Diabetes Mellitus, Type 2
Conditions
Keywords
professional continuous glucose monitoring, educational tool, glycemic control
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.
Interventions
DEVICEProfessional continuous glucose monitoring (CGM) sensor (iPro™2)
Professional continuous glucose monitoring (CGM) sensor (iPro™2) following treatment adjustments and personalized diet plan
Sponsors
Medtronic, PLC
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A three-month quasi-experimental study with an intervention and control group and ex-ante and ex-post evaluations
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c at 3 Months | Baseline and 3 months | Hemoglobin A1c (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in time in hyperglycemic range at 3 Months | Baseline and 3 months | Percentage of time the patient was in hyperglycemic range (\>150 mg/dl) |
| Change From Baseline in time in hypoglycemic range at 3 Months | Baseline and 3 months | Percentage of time the patient was in hypoglycemic range (\<70mg/dl) |
| Change From Baseline in average glucose levels at 3 Months | Baseline and 3 months | Average glucose levels (mg/dl) |
| Change From Baseline in glucose variability at 3 Months | Baseline and 3 months | Glucose variability measured through standard deviation |
| Change From Baseline in percentage of the area over the blood concentration-time curve at 3 Months | Baseline and 3 months | Percentage of the area over the blood concentration-time curve |
| Change From Baseline in time in range at 3 Months | Baseline and 3 months | Percentage of time that patients' continuous glucose monitoring (CGM) glucose readings were in the target range (70-150mg/dl) |
| Change From Baseline in daily total caloric intake at 3 Months | Baseline and 3 months | Daily total caloric intake (Kcal) |
| Change From Baseline in daily carbohydrates intake at 3 Months | Baseline and 3 months | Daily carbohydrates intake (Kcal) |
| Change From Baseline in daily proteins intake at 3 Months | Baseline and 3 months | Daily proteins intake (Kcal) |
| Change From Baseline in daily fat intake at 3 Months | Baseline and 3 months | Daily fat intake (Kcal) |
| Change From Baseline in percentage of the area under the blood concentration-time curve at 3 Months | Baseline and 3 months | Percentage of the area under the blood concentration-time curve |
Countries
Mexico
Outcome results
None listed