Health Care for Type 1 Diabetes in Developing World
Health Care for Type 1 Diabetes in Developing World
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.
All participants will be provided with the consent form (that has been translated into the
 native language of Kinyarwandan) by the investigators and consent will be obtained from the
 participant if they are aged 18 and older or by parents/guardians if they are under 18 years.
 For those aged 14 - 17 years a child assent will be obtained. For those who are unable to
 read the consent form a patient advocate who will read this form to them and answer any
 questions a potential participant may have. Each person will have time and space to review
 all of the study information and they will be informed that participation is completely
 voluntary and that they will continue to receive their normal care if they do not wish to
 participate. At this visit the following data will be extracted from their clinical files by
 a research assistant under the supervision of Prof Kakoma:

 At all 6 monthly visits (V1-V4), data from the participants' regular clinical visits (based
 on the annual evaluation form for the Life For a Child program) will be extracted. This
 includes HbA1c and microalbuminuria data collection, as well as documentation of: insulin
 regimen, incidents of severe hypo- and hyper-glycemia, symptoms of hyperglycemia, current
 schooling level, number of school days missed due to diabetes, self-rating of diabetes
 control, height, weight, blood pressure, and a basic neurological examination (vibratory
 sensation of great toe and monofilament testing). Information will be abstracted by research
 assistants from the National University of Rwanda (NUR), and education and management
 functions will be carried out by nurses from the ARD that will be trained by Drs Orchard and
 Edidin.

 Each enrolled participant will be followed for a six month period post enrollment on their
 current treatment regimen so the impact of being enrolled in a study rather than an effect of
 their treatment, can be assessed.

 All participants will be supplied with a glucose meter and sufficient strips to test daily.
 These results will also be made available to and reviewed by the ARD staff and will be used
 for further dose adjustment.
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