 194 to 208	No
Secondary	Change in Time in Range at Day 45	Change is defined as time in range 70 - 180 mg/dL in days 31 -45 minus time in range at baseline (days 1- 15) in the intervention group	Baseline and Days 31 to 45	No
Secondary	Decrease in HbA1c by greater than or equal to 0.5%	Difference in the proportion of subjects with a greater than or equal to 0.5% reduction in HbA1c from baseline at day 194 between intervention and control group	Baseline and Day 194	No
Secondary	6 Month HbA1c Level =7.5%	Difference in the proportion of subjects that achieve HbA1c level =7.5% at day 194 between intervention and control group	Day 194	No
Secondary	HbA1c at 3 Months	Difference in HbA1c between intervention and control group at day 105 adjusting for baseline HbA1c at day 1	Baseline and 105 Days	No
Secondary	Mean Glucose	Difference in mean glucose between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). mean glucose	Baseline and Days 194 to 208	No
Secondary	Glucose variability	Difference in continuous overall net glycaemic action (CONGA) (1, 2 & 4 hour), standard deviation (SD) rate of change, (mean amplitude of glycaemic excursions) MAGE, mean of daily differences (MODD) , hign blood glucose index (HBGI) , low blood glucose index (LBGI) post prandial glucose peak, time to peak, excursion and area under the curve (AUC) >180mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). Post prandial glucose peak, time to peak, excursion and AUC>180mg/dL will be calculated during the 3 hours after each logged meal, for each subject and timeframe. Glucose excursion is change from meal time to peak glucose.	Baseline and Days 194 to 208	No
Secondary	Time spent and frequency < 70 mg/dL and <55mg/dL	Difference in time and frequency < 70 mg/dL and <55mg/dL(hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).	Baseline and Days 194 to 208	No
Secondary	Time spent and frequency > 180 mg/dL and > 240mg/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).	Baseline and Days 194 to 208	No
Secondary	Number of episodes of diabetic ketoacidosis (DKA), Hyperosmolar hyperglycaemic state (HHS), and severe hypoglycaemia.	The number of episodes of DKA, HHS and severe hypoglycaemia.will be summarised in the intervention and control group in each timeframe.	Baseline and Days 15 to 208	Yes
Secondary	Total daily dose of insulin (TDD)	Difference in TDD between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) TDD. TDD calculated from Reader uploads.	Baseline and Days 194 to 208	No
Secondary	Body weight, BMI, blood pressure and lipids at 6 Months	Difference in body weight, BMI blood pressure and lipids between intervention and control group assessed at day 194 adjusting for baseline (day 1).	Baseline (day 1) and Day 194	No
Secondary	User Questionnaire (Subject & HCP) at 6 Months	User questionnaire responses will be tabulated as number and percentage of subjects with each response. HCP questionnaire responses will be tabulated as number and percentage of HCPs with each response	Day 208	No
Secondary	Quality of Life	Includes diabetes treatment satisfaction questionnaire (DTSQ), diabetes distress scale(DDS) & diabetes quality of life (DQoL) Difference in each score between intervention and control group assessed at day 194 adjusting for the corresponding score at baseline (day 1).	Baseline and Day 194	No
Secondary	Clinic time and medication usage	The number of emergency room visits, admissions, additional non protocol related clinic time and medication usage will be summarised in the intervention and control group in each timeframe (days 1-15 and days 15 -208).	Baseline (days 1 -15) and Days 15 to 208	No
Secondary	Number of glucose measurements performed	Difference in frequency (number per day) of blood glucose finger stick tests between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) frequency of finger stick tests performed. The frequency of sensor scans performed will be summarised in the intervention group in days 194 to 208.	Baseline and Days 194 to 208	No
Secondary	Adverse Events	The number of adverse events in days -30 to 208 will be tabulated as the number and percentage of subjects experiencing adverse events in the intervention and control groups, classified by seriousness, severity, relationship to the device and relationship to the study. Glycaemic adverse events will be classed separately.	Days -30 to 208	Yes
Secondary	Adverse Events Open Access Phase	The number of adverse events in days 208 to 388 will be tabulated as the number and percentage of subjects experiencing adverse events in the intervention and control groups, classified by seriousness, severity, relationship to the device and relationship to the study. Glycaemic adverse events will be classed separately.	Days 208 to 388	Yes
Secondary	Adverse Events at 1 Month	The number of adverse events in days -30 to 45 will be tabulated as the number and percentage of subjects experiencing adverse events in the intervention groups, classified by seriousness, severity, relationship to the device and relation to the study, Glycaemic adverse events will be classed separately.	Days -30 to 45	Yes