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Completed

NCT Number: NCT04667728

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica de Medicina Familiar Oriente

México, 09220, Mexico

About this study

From May to October 2017, the investigators conducted a three-month pilot study with intervention and control groups and ex-ante and ex-post evaluations in one ISSSTE family medicine clinic in Mexico City. Patients with type 2 diabetes in the comprehensive diabetes care program (MIDE) who were older than 20 years of age and had HbA1c> 8 mg/dL were considered eligible participants for the study; those who agreed to participate, were required to sign an informed consent. In May and June, the investigators invited all consecutive type 2 diabetes patients who attended the MIDE program to join the intervention group; the investigators followed the same protocol in July and August to assemble the control group.

The control group followed the MIDE care plan, consisting of at least two consultations with a medical doctor and HbA1c measurements at baseline and three months later, as well as weekly self-care educational group activities. The baseline consultation included a review of HbA1c levels and treatment adjustments.

At the beginning of the study, the intervention group had a professional CGM device (iPro™2, Medtronic, USA) inserted subcutaneously for six days. Before the CGM insertion, the intervention group received a training session on how to use and calibrate the device through three daily glucometer readings of capillary glucose. Moreover, intervention group patients were trained to record daily information on their medications, including the times and dosages taken; their diet, including the foods and portions consumed; and their physical activity practices. After six days of device use, intervention group participants had a consultation with a family physician trained in diabetes to interpret the CGM report results and adjust their treatment. In addition, a dietitian provided an educational session and personalized diet plan guided by the CGM results. Participants in the intervention group were also advised to attend regular MIDE program activities. After three months, the intervention group wore the sensor again and their HbA1C levels were measured.

After the three-month study period, the intervention and control groups continued their participation in the MIDE program. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with type 2 diabetes with HbA1c>8 mg/dL, without diagnosis of a memory disorder who agreed to participate and signed an informed consent form

Exclusion criteria

  • None

Treatment and study plan

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

Device

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

Primary outcomes

  1. Change From Baseline in HbA1c at 3 Months

    Time frame: Baseline and 3 months

    Hemoglobin A1c (%)

Other outcomes

  1. Change From Baseline in time in range at 3 Months

    Time frame: Baseline and 3 months

    Percentage of time that patients' continuous glucose monitoring (CGM) glucose readings were in the target range (70-150mg/dl)

  2. Change From Baseline in time in hyperglycemic range at 3 Months

    Time frame: Baseline and 3 months

    Percentage of time the patient was in hyperglycemic range (>150 mg/dl)

  3. Change From Baseline in time in hypoglycemic range at 3 Months

    Time frame: Baseline and 3 months

    Percentage of time the patient was in hypoglycemic range (<70mg/dl)

  4. Change From Baseline in average glucose levels at 3 Months

    Time frame: Baseline and 3 months

    Average glucose levels (mg/dl)

  5. Change From Baseline in glucose variability at 3 Months

    Time frame: Baseline and 3 months

    Glucose variability measured through standard deviation

  6. Change From Baseline in percentage of the area over the blood concentration-time curve at 3 Months

    Time frame: Baseline and 3 months

    Percentage of the area over the blood concentration-time curve

  7. Change From Baseline in percentage of the area under the blood concentration-time curve at 3 Months

    Time frame: Baseline and 3 months

    Percentage of the area under the blood concentration-time curve

  8. Change From Baseline in daily total caloric intake at 3 Months

    Time frame: Baseline and 3 months

    Daily total caloric intake (Kcal)

  9. Change From Baseline in daily carbohydrates intake at 3 Months

    Time frame: Baseline and 3 months

    Daily carbohydrates intake (Kcal)

  10. Change From Baseline in daily proteins intake at 3 Months

    Time frame: Baseline and 3 months

    Daily proteins intake (Kcal)

  11. Change From Baseline in daily fat intake at 3 Months

    Time frame: Baseline and 3 months

    Daily fat intake (Kcal)

Sponsors and collaborators

Lead sponsor

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Other Gov

Collaborators

  • Medtronic, PLC

Registry information

Official study title

The Effects of Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool in Patients With Type 2 Diabetes and Poor Glycemic Control

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 16, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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