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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Professional continuous glucose monitoring (CGM) sensor (iPro™2)
Sponsored by
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring professional continuous glucose monitoring, educational tool, glycemic control

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clínica de Medicina Familiar Oriente

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group (IGr)

control group (CGr)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c at 3 Months
Hemoglobin A1c (%)

Secondary Outcome Measures

Full Information

First Posted
December 8, 2020
Last Updated
December 14, 2020
Sponsor
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Collaborators
Medtronic, PLC
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1. Study Identification

Unique Protocol Identification Number
NCT04667728
Brief Title
Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool for Improving Glycemic Control in Patients With Type 2 Diabetes.
Official Title
The Effects of Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool in Patients With Type 2 Diabetes and Poor Glycemic Control
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Collaborators
Medtronic, PLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
professional continuous glucose monitoring, educational tool, glycemic control

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A three-month quasi-experimental study with an intervention and control group and ex-ante and ex-post evaluations
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group (IGr)
Arm Type
Experimental
Arm Description
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.
Arm Title
control group (CGr)
Arm Type
No Intervention
Arm Description
The control group followed the regular institutional Comprehensive Diabetes Care program care plan.
Intervention Type
Device
Intervention Name(s)
Professional continuous glucose monitoring (CGM) sensor (iPro™2)
Intervention Description
Professional continuous glucose monitoring (CGM) sensor (iPro™2) following treatment adjustments and personalized diet plan
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c at 3 Months
Description
Hemoglobin A1c (%)
Time Frame
Baseline and 3 months
Other Pre-specified Outcome Measures:
Title
Change From Baseline in time in range at 3 Months
Description
Percentage of time that patients' continuous glucose monitoring (CGM) glucose readings were in the target range (70-150mg/dl)
Time Frame
Baseline and 3 months
Title
Change From Baseline in time in hyperglycemic range at 3 Months
Description
Percentage of time the patient was in hyperglycemic range (>150 mg/dl)
Time Frame
Baseline and 3 months
Title
Change From Baseline in time in hypoglycemic range at 3 Months
Description
Percentage of time the patient was in hypoglycemic range (<70mg/dl)
Time Frame
Baseline and 3 months
Title
Change From Baseline in average glucose levels at 3 Months
Description
Average glucose levels (mg/dl)
Time Frame
Baseline and 3 months
Title
Change From Baseline in glucose variability at 3 Months
Description
Glucose variability measured through standard deviation
Time Frame
Baseline and 3 months
Title
Change From Baseline in percentage of the area over the blood concentration-time curve at 3 Months
Description
Percentage of the area over the blood concentration-time curve
Time Frame
Baseline and 3 months
Title
Change From Baseline in percentage of the area under the blood concentration-time curve at 3 Months
Description
Percentage of the area under the blood concentration-time curve
Time Frame
Baseline and 3 months
Title
Change From Baseline in daily total caloric intake at 3 Months
Description
Daily total caloric intake (Kcal)
Time Frame
Baseline and 3 months
Title
Change From Baseline in daily carbohydrates intake at 3 Months
Description
Daily carbohydrates intake (Kcal)
Time Frame
Baseline and 3 months
Title
Change From Baseline in daily proteins intake at 3 Months
Description
Daily proteins intake (Kcal)
Time Frame
Baseline and 3 months
Title
Change From Baseline in daily fat intake at 3 Months
Description
Daily fat intake (Kcal)
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clínica de Medicina Familiar Oriente
City
Mexico
ZIP/Postal Code
09220
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no a plan to make individual participant data (IPD) available to other researchers.
Citations:
PubMed Identifier
28541137
Citation
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.
Results Reference
background
PubMed Identifier
30095980
Citation
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.
Results Reference
background
PubMed Identifier
29380542
Citation
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.
Results Reference
background
PubMed Identifier
30952574
Citation
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.
Results Reference
background
PubMed Identifier
33888117
Citation
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.
Results Reference
derived

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

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