Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on subjects with type 2 diabetes. It is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage their diabetes.
Interventions
None listed
Sponsors
Rocky Mountain Diabetes and Osteoporosis Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with type 2 diabetes mellitus * Have an HgbA1c value ≥ 7% and ≤17%. * Are on basal insulin, with or without oral agents * Are not on basal bolus insulin therapy. * Have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. Severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional. * Have no known allergy to medical tape or sensors. * Are capable of and willing to test their blood glucose (BG) on an average of 4 times per day. * Are willing to not use Acetaminophen while enrolled in the study. * Are willing not to undergo a MRI procedure while wearing the CGM sensor. * Are willing and capable of performing self insertions of the device sensor. * Women of child bearing potential must be willing to use an approved form of birth control while enrolled in the study. * Women of child bearing potential must be willing to perform pregnancy tests monthly while enrolled in the study. * Can understand and speak English fluently.
Exclusion criteria
* Have been on pump therapy in the 6 months prior to enrollment in the study. * Are receiving basal- bolus insulin therapy * Are taking any medication that is not approved to be taken with insulin. * Are pregnant or have intentions of becoming pregnant during the duration of the study. * Have any skin condition that would inhibit the proper wearing of the CGM sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc. * Have a hematocrit ≤30% or ≥55% * Are currently enrolled in another clinical study (subjects must have ended participation in other studies at least 30 days prior to enrolling in this study. * Are employed by any company that manufactures or is developing a CGM device. * Are deemed incapable of participating in the study by the Primary Investigator for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HgbA1c | Measured at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Time Spent at Glycemic Levels <65 mg/dl | Measured at baseline and at 6 months |
| Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl | Measured at baseline and 6 months |
| Change in Basal Insulin Dose From Baseline Values | Assessed at baseline and 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Basal Insulin, Approved Oral Medications Basal insulin, with or without approved oral agents | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Basal Insulin, Approved Oral Medications |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Change in HgbA1c
Time frame: Measured at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Insulin, Approved Oral Medications | Change in HgbA1c | -1.9 percentage of glycosylated hemoglobin | Standard Deviation 1.1 |
Secondary
Change in Basal Insulin Dose From Baseline Values
Time frame: Assessed at baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Insulin, Approved Oral Medications | Change in Basal Insulin Dose From Baseline Values | 0.3 units of insulin | Standard Deviation 16.7 |
Secondary
Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl
Time frame: Measured at baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Insulin, Approved Oral Medications | 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
Percentage of Time Spent at Glycemic Levels <65 mg/dl
Time frame: Measured at baseline and at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Insulin, Approved Oral Medications | Percentage of Time Spent at Glycemic Levels <65 mg/dl | .04 percentage of time spent < 65 mg/dl | Standard Deviation 1 |