NCT01237301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 6, 2014

Completed
Last Updated

October 17, 2018

Status Verified

November 1, 2013

Enrollment Period

1.4 years

First QC Date

November 2, 2010

Results QC Date

August 30, 2013

Last Update Submit

October 16, 2018

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesContinuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

  • Percentage Change in Hemoglobin A1c

    2 week baseline to 16 week final

Secondary Outcomes (3)

  • Glucose Exposure (Area Under the Diurnal Median Curve)

    16 weeks

  • Percent of Time in Hypoglycemia Range

    16 weeks

  • Change From Baseline in CGM Glucose Variability

    Baseline and 16 weeks

Study Arms (2)

CGM Group

EXPERIMENTAL

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

SMBG Group

ACTIVE COMPARATOR

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

Interventions

CGM GroupDEVICE

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
CGM Group
SMBG GroupDEVICE

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
SMBG Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Related Publications (1)

  • Mazze RS, Strock E, Wesley D, Borgman S, Morgan B, Bergenstal R, Cuddihy R. Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis. Diabetes Technol Ther. 2008 Jun;10(3):149-59. doi: 10.1089/dia.2007.0293.

    PMID: 18473688BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Richard Bergenstal
Organization
International Diabetes Center
richard.bergenstal@parknicollet.com
952-993-3796

Study Officials

  • Richard M. Bergenstal, MD

    International Diabetes Center at Park Nicollet

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 9, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 17, 2018

Results First Posted

January 6, 2014

Record last verified: 2013-11

Locations

US(1)