Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Continuous Glucose Monitoring
Brief summary
The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions related to the management of type 2 diabetes. The secondary objective is to determine the benefit of using CGM for clinical diabetes management decision-making.
Detailed description
This study involves the use of the following 2 glucose monitoring methods to measure your blood sugar (glucose) levels and help manage type 2 diabetes: 1. Self Monitoring Blood Glucose (SMBG): blood glucose is measured 4-7 times each day using finger sticks and an blood glucose meter. 2. Continuous Glucose Monitoring (CGM): blood glucose is measured continuously via the CGM device. This device has been approved for use by the U.S. Food and Drug Administration (FDA).
Interventions
DEVICECGM Group
Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.
DEVICESMBG Group
Fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes. Used CGM blinded once every four weeks.
Sponsors
Roche Diagnostics GmbH
International Diabetes Center at Park Nicollet
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥18 and ≤75 years of age (Upper range to assure dexterity for use of CGM) * Clinical diagnosis of type 2 diabetes * HbA1c ≥7.0% * Diabetes can be treated with any of the following therapies within one month prior to study enrollment: (1) medical nutrition therapy alone or with metformin; (2) sulfonylurea with or without metformin; (3) dipeptidyl peptidase 4 (DPP-4) inhibitor or Glucagon-like peptide-1 (GLP-1) agonist with or without metformin; or insulin with or without metformin.
Exclusion criteria
* Treated with Thiazolidinediones (TZD) * Administered prednisone or cortisone medications in the previous 30 days * Currently pregnant or planning pregnancy during the study period * Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study * HbA1c \<7.0% * Unable to follow the study protocol * Unable to speak, read and write in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change in Hemoglobin A1c | 2 week baseline to 16 week final |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Exposure (Area Under the Diurnal Median Curve) | 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. |
| Percent of Time in Hypoglycemia Range | 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. |
| Change From Baseline in CGM Glucose Variability | 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). |
Countries
United States
Participant flow
Recruitment details
Recruitment Period October 29, 2010 through November 25, 2011. Study Location: Clinic
Participants by arm
| Arm | Count |
|---|---|
| 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. | 65 |
| 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. | 59 |
| Total | 124 |
Baseline characteristics
| Characteristic | SMBG Group | CGM Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 19 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 46 Participants | 93 Participants |
| Age, Continuous | 58.8 years STANDARD_DEVIATION 10 | 59.3 years STANDARD_DEVIATION 8.9 | 59 years STANDARD_DEVIATION 0.9 |
| Region of Enrollment United States | 59 participants | 65 participants | 124 participants |
| Sex: Female, Male Female | 32 Participants | 29 Participants | 61 Participants |
| Sex: Female, Male Male | 27 Participants | 36 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 65 | 1 / 59 |
| serious Total, serious adverse events | 0 / 65 | 0 / 59 |
Outcome results
Primary
Percentage Change in Hemoglobin A1c
Time frame: 2 week baseline to 16 week final
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Group | Percentage Change in Hemoglobin A1c | -1.12 percentage of HbA1c | Standard Deviation 1.07 |
| SMBG Group | Percentage Change in Hemoglobin A1c | -0.82 percentage of HbA1c | Standard Deviation 0.91 |
Secondary
Change From Baseline in CGM Glucose Variability
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).
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Group | Change From Baseline in CGM Glucose Variability | -8.36 mg/dL | Standard Deviation 15.95 |
| SMBG Group | Change From Baseline in CGM Glucose Variability | -5.91 mg/dL | Standard Deviation 16.73 |
Secondary
Glucose Exposure (Area Under the Diurnal Median Curve)
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.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Group | Glucose Exposure (Area Under the Diurnal Median Curve) | -615.98 mcg*hr/mL | Standard Deviation 924.04 |
| SMBG Group | Glucose Exposure (Area Under the Diurnal Median Curve) | -522.88 mcg*hr/mL | Standard Deviation 951.43 |
Secondary
Percent of Time in Hypoglycemia Range
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.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Group | Percent of Time in Hypoglycemia Range | -0.42 % of time in hypoglycemia | Standard Deviation 1.88 |
| SMBG Group | Percent of Time in Hypoglycemia Range | 0.14 % of time in hypoglycemia | Standard Deviation 1.22 |