NCT04245267

Brief Summary

Type 2 diabetes is one of the leading causes of morbidity and mortality rate in Mexico. Although important advances in treatment strategies have been developed in type 2 diabetes mellitus, large gaps exist in achieving quality of care. Few studies have determined the effect of multicomponent interventions in low and middle income countries. The DIABEMPIC program is a quality of care initiative developed by primary care public health services of the Mexico City Government to propitiate diabetes empowerment in people living with type 2 diabetes through an intervention comprised by an interdisciplinary team care, shared medical appointment scheme, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, and guaranteed supply of anti-diabetic medication. The DIABEMPIC program target population consists of patients with type 2 diabetes, without advanced chronic complications, who have regular care in the public primary care services in Mexico city.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

January 24, 2020

Last Update Submit

January 30, 2020

Conditions

Type 2 Diabetes

Keywords

Diabetes outcomesglycemic controlself-carequality of life

Outcome Measures

Primary Outcomes (1)

  • Glycemic control after the program

    HbA1c (%): HbA1c will be compared from the first visit with the last visit (5 months later)

    5 months

Secondary Outcomes (13)

  • Glycemic control after 1 year

    1 year

  • Lipid control

    5 months

  • Weight change

    5 months

  • Blood pressure

    5 months

  • Blood pressure

    1 year

  • +8 more secondary outcomes

Other Outcomes (4)

  • Glycemic control of the patients who attended the program compared with patients attended in primary care units (wait-list)

    5 months

  • Lipid control of the patients who attended the program compared with patients attended in primary care units (wait-list)

    5 months

  • Weight change of the patients who attended the program compared with patients attended in primary care units (wait-list)

    5 months

  • +1 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

Patients in the wait-list being attended with the standard model of care for diabetes in primary care units.

DIABEMPIC program

EXPERIMENTAL

Intervention comprised by an interdisciplinary team care, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, and guaranteed supply of anti-diabetic medication.

Behavioral: DIABEMPIC

Interventions

DIABEMPICBEHAVIORAL

Patients are attended by 9 diabetes health-care professionals every 2 weeks for 5 months in a shared medical appointment scheme, including individual and group sessions. Patients will be evaluated at the end of the program and 1 year after.

DIABEMPIC program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or Women
  • Older than 18 years old, younger than 70 years old
  • Having diagnosis of type 2 diabetes
  • Acceptance for participation in the program by signing informed consent sheet

You may not qualify if:

  • Any other type of diabetes, such as Type 1 diabetes, LADA type Diabetes, gestational diabetes, or any other type of diabetes related to genetic syndromes
  • advanced diabetes complications such as ischemic heart disease, NYHA III-IV heart failure, KDOQI renal failure ≥4, cerebral vascular disease with functional sequelae
  • those who have comorbidities that limit their life expectancy such as malignant tumors in advanced stages
  • Dependence of illicit drugs
  • Conditions that require short-term surgical treatment.
  • Advanced cognitive deficit or serious psychiatric disorders that hinder treatment adherence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Especializada en el Manejo de la Diabetes de la Ciudad de México from the Ministry of Health of the Mexico City Government

Mexico City, Iztapalapa, 09060, Mexico

RECRUITING

Related Publications (3)

  • Aschner P, Gagliardino JJ, Ilkova H, Lavalle F, Ramachandran A, Mbanya JC, Shestakova M, Chantelot JM, Chan JCN. Persistent poor glycaemic control in individuals with type 2 diabetes in developing countries: 12 years of real-world evidence of the International Diabetes Management Practices Study (IDMPS). Diabetologia. 2020 Apr;63(4):711-721. doi: 10.1007/s00125-019-05078-3. Epub 2020 Jan 4.

    PMID: 31901950BACKGROUND

  • Lim LL, Lau ESH, Kong APS, Davies MJ, Levitt NS, Eliasson B, Aguilar-Salinas CA, Ning G, Seino Y, So WY, McGill M, Ogle GD, Orchard TJ, Clarke P, Holman RR, Gregg EW, Gagliardino JJ, Chan JCN. Aspects of Multicomponent Integrated Care Promote Sustained Improvement in Surrogate Clinical Outcomes: A Systematic Review and Meta-analysis. Diabetes Care. 2018 Jun;41(6):1312-1320. doi: 10.2337/dc17-2010.

    PMID: 29784698BACKGROUND

  • Basto-Abreu A, Barrientos-Gutierrez T, Rojas-Martinez R, Aguilar-Salinas CA, Lopez-Olmedo N, De la Cruz-Gongora V, Rivera-Dommarco J, Shamah-Levy T, Romero-Martinez M, Barquera S, Lopez-Ridaura R, Hernandez-Avila M, Villalpando S. [Prevalence of diabetes and poor glycemic control in Mexico: results from Ensanut 2016.]. Salud Publica Mex. 2020 Jan-Feb;62(1):50-59. doi: 10.21149/10752. Spanish.

    PMID: 31869561BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rubén Silva-Tinoco

    Clínica Especializada en Manejo de la Diabetes Gobierno de Ciudad de México

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubén Silva-Tinoco, MD

CONTACT

50381700ruben_ost@hotmail.com

Teresa Cuatecontzi-Xochitiotzi

CONTACT

50381700xochitiotzi1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The effect of the intervention will be determined on the improvement on metabolic parameters, as well as in self care activities and quality of life using a "before and after" design. As a secondary analysis, results will be compared with the population in the wait-list receiving routine care in primary care units. Subjects who attend Clinica Especializada en el Manejo de la Diabetes and meet the selection criteria will be included in this study. Once their admission to the study is decided, subjects may participate in the recruitment and intervention stage and then in the annual follow-up visit stage.
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

January 7, 2017

Primary Completion

January 1, 2021

Study Completion

December 31, 2021

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

Data generated is not publicly available due that data used are from patients and are under policies for private confidential information, but will be available at the end of the study on reasonable request and using unidentifiable IDs. Results are planned to be shared through Journal publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
January 2021. Available for 3 years.
Access Criteria
Undefined

Locations

ME(1)