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CompletedNCT01341067DexlonT2Updated May 2, 2014Results posted

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

An observational study in Type 2 Diabetes Mellitus, sponsored by Rocky Mountain Diabetes and Osteoporosis Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-02.

Sponsored by Rocky Mountain Diabetes and Osteoporosis Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 30 is below the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Rocky Mountain Diabetes and Osteoporosis Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects of all adult ages (18 and older) with type 2 diabetes.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)

Groups and cohorts

  • Basal insulin, approved oral medications
06

What researchers measure

Primary outcomes

  1. Change in HgbA1c

    Time frame: Measured at 6 months

Secondary outcomes

  1. Percentage of Time Spent at Glycemic Levels <65 mg/dl

    Time frame: Measured at baseline and at 6 months

  2. Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl

    Time frame: Measured at baseline and 6 months

  3. Change in Basal Insulin Dose From Baseline Values

    Time frame: Assessed at baseline and 6 months

07

Results

Posted May 2, 2014

Participant flow

Participant flow — Overall Study
MilestoneBasal Insulin, Approved Oral Medications
Started30
Completed26
Not completed4

Outcome measures

PrimaryChange in HgbA1c
Time frame:
Measured at 6 months
Reported as:
Mean · percentage of glycosylated hemoglobin
Change in HgbA1c
percentage of glycosylated hemoglobinBasal Insulin, Approved Oral Medications
Change in HgbA1c-1.9 ± 1.1
SecondaryPercentage of Time Spent at Glycemic Levels <65 mg/dl
Time frame:
Measured at baseline and at 6 months
Reported as:
Mean · percentage of time spent < 65 mg/dl
Percentage of Time Spent at Glycemic Levels <65 mg/dl
percentage of time spent < 65 mg/dlBasal Insulin, Approved Oral Medications
Percentage of Time Spent at Glycemic Levels <65 mg/dl.04 ± 1.0
SecondaryChange in Percentage of Time Spent at Glycemic Levels >180 mg/dl
Time frame:
Measured at baseline and 6 months
Reported as:
Mean · percentage of time spent >180 mg/dl
Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl
percentage of time spent >180 mg/dlBasal Insulin, Approved Oral Medications
Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl-8.5 ± 16.9
SecondaryChange in Basal Insulin Dose From Baseline Values
Time frame:
Assessed at baseline and 6 months
Reported as:
Mean · units of insulin
Change in Basal Insulin Dose From Baseline Values
units of insulinBasal Insulin, Approved Oral Medications
Change in Basal Insulin Dose From Baseline Values0.3 ± 16.7

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Basal Insulin, Approved Oral Medications—0/30 (0%)3/30 (10%)
Most frequent other events
Most frequent other events
EventBasal Insulin, Approved Oral Medications
Insertion site irritationSkin and subcutaneous tissue disorders3/30

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Basal Insulin, Approved Oral Medications
<=18 years0
Between 18 and 65 years21
>=65 years9
Age, Continuous
Age, Continuous(years)Basal Insulin, Approved Oral Medications
Mean58 ± 12.4
Sex: Female, Male
Sex: Female, Male(Participants)Basal Insulin, Approved Oral Medications
Female17
Male13
Region of Enrollment
Region of Enrollment(participants)Basal Insulin, Approved Oral Medications
United States30
08

Study locations

1 site
  • Rocky Mountain Diabetes and Osteoporosis Center
    Idaho Falls, Idaho 83404, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01341067
Lead sponsor
Rocky Mountain Diabetes and Osteoporosis Center
Responsible party
David Liljenquist, M.D. (Primary Investigator, Rocky Mountain Diabetes and Osteoporosis Center) — Principal investigator
First posted
Apr 25, 2011
Start date
Apr 2011
Primary completion
Dec 2011
Completion
Dec 2011
Results posted
May 2, 2014
Last update
May 2, 2014

Study contacts

David R. Liljenquist, MD
principal investigator · Rocky Mountain Diabetes and Osteoporosis Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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