Diabetes Treatment in Rural Guatemala

NCT03626909 | Completed

• 3 other identifiers: 2017-0596A534100SMPH\EMERG MED\EMER MED
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in HgbA1c

  Change in mean percent of HgbA1c compared to value at baseline.

  3,6,9 and 12 months

• Patients meeting their HgbA1c treatment goal

  Percentage of patients meeting treatment goal for HgbA1c compared to this percentage at baseline. Treatment goal will be A1c ≤7 for most patients, A1c ≤8 for patients age 65 or older or who have 2 or more comorbidities, or other individualized goal for select patients as determined by the medical director

  3,6,9 and 12 months

Secondary Outcomes (9)

• Fasting blood glucose

  3, 6, 9 and 12 months

• BMI

  3,6,9 and 12 months

• Waist circumference

  3,6,9 and 12 months

• Blood pressure

  3,6,9 and 12 months

• Diabetic complications

  3,6,9 and 12 months

Interventions

Primary visit and assessment OTHER

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

Follow up visits OTHER

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

3 month visits OTHER

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.

Unscheduled visits OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will include adults 18 years of age and older and will be recruited from the 19 rural villages surrounding San Lucas Tolimán, Guatemala. Treatment of children with diabetes entails greater complexity and is beyond the scope of this program. Though there are no enrollment restrictions based on race or ethnicity, the majority of the people living in these villages are from the Kaqchikel ethnic group, an indigenous Mayan people of the midwestern highlands of Guatemala.

You may qualify if:

• Willing to provide written informed consent
• Willing to comply with all study procedures and be available for the duration of the study
• Male or female, at least 18 years of age
• Prior diagnosis of type 2 diabetes
• Resident of one of the rural communities served by the CHW network of San Lucas Tolimán, Guatemala

You may not qualify if:

• Type 1 diabetes
• Women who are pregnant
• Current use of insulin
• Renal insufficiency (eGRF \<30 mL/min/1.73 m2)
• Unable to provide informed consent -

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Stanford University: collaborator

Study Sites (1)

Hospital Obras Sociales

San Lucas Tolimán, Solala, Guatemala

Location

Related Publications (1)

• Duffy S, Norton D, Kelly M, Chavez A, Tun R, Ramirez MNG, Chen G, Wise P, Svenson J. Using Community Health Workers and a Smartphone Application to Improve Diabetes Control in Rural Guatemala. Glob Health Sci Pract. 2020 Dec 23;8(4):699-720. doi: 10.9745/GHSP-D-20-00076. Print 2020 Dec 23.

  PMID: 33361237 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• James Svenson, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: August 13, 2018
• Study Start: January 14, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)