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

NCT04667728 | Completed

• 1 other identifier: 318.17
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

professional continuous glucose monitoring; educational tool; glycemic control

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at 3 Months

  Hemoglobin A1c (%)

  Baseline and 3 months

Other Outcomes (11)

• Change From Baseline in time in range at 3 Months

  Baseline and 3 months

• Change From Baseline in time in hyperglycemic range at 3 Months

  Baseline and 3 months

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

  Baseline and 3 months

Study Arms (2)

intervention group (IGr)

EXPERIMENTAL

The IGr participants wore a professional continuous glucose monitoring (CGM) sensor (iPro™2) during the first six days of the study. Following this period, IGr participants had a medical consultation for the CGM results and treatment adjustments. Additionally, they received a personalized diet plan from a dietitian. After three months, the IGr participants again wore the CGM sensor for one week. These participants also followed the regular institutional Comprehensive Diabetes Care program care plan.

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

control group (CGr)

NO INTERVENTION

The control group followed the regular institutional Comprehensive Diabetes Care program care plan.

Interventions

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

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

intervention group (IGr)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado: lead
• Medtronic, PLC: collaborator

Study Sites (1)

Clínica de Medicina Familiar Oriente

México, 09220, Mexico

Location

Related Publications (5)

• Carlson AL, Mullen DM, Bergenstal RM. Clinical Use of Continuous Glucose Monitoring in Adults with Type 2 Diabetes. Diabetes Technol Ther. 2017 May;19(S2):S4-S11. doi: 10.1089/dia.2017.0024.

  PMID: 28541137 BACKGROUND

• Park C, Le QA. The Effectiveness of Continuous Glucose Monitoring in Patients with Type 2 Diabetes: A Systematic Review of Literature and Meta-analysis. Diabetes Technol Ther. 2018 Sep;20(9):613-621. doi: 10.1089/dia.2018.0177. Epub 2018 Aug 10.

  PMID: 30095980 BACKGROUND

• Taylor PJ, Thompson CH, Brinkworth GD. Effectiveness and acceptability of continuous glucose monitoring for type 2 diabetes management: A narrative review. J Diabetes Investig. 2018 Jul;9(4):713-725. doi: 10.1111/jdi.12807. Epub 2018 Mar 1.

  PMID: 29380542 BACKGROUND

• Bruttomesso D, Laviola L, Avogaro A, Bonora E, Del Prato S, Frontoni S, Orsi E, Rabbone I, Sesti G, Purrello F; of the Italian Diabetes Society (SID). The use of real time continuous glucose monitoring or flash glucose monitoring in the management of diabetes: A consensus view of Italian diabetes experts using the Delphi method. Nutr Metab Cardiovasc Dis. 2019 May;29(5):421-431. doi: 10.1016/j.numecd.2019.01.018. Epub 2019 Feb 10.

  PMID: 30952574 BACKGROUND

• Rivera-Avila DA, Esquivel-Lu AI, Salazar-Lozano CR, Jones K, Doubova SV. The effects of professional continuous glucose monitoring as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes. BMC Endocr Disord. 2021 Apr 23;21(1):79. doi: 10.1186/s12902-021-00742-5.

  PMID: 33888117 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A three-month quasi-experimental study with an intervention and control group and ex-ante and ex-post evaluations

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: May 30, 2017
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)