Trial Outcomes & Findings for Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes (NCT NCT01341067)

NCT ID: NCT01341067

Last Updated: 2014-05-02

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: Measured at 6 months
• Results posted on: 2014-05-02

Participant Flow

Participant milestones

Measure	Basal Insulin, Approved Oral Medications Basal insulin, with or without approved oral agents
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Basal Insulin, Approved Oral Medications n=30 Participants Basal insulin, with or without approved oral agents
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at 6 months

Outcome measures

Measure	Basal Insulin, Approved Oral Medications n=26 Participants Basal insulin, with or without approved oral agents
Change in HgbA1c	-1.9 percentage of glycosylated hemoglobin Standard Deviation 1.1 • Interval -3.0 to -0.8

SECONDARY outcome

Timeframe: Measured at baseline and at 6 months

Outcome measures

Measure	Basal Insulin, Approved Oral Medications n=26 Participants Basal insulin, with or without approved oral agents
Percentage of Time Spent at Glycemic Levels <65 mg/dl	.04 percentage of time spent < 65 mg/dl Standard Deviation 1.0 • Interval -0.6 to 1.4

SECONDARY outcome

Timeframe: Measured at baseline and 6 months

Outcome measures

Measure	Basal Insulin, Approved Oral Medications n=26 Participants Basal insulin, with or without approved oral agents
Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl	-8.5 percentage of time spent >180 mg/dl Standard Deviation 16.9

SECONDARY outcome

Timeframe: Assessed at baseline and 6 months

Outcome measures

Measure	Basal Insulin, Approved Oral Medications n=26 Participants Basal insulin, with or without approved oral agents
Change in Basal Insulin Dose From Baseline Values	0.3 units of insulin Standard Deviation 16.7

Adverse Events

Basal Insulin, Approved Oral Medications

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Basal Insulin, Approved Oral Medications n=30 participants at risk Basal insulin, with or without approved oral agents
Skin and subcutaneous tissue disorders Insertion site irritation	10.0% 3/30 • Number of events 3 0 serious adverse events were recorded. 3 device related adverse events were recorded.

Additional Information

Mark Sulik, PharmD CCRP

Rocky Mountain Diabetes and Osteoporosis Center

Phone: 208-528-9642

Email: mark@idahomed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place