An interventional study of CGM Group and SMBG Group in Type 2 Diabetes, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by HealthPartners Institute · Not applicable, Interventional, and Treatment
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.
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:
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 124 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
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Exclusion Criteria:
Wear an unblinded CGM for 16 weeks. Subjects continued previously started medication regiments for their diabetes. Subjects in this arm were randomized to use real time continuous glucose monitoring (rt CGM).
Device: CGM Group
Use SMBG 4 to 7 times a day for 16 weeks. Subjects continued previously started medication regiments for their diabetes. Subjects in this arm were randomized to use structured self monitoring blood glucose (stSMBG) and periodic, blinded continuous glucose monitoring (CGM).
Device: SMBG 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.
Also known as: DexCom SevenPlus CGM, AccuChek Aviva blood glucose meter
Fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes. Used CGM blinded once every four weeks.
Also known as: AccuChek Aviva blood glucose meter, DexCom SevenPlus CGM
Percentage Change in Hemoglobin A1c
Time frame: 2 week baseline to 16 week final
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
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
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
Recruitment Period October 29, 2010 through November 25, 2011. Study Location: Clinic
| Milestone | CGM Group | SMBG Group |
|---|---|---|
| Started | 65 | 59 |
| Completed | 60 | 55 |
| Not completed | 5 | 4 |
| percentage of HbA1c | CGM Group | SMBG Group |
|---|---|---|
| Percentage Change in Hemoglobin A1c | -1.12 ± 1.07 | -0.82 ± 0.91 |
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.
| mcg*hr/mL | CGM Group | SMBG Group |
|---|---|---|
| Glucose Exposure (Area Under the Diurnal Median Curve) | -615.98 ± 924.04 | -522.88 ± 951.43 |
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.
| % of time in hypoglycemia | CGM Group | SMBG Group |
|---|---|---|
| Percent of Time in Hypoglycemia Range | -0.42 ± 1.88 | 0.14 ± 1.22 |
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).
| mg/dL | CGM Group | SMBG Group |
|---|---|---|
| Change From Baseline in CGM Glucose Variability | -8.36 ± 15.95 | -5.91 ± 16.73 |
Collected over During the period of the 16 week study.. Non-serious events are listed at a 0.02% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CGM Group | — | 0/65 (0%) | 1/65 (1.5%) |
| SMBG Group | — | 0/59 (0%) | 1/59 (1.7%) |
| Event | CGM Group | SMBG Group |
|---|---|---|
| CellulitisSkin and subcutaneous tissue disorders | 0/65 | 1/59 |
| Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/65 | 0/59 |
| Age, Categorical(Participants) | CGM Group | SMBG Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 46 | 47 | 93 |
| >=65 years | 19 | 12 | 31 |
| Age, Continuous(years) | CGM Group | SMBG Group | Total |
|---|---|---|---|
| Mean | 59.3 ± 8.9 | 58.8 ± 10 | 59 ± 0.9 |
| Sex: Female, Male(Participants) | CGM Group | SMBG Group | Total |
|---|---|---|---|
| Female | 29 | 32 | 61 |
| Male | 36 | 27 | 63 |
| Region of Enrollment(participants) | CGM Group | SMBG Group | Total |
|---|---|---|---|
| United States | 65 | 59 | 124 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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