Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe

NCT03362762 | Completed DMC

• 1 other identifier: RNI-PAP-913379
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes is a major problem of public health in the French West Indies, with an estimated prevalence of 8%, twice more than in France. In Guadeloupe, according to the statistical data of hospital morbidity in 2004, 2643 hospital stays were diagnosed with diabetes. These cases mainly concerned woman (62%) and the elderly, from 45 to 74 years old (67%). The main objective of this research is to describe the insulin protocol used in Guadeloupe for treated type 2 diabetes patients and their characteristics:

• The duration of the type 2 diabetes
• Time elapsing between the diagnosis and the treatment by insulin
• Where the follow up care took place
• Existence of complications Secondary objectives were to describe the link between the HbA1c rate and the insulin therapy protocol. And also to present the main inconveniences expressed by patients and their degree of autonomy.

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

Type 2 diabetes; insulin; Hb1Ac; glycemia; Guadeloupe

Outcome Measures

Primary Outcomes (1)

• Characteristic of type 2 diabetes patients, treated with insulin in Guadeloupe

  A descriptive analysis will be done on the population concerned by the study, for the socio demographic, clinical and therapeutic characteristics. * the duration of the type 2 diabetes, * time elapsing between the diagnostic and the treatment by insulin, * place of the follow up care, * existence of complications.

  Trough study completion, an average of 2 years

Secondary Outcomes (1)

• Describe the relation between the rate of HbAC and the plan of insulinothérapie

  Trough study completion, an average of 2 years

Interventions

Description of plans insuliniques used in Guadeloupe in the type 2 diabetes and the characteristics of the handled patients: OTHER

The physician or the endocrinologist will see the patient during his consultation. The pharmacist will see the patient when he goes to the pharmacy for an insulin treatment. In each case, the patient will be informed about the study, about the medical data that will be collected anonymously. The date will be strictly confidential and under medical secrecy. Then the patient will meet the physician during another consultation at the University Hospital Center of Guadeloupe, in order to collect information's on a questionnaire. Otherwise, the physician can meet the patient at his home, in case he can't move to the University Hospital Center of Guadeloupe.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study concerns the type 2 diabetes patients, followed by physicians in Guadeloupe.

You may qualify if:

• Men or woman
• Age ≥ 18 years old
• Patient with type 2 diabetes, treated with insulin for at least one year
• Patient accepting to participate to the study

You may not qualify if:

• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

University Hospital Center of Pointe-à-Pitre

Pointe-à-Pitre, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Pauline NOUVIER KANGAMBEGA, medicine degree, diabetes

  Hospital University Center of Pointe-à-Pitre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 5, 2017
• Study Start: December 16, 2013
• Primary Completion: September 27, 2016
• Study Completion: September 27, 2016
• Last Updated: December 5, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)