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Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool for Improving Glycemic Control in Patients With Type 2 Diabetes.

NCT04667728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2020-12-17

No results posted yet for this study

Summary

The investigators conducted a three-month quasi-experimental study with an intervention and control group and ex-ante and ex-post evaluations in one family medicine clinic in Mexico City. Participants were type 2 diabetes patients with HbA1c\>8 mg/dL attending a comprehensive diabetes care program (MIDE). In addition to the program, the intervention group wore a professional CGM sensor (iPro™2) during the first six days of the study. Following this period, intervention group participants had a medical consultation for the CGM results and treatment adjustments. Additionally, the intervention group participants received an educational session and a personalized diet plan from a dietitian. After three months, the intervention group again wore the CGM sensor for one week. The primary outcome variable was HbA1c level measured at baseline and three months after the CGM intervention. The investigators analyzed the effect of the intervention on HbA1c levels by estimating the differences-in-differences treatment effect. Additionally, baseline and three-month CGM and dietary information was recorded for the intervention group and analyzed using the Student's paired t-test and mixed-effects generalized linear models to control for patients' baseline characteristics.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Professional continuous glucose monitoring (CGM) sensor (iPro™2)

Professional continuous glucose monitoring (CGM) sensor (iPro™2) following treatment adjustments and personalized diet plan

Sponsors & Collaborators

  • Medtronic, PLC

    collaborator UNKNOWN

  • Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2017-10-30
Completion
2017-10-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667728 on ClinicalTrials.gov