Trial Outcomes & Findings for Glucose Meter Study (NCT NCT00782496)

NCT ID: NCT00782496

Last Updated: 2016-02-29

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

211 participants

Primary outcome timeframe

6 months

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Level1 Basic Meter Features Adults with type 1 and type 2 diabetes using basic meter features	Level 2 Advanced Meter Features Adults with type 1 and type 2 diabetes using advanced meter features.
Overall Study STARTED	106	105
Overall Study COMPLETED	92	90
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Level1 Basic Meter Features Adults with type 1 and type 2 diabetes using basic meter features	Level 2 Advanced Meter Features Adults with type 1 and type 2 diabetes using advanced meter features.
Overall Study Lost to Follow-up	14	15

Baseline Characteristics

Glucose Meter Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Level1 Basic Meter Features n=106 Participants Adults with type 1 and type 2 diabetes using basic meter features	Level 2 Advanced Meter Features n=105 Participants Adults with type 1 and type 2 diabetes using advanced meter features.	Total n=211 Participants Total of all reporting groups
Age, Customized	53 years n=5 Participants	56 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	60 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	45 Participants n=7 Participants	98 Participants n=5 Participants
Region of Enrollment United States	106 participants n=5 Participants	105 participants n=7 Participants	211 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: For level 1, 14 subjects were lost to follow-up, that is they did not continue through the study's 4 visits, and data was not available. For level 2, 15 subjects were likewise lost to follow-up and data was not available. For units analyzed, 74 and 68 refer to the number of logbooks available.

Outcome measures

Outcome measures
Measure	Level1 Basic Meter Features n=74 Participants Adults with type 1 and type 2 diabetes using basic meter features	Level 2 Advanced Meter Features n=68 Participants Adults with type 1 and type 2 diabetes using advanced meter features.
Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features	7.1 number of post-prandial tests per week Standard Error 0.72	10.2 number of post-prandial tests per week Standard Error 0.72

SECONDARY outcome

Timeframe: Over six month period

Population: 63 surveys were available for analysis.

Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree.

Outcome measures

Outcome measures
Measure	Level1 Basic Meter Features n=63 Participants Adults with type 1 and type 2 diabetes using basic meter features	Level 2 Advanced Meter Features Adults with type 1 and type 2 diabetes using advanced meter features.
Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2	72.4 percent of Level 2 participants	—

Adverse Events

Level1 Basic Meter Features

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Level 2 Advanced Meter Features

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Carmine Greene, Senior Clinical Research Scientist

Ascensia Diabetes Care

Phone: 574-257-3040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Level1 Basic Meter Features n=94 participants at risk；n=106 participants at risk Adults with type 1 and type 2 diabetes using basic meter features	Level 2 Advanced Meter Features n=99 participants at risk；n=105 participants at risk Adults with type 1 and type 2 diabetes using advanced meter features.
Endocrine disorders Hypoglycemia	0.94% 1/106 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.	0.00% 0/105 • 6 months All serious adverse events were not linked to the study device.
Endocrine disorders Hyperglycemia	1.9% 2/106 • Number of events 2 • 6 months All serious adverse events were not linked to the study device.	0.00% 0/105 • 6 months All serious adverse events were not linked to the study device.
Cardiac disorders Heart attack	0.94% 1/106 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.	0.00% 0/105 • 6 months All serious adverse events were not linked to the study device.
Respiratory, thoracic and mediastinal disorders Trachial infection	0.00% 0/106 • 6 months All serious adverse events were not linked to the study device.	0.95% 1/105 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.
Endocrine disorders Adrenal growth	0.94% 1/106 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.	0.00% 0/105 • 6 months All serious adverse events were not linked to the study device.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.94% 1/106 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.	0.00% 0/105 • 6 months All serious adverse events were not linked to the study device.
Gastrointestinal disorders Diverticulosis	0.00% 0/106 • 6 months All serious adverse events were not linked to the study device.	0.95% 1/105 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.
Blood and lymphatic system disorders Sepsis	0.94% 1/106 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.	0.00% 0/105 • 6 months All serious adverse events were not linked to the study device.
Reproductive system and breast disorders Mastectomy	0.00% 0/106 • 6 months All serious adverse events were not linked to the study device.	0.95% 1/105 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.
Gastrointestinal disorders GI Bleeding	0.94% 1/106 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.	0.00% 0/105 • 6 months All serious adverse events were not linked to the study device.
Gastrointestinal disorders Upper abdominal pain	0.00% 0/106 • 6 months All serious adverse events were not linked to the study device.	0.95% 1/105 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.
Cardiac disorders Hypotensive	1.9% 2/106 • Number of events 3 • 6 months All serious adverse events were not linked to the study device.	0.00% 0/105 • 6 months All serious adverse events were not linked to the study device.
Blood and lymphatic system disorders Lower leg edema	0.94% 1/106 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.	0.00% 0/105 • 6 months All serious adverse events were not linked to the study device.
Cardiac disorders Coronary artery bypass	0.00% 0/106 • 6 months All serious adverse events were not linked to the study device.	0.95% 1/105 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.
Psychiatric disorders Eating disorder	0.94% 1/106 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.	0.00% 0/105 • 6 months All serious adverse events were not linked to the study device.
Blood and lymphatic system disorders Lymphadema of arm	0.00% 0/106 • 6 months All serious adverse events were not linked to the study device.	0.95% 1/105 • Number of events 1 • 6 months All serious adverse events were not linked to the study device.