Characteristics of Type 2 Diabetes Patients, Treated With Insulin and Their Follow up Care in Guadeloupe (DT2IT)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Other: Description of plans insuliniques used in Guadeloupe in the type 2 diabetes and the characteristics of the handled patients:

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.

• Study Type: Observational
• Enrollment (Actual): 205

Contacts and Locations

Study Locations

• Guadeloupe
  • Pointe-à-Pitre, Guadeloupe, 97159
    • University Hospital Center of Pointe-à-Pitre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the relation between the rate of HbAC and the plan of insulinothérapie	Sreening of HbAC	Trough study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Investigators: Principal Investigator: Pauline NOUVIER KANGAMBEGA, medicine degree, diabetes, Hospital University Center of Pointe-à-Pitre

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2013
• Primary Completion (Actual): September 27, 2016
• Study Completion (Actual): September 27, 2016

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Type 2 diabetes; insulin; glycemia; Guadeloupe; Hb1Ac
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RNI-PAP-913379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No