NCT02293577

Brief Summary

The purpose of this study is to use a continuous glucose monitor (CGM) to describe the day to day blood glucose variability in youth with type 2 diabetes. The hypothesis is that CGM will identify caloric and exercise related variation in blood glucose that is not identified by the subjects' current regimen of intermittent finger stick blood glucose measurements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

November 7, 2014

Last Update Submit

March 4, 2020

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (7)

  • Time with blood glucose >140 mg/dL

    Subjects will be assessed for average amount of time spent with blood sugar \>140, \>200, and \>300 mg/dL across the 5 day study period.

    5 days

  • Glycemic excursion after caloric intake

    Glycemic excursion after caloric intake will be assessed using the mean change (delta) blood glucose meal time to 2-4 hours afterwards over the 5 day study period.

    5 days

  • Glucose area under the curve

    Continuous Glucose Monitoring (CGM) glucose readings will be averaged across the 5 day period and used to obtain the area under the curve.

    5 days

  • Average glucose

    Continuous Glucose Monitoring (CGM) glucose readings will be used to obtain the average glucose levels for subjects across the 5 day period.

    5 days

  • Peak glucose

    Continuous Glucose Monitoring (CGM) glucose readings will be used to obtain the peak glucose level for subjects over the 5 day period.

    5 days

  • Time with blood glucose >200 mg/dL

    Subjects will be assessed for average amount of time spent with blood sugar \>140, \>200, and \>300 mg/dL across the 5 day study period.

    5 days

  • Time with blood glucose >300 mg/dL

    Subjects will be assessed for average amount of time spent with blood sugar \>140, \>200, and \>300 mg/dL across the 5 day study period.

    5 days

Secondary Outcomes (5)

  • Caloric intake

    5 days

  • Total fat intake

    5 days

  • Sugar intake

    5 days

  • Protein intake

    5 days

  • Physical Activity

    5 days

Interventions

continuous glucose monitorDEVICE

In this study all subjects will wear a continuous glucose monitor for 5 days.

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Youth with type 2 diabetes will be recruited from the type 2 diabetes clinic.

You may qualify if:

  • Clinical diagnosis of type 2 diabetes
  • Duration of type 2 diabetes ≥ 3 months
  • Naïve to continuous glucose monitoring
  • Willing to wear a continuous glucose monitor for 5 days
  • Willing to check blood sugar at least every 12 hours, preferably 3 times a day
  • Willing to wear an accelerometer for 5 days
  • Willing to keep a food record for 5 days, including frequent phone contact from the research staff
  • Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
  • Able to give informed consent (for children \<18 years, permission from parents and subject assent will be required)
  • Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods

You may not qualify if:

  • Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
  • Use of any medications (besides insulin and/or metformin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy
  • Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
  • History of hypoglycemic seizure within last year or frequent hypoglycemia (≥2 time a month)
  • Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Pediatric Diabetes Research Program

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michelle Van Name

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2014

First Posted

November 18, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

US(1)