Clinical trial NCT03362762: Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe
Official title: Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: Type 2 diabetes
insulin
Hb1Ac
glycemia
Guadeloupe
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study concerns the type 2 diabetes patients, followed by physicians in Guadeloupe.

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.

Detailed description: Nowadays the set up for insulin treatment is available in general practitioners' offices. However, it is restrained by the reticence of patients and physicians. For type 2 diabetes, insulin therapy is well managed and there is ongoing progress. But there are still some questions about the effect of the treatment in the everyday life of patients: culture, fear, material resources, necessity of education.

Ignorance and prejudices on insulin injection are still prevalent and often it delays for more than a year the time when patients have to switch an insulin treatment for unbalanced chronic disorder.

Type 2 diabetes patients think that the treatment is heavy, can lead to serious hypoglycemia, is uncomfortable for family and can cause fear.

Education of the patients can reduce ignorance and prejudices about insulin treatment.

Nowadays studies show that diabetes patients want to be more involved in the decisions linked to their treatment which impact their perception of the disease and the treatment.

Auto measurement of glycaemia can help the patient better manage his disease and make him understand the importance of controlling his glycaemia levels.

This study could allow to:

* Offer a new care organization for a better use of resources (network, patient therapeutic education...)
* Set up adequate training for professionals and for patients being cared for in medical offices.
* Improve the glycemic balance of patients and slower the growth of degenerative complications.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

• Pregnant or breastfeeding woman

Primary outcomes:
measure: Characteristic of type 2 diabetes patients, treated with insulin in Guadeloupe
timeFrame: Trough study completion, an average of 2 years
Secondary outcomes:
measure: Describe the relation between the rate of HbAC and the plan of insulinothérapie
timeFrame: Trough study completion, an average of 2 years
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: Guadeloupe
facility: University Hospital Center of Pointe-à-Pitre
Study officials:
affiliation: Hospital University Center of Pointe-à-Pitre
name: Pauline NOUVIER KANGAMBEGA, medicine degree, diabetes
role: PRINCIPAL_INVESTIGATOR
References: