Diabetes Treatment in Rural Guatemala

Summary

In this study, the investigators will be using a smartphone application that the investigators developed to guide community health workers through the clinical assessment of patients with diabetes including collection of demographic data and past medical history, assessment of medication history, adherence, and adverse effects, measurement of glycemic control, screening for complications, medication administration and titration, and patient counseling.

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

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• James Svenson, MD, MS · University of Wisconsin, Madison

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-14

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Guatemala

Study Locations