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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensor Based Glucose Monitoring System | Experimental | Standard system use for 6 months. Followed by open access to the device for 6 months. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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;
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Haak | Research Institute of Diabetes Academy Mergentheim (FIDAM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Haut Lévêque | Bordeaux | 33604 | France | |||
| Hôpital sainte Marguerite |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28945936 | Derived | 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. | |
| 28401454 | 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. |
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A total of 302 subjects consented and enrolled into the study. Seventy-eight (78) of these failed screening or withdrew before randomisation. Two hundred and twenty-four (224) subjects were randomised and 201 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensor Based Glucose Monitoring System | Standard system use for 6 months. Followed by open access to the device for 6 months. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
|
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 |
| Marseille |
| 13274 |
| France |
| CHU Lapeyronie | Montpellier | 34295 | France |
| CHU. Nancy | Nancy | France |
| Hopital Guillaume et René Laennec | Nantes | 44000 | France |
| Hospital Lariboisere | Paris | 75475 | France |
| Hôpital Cochin | Paris | 75679 | France |
| Hôpital Rangueil | Toulouse | 31059 | France |
| Diabetes Zentrum Mergentheim | Bad Mergentheim | 97980 | Germany |
| Praris Dr Karin Schlecht | Eisenach | 99817 | Germany |
| Diabetologische Schwenpunlet Praxis | Hamburg | 21073 | Germany |
| Gemeiusilaftsproxis Fur Junere, | Hamburg | 22607 | Germany |
| Vorstandsmitglied Deutsche Diabetes-Hilfe | Hamburg | Germany |
| Hohenzollernring | Münster | 48145 | Germany |
| Diabetes Center Quakenbruck | Quakenbrück | 49610 | Germany |
| Diabetes Schwerpunktpraxis Loccum | Rehburg-Loccum | 31547 | Germany |
| An der Pforte | Rosenheim | 55545 | Germany |
| Versdias GmbH | Sulzbach-Rosenberg | Germany |
| Ayr Hospital | Ayr | Ayrshire | KA6 6DX | United Kingdom |
| Diabetes Research, Linda McCartney Centre, Royal Liverpool University Hospital | Liverpool | Cheshire | L7 8XP | United Kingdom |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| FRCPath Life and Health Sciences, Aston University | Birmingham | B4 7ET | United Kingdom |
| University Hospital of North Durham | Durham | DH1 5TW | United Kingdom |
| The Diabetes Centre, Ipswich Hospital NHS Trust | Ipswich | IP4 5PD | United Kingdom |
| St. James University Hospital, Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| Rotherham General Hospital | Rotherham | S60 2UD | United Kingdom |
| 28000140 | 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. |
| FG001 | Standard Blood Glucose Monitoring | Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration. 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensor Based Glucose Monitoring System | Standard system use for 6 months. Followed by open access to the device for 6 months. 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. |
| BG001 | Standard Blood Glucose Monitoring | Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Screening HbA1c | Mean | Standard Deviation | % |
| |||||||||||||||
| Screening HbA1c | Mean | Standard Deviation | mmol/mol |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c at 6 Months | Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA. | Posted | Mean | Standard Deviation | percentage of Glycated Haemoglobin | Baseline and Day 194 |
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| 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) using ANCOVA. | Posted | Mean | Standard Deviation | hours per day | Baseline and Days 194 to 208 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | hours per day | Baseline and Days 194 to 208 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | number of episodes per day | Baseline and Days 194 to 208 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | hours per day | Baseline and Days 194 to 208 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | number of measurements per day | Days 15 to 208 |
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| Secondary | System Utilisation | Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group. | 138 subjects included in the analysis, 11 were not included due to missing data. | Posted | Mean | Standard Deviation | percentage of sensor glucose collected | Days 15 to 208 |
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| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 194 |
|
Adverse events collected from enrolment (6 months)
In addition to the serious adverse events listed below, 1 subject who withdrew from the study before randomisation reported serious adverse events of hypoglycaemia and renal impairment.
No serious adverse events were related to the study device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sensor Based Glucose Monitoring System | Standard system use for 6 months. Followed by open access to the device for 6 months. 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. | 16 | 149 | 49 | 149 | ||
| EG001 | Standard Blood Glucose Monitoring | Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration. 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. | 12 | 75 | 27 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute coronary syndrome | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
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| angina pectoris | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
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| atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
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| muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
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| arrhythmia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
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| cerebellar ischemia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| chest pain | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| cholecystitis | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
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| confusional state | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| congestive cardiomyopathy | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
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| enteritis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| forearm fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
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| gastric ulcer | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| gastroenteritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| gastrointestinal infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| haematemesis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
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| hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
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| hypoglycaemic coma | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| intercostal neuralgia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| renal failure | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
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| labyrinthitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| myositis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| acute myocardial infarction | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
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| oesophagael carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
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| pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
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| pancreatic neuroendocrine tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
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| cellulitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| retinal detachment | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
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| transient ischaemic attack | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| death | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Low density lipoprotein increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Snr Director, Clinical Development & Regulatory Affairs | Abbott Diabetes Care | 01993 863164 | joe.bugler@abbott.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Standard Blood Glucose Monitoring |
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration. 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. |
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