Health Care for Type 1 Diabetes in Developing World

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by University of Pittsburgh
Sponsor:
Collaborators:
National University, Rwanda
Association Rwandese des Diabetiques
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01424046
First received: August 24, 2011
Last updated: August 26, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Drug: basal insulin glargine
Drug: standard therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Differing Type 1 Diabetes Regimens in Youth in the Developing World

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • HbA1c [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    The primary outcome is the level of blood sugar control after 1 years treatment as determined by the Hb A1c test


Secondary Outcome Measures:
  • Microalbuminuria [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Microalbuminuria, the leakage of abnormal amounts of protein in the urine is a major complication of type 1 diabetes and the prevalence of this in the two groups is a secondary outcome


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: basal insulin approach
Participants will be treated primarily with a daily basal insulin injection ( glargine) with later introduction of prandial coverage with a shortacting insulin.
Drug: basal insulin glargine
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.
Other Name: Lantus
Active Comparator: standard therapy
Participants will continue current mixed insulin management and education
Drug: standard therapy
Participants will continue with current mixed insulin treatment using NPH , or lente, and regular insulin .

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.

  Eligibility

Ages Eligible for Study:   1 Year to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424046

Contacts
Contact: Trevor J Orchard, MD 412 383 1032 tjo@pitt.edu
Contact: Sara L Marshall, MPH 412 383 1032 slm90+@pitt.edu

Locations
Rwanda
Association Rwandese des Diabetiques Recruiting
Kigali, Kigali Provence, Rwanda
Principal Investigator: Trevor J Orchard, MD,M Med Sci         
Sponsors and Collaborators
University of Pittsburgh
National University, Rwanda
Association Rwandese des Diabetiques
Investigators
Principal Investigator: Trevor J Orchard, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01424046     History of Changes
Other Study ID Numbers: RC4 pitt 1, RC4DK090809
Study First Received: August 24, 2011
Last Updated: August 26, 2011
Health Authority: United States: Institutional Review Board
Rwanda : National Ethics Committee

Keywords provided by University of Pittsburgh:
type 1 diabetes
basal insulin
developing world
comparative effectiveness

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014