Diabetes Treatment in Rural Guatemala

CompletedOBSERVATIONAL
Enrollment

89

Participants

Timeline

Start Date

January 14, 2018

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2019

Conditions
Diabetes
Interventions
OTHER

Primary visit and assessment

"At the initial visit on entry into the program CHW will collect information and the application will guide initial treatment and referral recommendations. At this visit:~Collection of demographic information and relevant past medical history Medication history, adherence and side effects Glycemic testing, vital signs, and other anthropometric data. Screening for possible complications of diabetes Recommendations for referrals Medication recommendations and counseling"

OTHER

Follow up visits

CHWs will meet with patients once per month to follow up on adherence and tolerance to medications, assess glycemic control, assess for complications of diabetes, refill medications (with dosing adjustments as needed for side effects, non-adherence or poor glycemic control), and provide diabetic education. These monthly visits will be facilitated by the smartphone application monthly protocol

OTHER

3 month visits

At every 3rd monthly visit, starting with the visit 3 months after enrollment, A1c will be assessed. When A1c is checked, the month 3 medication titration algorithm, is used rather than the monthly titration algorithm, which uses blood glucose. Other than checking A1c and using the A1c-based algorithm as indicated, the procedures performed at the month 3 visit are identical to those of the monthly visit.

OTHER

Unscheduled visits

The CHWs live in the same communities as the patients they will be serving. As such, the investigators recognize that patients may come to them with concerns outside of the structure of monthly visits as described above. The investigators have designed an additional module for the smartphone application that guides the CHWs through an assessment for hypoglycemia or severe hyperglycemia and possible complications of diabetes. If a patient or CHW has a concern outside of the scope of these protocols, the CHW will contact a CHW coordinator and/or the medical director for guidance

Trial Locations (1)

Unknown

Hospital Obras Sociales, San Lucas Tolimán

All Listed Sponsors
collaborator

Stanford University

OTHER

lead

University of Wisconsin, Madison

OTHER

NCT03626909 - Diabetes Treatment in Rural Guatemala | Biotech Hunter | Biotech Hunter