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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Device: Sensor Based Glucose Monitoring System; Device: Standard Blood Glucose Monitoring

• Registration Number: NCT02082184
• Lead Sponsor: Abbott Diabetes Care

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-10
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Results First Submitted: 2017-03-03
• Results First Submitted QC: 2017-03-03
• Status Verified: 2017-04
• Results First Posted: 2017-04-14
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sensor Based Glucose Monitoring System	Sensor Based Glucose Monitoring System	Standard system use for 6 months. Followed by open access to the device for 6 months.
Standard Blood Glucose Monitoring	Standard Blood Glucose Monitoring	Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Primary Outcome Measures

Name	Time	Method
HbA1c at 6 Months	Baseline and Day 194	Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.

Secondary Outcome Measures

Name	Time	Method
Number of Glucose Measurements Performed	Days 15 to 208	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.
System Utilisation	Days 15 to 208	Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.	Baseline and 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 in Range	Baseline and Days 194 to 208	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 Spent <70 mg/dL and <55 mg/dL	Baseline and Days 194 to 208	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.
Frequency of Episodes <70 mg/dL and <55 mg/dL	Baseline and Days 194 to 208	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 Spent >180 mg/dL and >240 mg/dL	Baseline and Days 194 to 208	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.

Trial Locations

Locations (26)

CHU Lapeyronie; 🇫🇷 Montpellier, France

Diabetes Zentrum Mergentheim; 🇩🇪 Bad Mergentheim, Germany

Hospital Lariboisere; 🇫🇷 Paris, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital sainte Marguerite; 🇫🇷 Marseille, France

CHU. Nancy; 🇫🇷 Nancy, France

CHU Haut Lévêque; 🇫🇷 Bordeaux, France

Hopital Guillaume et René Laennec; 🇫🇷 Nantes, France

Hôpital Rangueil; 🇫🇷 Toulouse, France

Praris Dr Karin Schlecht; 🇩🇪 Eisenach, Germany

Diabetologische Schwenpunlet Praxis; 🇩🇪 Hamburg, Germany

Royal United Hospital; 🇬🇧 Bath, United Kingdom

Hohenzollernring; 🇩🇪 Münster, Germany

Ayr Hospital; 🇬🇧 Ayr, Ayrshire, United Kingdom

Diabetes Research, Linda McCartney Centre, Royal Liverpool University Hospital; 🇬🇧 Liverpool, Cheshire, 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

Versdias GmbH; 🇩🇪 Sulzbach-Rosenberg, Germany

FRCPath Life and Health Sciences, Aston University; 🇬🇧 Birmingham, United Kingdom

Rotherham General Hospital; 🇬🇧 Rotherham, United Kingdom

Gemeiusilaftsproxis Fur Junere,; 🇩🇪 Hamburg, Germany

Vorstandsmitglied Deutsche Diabetes-Hilfe; 🇩🇪 Hamburg, Germany

Diabetes Center Quakenbruck; 🇩🇪 Quakenbrück, Germany

Diabetes Schwerpunktpraxis Loccum; 🇩🇪 Rehburg-Loccum, Germany

An der Pforte; 🇩🇪 Rosenheim, Germany