- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04667728
Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool for Improving Glycemic Control in Patients With Type 2 Diabetes.
The Effects of Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool in Patients With Type 2 Diabetes and Poor Glycemic Control
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Mexico, Mexico, 09220
- Clínica de Medicina Familiar Oriente
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention group (IGr)
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.
|
Professional continuous glucose monitoring (CGM) sensor (iPro™2) following treatment adjustments and personalized diet plan
|
No Intervention: control group (CGr)
The control group followed the regular institutional Comprehensive Diabetes Care program care plan.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in HbA1c at 3 Months
Time Frame: Baseline and 3 months
|
Hemoglobin A1c (%)
|
Baseline and 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline and 3 months
|
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)
|
Baseline and 3 months
|
Change From Baseline in time in hypoglycemic range at 3 Months
Time Frame: Baseline and 3 months
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Percentage of time the patient was in hypoglycemic range (<70mg/dl)
|
Baseline and 3 months
|
Change From Baseline in average glucose levels at 3 Months
Time Frame: Baseline and 3 months
|
Average glucose levels (mg/dl)
|
Baseline and 3 months
|
Change From Baseline in glucose variability at 3 Months
Time Frame: Baseline and 3 months
|
Glucose variability measured through standard deviation
|
Baseline and 3 months
|
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
|
Baseline and 3 months
|
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
|
Baseline and 3 months
|
Change From Baseline in daily total caloric intake at 3 Months
Time Frame: Baseline and 3 months
|
Daily total caloric intake (Kcal)
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Baseline and 3 months
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Change From Baseline in daily carbohydrates intake at 3 Months
Time Frame: Baseline and 3 months
|
Daily carbohydrates intake (Kcal)
|
Baseline and 3 months
|
Change From Baseline in daily proteins intake at 3 Months
Time Frame: Baseline and 3 months
|
Daily proteins intake (Kcal)
|
Baseline and 3 months
|
Change From Baseline in daily fat intake at 3 Months
Time Frame: Baseline and 3 months
|
Daily fat intake (Kcal)
|
Baseline and 3 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 318.17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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