Health Care for Type 1 Diabetes in Developing World

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a pilot 2-armed, randomized, open label, clinical trial evaluating the effectiveness of a basal approach to diabetes management as compared to the current standard treatment (regular/NPH).

Patients seen at the Association Rwandaise des Diabetiques (ARD) will be invited to participate in the study and consent will be obtained by the investigation team. This will continue until 40 patients have been enrolled at which time recruitment will be started at a provincial hospital, at which 10 further participants will be recruited. Participants will be consenting to 1) Randomization to basal or current insulin treatment arm and 2) Permission for use of clinical data for research.Participants will be followed every six months for a period of 24 months. The first 6 months will be a wash in period and participants will be randomised (1/1) to their treatments at the 6 month visit.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: Association Rwandaise des Diabetiques; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National University, Rwanda
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Type 1 diabetes being treated by the Association Rwandese des Diabetiques

• Resident of Rwanda

Exclusion Criteria:

• life expectancy less than three years

• requiring additional diabetes therapy beyond the scope of the trial