Diabetes Education With Real-time Continuous Glucose Monitoring

Browse trials for

• Diabetes Mellitus, Type 2 9,359

Keywords

• continuous glucose monitoring
• diabetes education

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 120 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Eligibility criteria

Study arms

• Active comparator
  CGM with DM education

  if you are in the intervention group you will received culturally tailored diabetes education and use a Real Time CGM device to see your glucose over 12 weeks. Both group will completed blinded CGM at the beginning of the study and at 24 weeks

  Device: Dexcom G6

• No intervention
  Education only

  If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks

Interventions

• DeviceDexcom G6

  Dexcom G6 CGM device

  Also known as: Compañeros en Salud (Partners in Health) curriculum

Primary outcomes

1. Hemoglobin A1C

   Percent change in A1C

   Time frame: change at 12 weeks

Secondary outcomes

1. CGM Mean Glucose

   mean glucose at 12 weeks

   Time frame: 12 weeks

2. CGM Percentage of Time in Range

   percentage of time in range( tir)

   Time frame: 12 WEEKS

3. Percent Change in BMI

   percent change BMI ((kg/m2)

   Time frame: change at 12 WEEKS

4. Blood Pressure Systolic

   change in blood pressure

   Time frame: change at 12 WEEKS

5. Physical Activity Questionnaire IPAQ

   increase or decrease in days of vigorous activity - one question in IPAQ.

   Time frame: 12 weeks

6. International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES):

   Question Neighborhood Questionnaire/Neighborhood Safety questions 1 1\. In general, how do you feel about your neighborhood? Do you feel it's a very bad, a fairly bad, a fairly good, or a very good place to live? reported number that felt it was very bad or fairly bad

   Time frame: baseline

7. PHQ9 Depression Score- Those With PHQ9>15

   Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.

   Time frame: 12 weeks

8. PAID-5 Problem Areas in Diabetes Those With Score > 8

   the scale gives a total score from 0 to 20. A score of 8 and above indicates a high level of diabetes-related distress

   Time frame: score at 12 weeks

9. Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care

   The Summary of Diabetes Self-Care Activities asks patient about diabetes self-care activities during the past 7 days and for each activity they can answer 0 days out of the week to a max of 7 days out of the week with higher score indicating more days doing this self -care activity and positive results

   Time frame: composite score at 12 weeks

10. Modified Joslin Diabetes Center CGM Experience

    Experiences of CGM @Joslin 2009 scale range from 5 (strongly agree) to 1 ( strongly disagree) statements/questions that measured the amount of satisfaction that was derived from use of continuous glucose monitoring. Higher score meant perceived benefit/ better outcome

    Time frame: 12 weeks

11. Perception of Behavior Modification After Real-Time- CGM Use

    Did use of Real-Time- cgm in intervention group contribute to a healthier lifestyle ? yes

    Time frame: at 12 weeks

12. Household/Family Member Perception of Lifestyle Changes

    household members perception of lifestyle changes after family member participated in education with CGM. Overall, do you feel Continuous Glucose Monitoring contributed to your making changes for a healthier lifestyle? yes

    Time frame: 12 weeks

13. Pedometer

    average number of steps per day

    Time frame: at 12 weeks

14. Self-Efficacy for Diabetes

    the scale is 1-10 and the score is the mean of the eight items. If more than two items are missing, do not score the scale. Higher number indicates higher self-efficacy

    Time frame: score at 12 weeks

15. Food Insecurity Short Form 6 Question Composite With Score Reported as a Composite: High or Marginal Food Security, Low Food Security, Very Low Food Security

    number of participants that had high or marginal food security based on 6 questions (geared to assess access or lack of access to food) composite score

    Time frame: baseline

Baseline characteristics

Publications

• Ehrhardt N, Cedeno B, Montour L, Sinclair K, Ferguson G, Berberian P, Comstock B, Wright L. Effectiveness of a culturally tailored diabetes education curriculum with real-time continuous glucose monitoring in a Latinx population with type 2 diabetes: the CUT-DM with CGM for Latinx randomised controlled trial study protocol. BMJ Open. 2023 Dec 28;13(12):e082005. doi: 10.1136/bmjopen-2023-082005. PubMed 38154895 ↗

Study documents

• Protocol and statistical analysis plan · Feb 10, 2023
• Informed consent form · Feb 22, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No