An Evaluation of Novel Glucose Sensing Technology on Hypo... | NCT02232698

NCT02232698

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sensor Based Glucose Monitoring System	Experimental	Standard sensing system use 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

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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time Spent <70 mg/dL	Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).	Baseline and Days 194 to 208

Secondary Outcomes

Measure	Description	Time Frame
HbA1c at 6 Months	Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1	Baseline and Day 208
Time Spent <55 mg/dL and <40 mg/dL	Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with Type 1 diabetes for ≥ 5 years
On their current insulin regimen for ≥ 3 months prior to study entry
Screening HbA1c result ≤ 7.5% (58 mmol/mol)
Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily 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
Aged 18 years or over.

Exclusion Criteria:

Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia)
Subject is currently prescribed animal insulin
Subject is currently prescribed oral steroid therapy or is likely to require oral 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
Currently using Sensor augmented pump therapy
Is planning to use a CGM device at any time during the study
A female subject who is pregnant or planning to become pregnant within the study duration
A breast feeding mother
Currently receiving dialysis treatment or planning to receive dialysis during the study
Has a pacemaker
Has experienced an acute myocardial infarction within previous 6 months
Has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition
Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.

Contacts/Locations Module

Name	Affiliation	Role
Stephan Matthaei	Diabetes Center Quakenbruck	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie		Feldkirch		6807	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29273897	Derived	Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018 Mar;61(3):539-550. doi: 10.1007/s00125-017-4527-5. Epub 2017 Dec 23.
28945936

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

2 pregnant subjects (1 in each group) were excluded from all efficacy analysis (as stated in the protocol).

Arm/Group Information

ID	Title	Description
BG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00042.4± 13.1 BG00145.0± 14.6 BG00243.7± 13.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00042 BG00161 BG002

Screening HbA1c

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG0006.73± 0.52 BG0016.74± 0.59 BG002

Screening HbA1c

Mean

Standard Deviation

mmol/mol

Title

Denominators

Categories

Title	Measurements
	BG00050.1± 5.7 BG00150.2± 6.5 BG002

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

Time Spent <70 mg/dL

Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).

1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.

Posted

Mean

Standard Deviation

hours per day

Baseline and Days 194 to 208

ID	Title	Description
OG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
OG001	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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Units	Counts
Participants	OG000119 OG001119

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0003.38± 2.31 OG0013.44± 2.62

Days 194-208

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<0.0001		Mean Difference (Final Values)	-1.24	Standard Error of the Mean	0.239	2-Sided								Superiority or Other

Secondary

HbA1c at 6 Months

Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1

Posted

Mean

Standard Deviation

percentage of Glycated Haemoglobin

Baseline and Day 208

ID	Title	Description
OG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
OG001	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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Secondary

Time Spent <55 mg/dL and <40 mg/dL

Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).

1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.

Posted

Mean

Standard Deviation

hours per day

Baseline and Days 194 to 208

ID	Title	Description
OG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
OG001	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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Secondary

Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL

Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).

1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.

Posted

Mean

Standard Deviation

number of episodes per day

Baseline and Days 194-208

ID	Title	Description
OG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
OG001	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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Secondary

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

Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).

1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.

Posted

Mean

Standard Deviation

hours per day

Baseline and Days 194 to 208

ID	Title	Description
OG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
OG001	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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

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).

1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.

Posted

Mean

Standard Deviation

hours per day

Baseline and Days 194 to 208

ID	Title	Description
OG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
OG001	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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Secondary

Number of Glucose Measurements Performed

Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.

Posted

Mean

Standard Deviation

number of measurements per day

Days 1 to 208

ID	Title	Description
OG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
OG001	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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Secondary

System Utilisation

System utilisation assessed by percentage of sensor glucose data collected by the intervention group

112 subjects included in the analysis, 7 were not included due to missing data.

Posted

Mean

Standard Deviation

percentage of sensor glucose collected

Days 15 to 208

ID	Title	Description
OG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Units	Counts
Participants	OG000

Secondary

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208

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 208

ID	Title	Description
OG000	Sensor Based Glucose Monitoring System	Standard sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
OG001	Standard Blood Glucose Monitoring

Arm/Groups

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 sensing system use 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. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).			4	120	33	120
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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).			4	121	24	121

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
atrial fibrillation	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected121 at risk
retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected121 at risk
hyperglycaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected121 at risk
hypoglycaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected120 at risk EG0014 events3 affected121 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
medical device site reaction	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00013 events10 affected120 at risk EG0010 events0 affected121 at risk
influenza	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0007 events7 affected120 at risk EG0017 events7 affected121 at risk
nasopharyngitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG00020 events19 affected120 at risk EG00119 events17 affected121 at risk

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

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 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).

All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).