Health Care for Type 1 Diabetes in Developing World
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): basal insulin glargine; standard therapy
Intervention type(s): Drug; Drug
Intervention description(s): Individuals assigned to this arm will initially receive a basal insulin injection daily and gradually be introduced to meal time coverage of blood sugar with additional short acting insulin. Education will like wise proceed in a stepwise manner.; Participants will continue with current mixed insulin treatment using NPH , or lente, and regular insulin .
Other intervention name(s): Lantus
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; basal insulin; developing world; comparative effectiveness