Trial Outcomes & Findings for Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (NCT NCT01237301)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

124 participants

Primary outcome timeframe

2 week baseline to 16 week final

Results posted on

2018-10-17

Participant Flow

Recruitment Period October 29, 2010 through November 25, 2011. Study Location: Clinic

Participant milestones

Participant milestones
Measure	CGM Group Wear an unblinded CGM for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.	SMBG Group Use SMBG 4 to 7 times a day for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.
Overall Study STARTED	65	59
Overall Study COMPLETED	60	55
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CGM Group n=65 Participants Wear an unblinded CGM for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.	SMBG Group n=59 Participants Use SMBG 4 to 7 times a day for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.	Total n=124 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	12 Participants n=7 Participants	31 Participants n=5 Participants
Age, Continuous	59.3 years STANDARD_DEVIATION 8.9 • n=5 Participants	58.8 years STANDARD_DEVIATION 10 • n=7 Participants	59 years STANDARD_DEVIATION 0.9 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	27 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants	59 participants n=7 Participants	124 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 week baseline to 16 week final

Population: Per Protocol

Outcome measures

Outcome measures
Measure	CGM Group n=65 Participants Wear an unblinded CGM for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.	SMBG Group n=59 Participants Use SMBG 4 to 7 times a day for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.
Percentage Change in Hemoglobin A1c	-1.12 percentage of HbA1c Standard Deviation 1.07	-0.82 percentage of HbA1c Standard Deviation 0.91

SECONDARY outcome

Timeframe: 16 weeks

The secondary objective is to determine the incremental benefit of CGM for clinical decision-making by using (area under the diurnal median curve). Data was collected to create the curve at every hour of modal day. Example: hours 1-24 of each day. Modal day reflects 14 days worth of CGM data aggregated into a single 24 hour day graph.

Outcome measures

Outcome measures
Measure	CGM Group n=59 Participants Wear an unblinded CGM for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.	SMBG Group n=55 Participants Use SMBG 4 to 7 times a day for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.
Glucose Exposure (Area Under the Diurnal Median Curve)	-615.98 mcg*hr/mL Standard Deviation 924.04	-522.88 mcg*hr/mL Standard Deviation 951.43

SECONDARY outcome

Timeframe: 16 weeks

The secondary objective is to determine the incremental benefit of CGM for clinical decision-making using percent time in hypoglycemia range (\< 50 mg/dL). Numerator: amount of time with a value of 49 mg/dL or less. Denominator: total amount of time of CGM measurement. CGM used for this study produced measurements once every 15 minutes or 360 times per day.

Outcome measures

Outcome measures
Measure	CGM Group n=59 Participants Wear an unblinded CGM for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.	SMBG Group n=55 Participants Use SMBG 4 to 7 times a day for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.
Percent of Time in Hypoglycemia Range	-0.42 % of time in hypoglycemia Standard Deviation 1.88	0.14 % of time in hypoglycemia Standard Deviation 1.22

SECONDARY outcome

Timeframe: Baseline and 16 weeks

Glucose Variability - Interquartile Range used to determine incremental benefit of CGM for clinical decision making. IQR results reflect the change delta from baseline to 16 weeks. IQR is calculated for each subject at each visit. The change in IQR was calculated as final IQR minus baseline IQR. This measure represents an average of the individual subjects IQR delta (baseline to 16 weeks/final).

Outcome measures

Outcome measures
Measure	CGM Group n=59 Participants Wear an unblinded CGM for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.	SMBG Group n=55 Participants Use SMBG 4 to 7 times a day for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.
Change From Baseline in CGM Glucose Variability	-8.36 mg/dL Standard Deviation 15.95	-5.91 mg/dL Standard Deviation 16.73

Adverse Events

CGM Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

SMBG Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CGM Group n=65 participants at risk Wear an unblinded CGM for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.	SMBG Group n=59 participants at risk Use SMBG 4 to 7 times a day for 16 weeks. Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/65 • During the period of the 16 week study. Review every four weeks of SMBG or CGM data as well as patient reported events at each study visit.	1.7% 1/59 • Number of events 1 • During the period of the 16 week study. Review every four weeks of SMBG or CGM data as well as patient reported events at each study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	1.5% 1/65 • Number of events 1 • During the period of the 16 week study. Review every four weeks of SMBG or CGM data as well as patient reported events at each study visit.	0.00% 0/59 • During the period of the 16 week study. Review every four weeks of SMBG or CGM data as well as patient reported events at each study visit.

Additional Information

Dr. Richard Bergenstal

International Diabetes Center

Phone: 952-993-3796

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place