Diabetes Mellitus, Type 2NCT04667728
Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool for Improving Glycemic Control in Patients With Type 2 Diabetes.
A study testing Professional continuous glucose monitoring (CGM) sensor (iPro™2) in people with Diabetes Mellitus, Type 2, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Professional continuous glucose monitoring (CGM) sensor (iPro™2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteMexico
- Study dates
- 30 May 2017to 30 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool in Patients With Type 2 Diabetes and Poor Glycemic Control
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Professional continuous glucose monitoring (CGM) sensor (iPro™2)
- Keywords
- professional continuous glucose monitoring, educational tool, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional continuous glucose monitoring (CGM) sensor (iPro™2)Device
Professional continuous glucose monitoring (CGM) sensor (iPro™2) following treatment adjustments and personalized diet plan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c at 3 Months
Hemoglobin A1c (%)
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start30 May 2017
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Sponsor type
- Other government
- Collaborators
- Medtronic, PLC
- Responsible party
- Principal investigator, Dulce Adelaida Rivera Avila, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667728
- Sponsor's protocol ID
- 318.17
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no a plan to make individual participant data (IPD) available to other researchers.
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.
PubMed 28541137Park 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.
PubMed 30095980Taylor 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.
PubMed 29380542Bruttomesso 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.
PubMed 30952574Rivera-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.
PubMed 33888117
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool in Patients With Type 2 Diabetes and Poor Glycemic Control
- ClinicalTrials.gov ID
- NCT04667728
- Acronym / sponsor ID
- 318.17
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- professional continuous glucose monitoring, educational tool, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoOther government
- Collaborators
- Medtronic, PLC
- Study start
- 30 May 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A three-month quasi-experimental study with an intervention and control group and ex-ante and ex-post evaluations
| Arm | Type | Receives |
|---|---|---|
| intervention group (IGr) | Experimental | Device: Professional continuous glucose monitoring (CGM) sensor (iPro™2)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. |
| control group (CGr) | No intervention | –The control group followed the regular institutional Comprehensive Diabetes Care program care plan. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Professional continuous glucose monitoring (CGM) sensor (iPro™2)Professional continuous glucose monitoring (CGM) sensor (iPro™2) following treatment adjustments and personalized diet plan | Device | intervention group (IGr) |
Primary outcome
Change From Baseline in HbA1c at 3 Months
Time frame: Baseline and 3 months
Hemoglobin A1c (%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 28541137Carlson 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.
- Background: PubMed 30095980Park 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.
- Background: PubMed 29380542Taylor 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.
- Background: PubMed 30952574Bruttomesso 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.
- Derived from this study: PubMed 33888117Rivera-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.
- Individual participant dataSharing planned: No. There is no a plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professional continuous glucose monitoring (CGM) sensor (iPro™2) in people with Diabetes Mellitus, Type 2, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in HbA1c at 3 Months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04667728, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.