Developing a Diabetes CarePak to improve access to safe insulin administration and self-care in Kenya

A century after the discovery of insulin, millions of people living with diabetes (PLWD) cannot obtain or afford the necessary supplies to self-manage their diabetes on a day-to-day basis. Globally, more than 464 million people have diabetes, and the majority live in low- and middle-income countries. More than half of PLWD struggle to access the insulin and other medications they need. Additionally, a portion of this population cannot access the commodities needed to measure their blood glucose (glucometers, test strips, lancets, etc.) or safely administer the insulin (needles and syringes). These challenges were further exacerbated by the COVID-19 pandemic.

This inconsistent access forces PLWD to ration insulin, ration their testing/test strips, and ration or reuse needles. We know that service delivery and access to care for PLWD has been disrupted during COVID-19. According to a World Health Organization survey, 49 percent of the 163 responding countries had partially or completely disrupted services for diabetes or diabetes-related complications. Of those countries reporting disruptions, one of the main reasons for discontinuing services was a shortage of medicines, diagnostics, or other required technologies. For PLWD, erratic access and rationing lead to increased rates of severe complications and even death. Resulting morbidity brings about substantial economic losses to these individuals, their families, and health systems and national economies through direct medical costs and loss of work and wages. This represents a huge unmet need and a call to action for service delivery innovation and disruption.

PLWD spoke of the impact that these access challenges have had on their health, and they made it clear that they wanted to be able to access everything that they needed at the same time and at the same place. At least 90 percent of the PLWD suggested that they typically use a syringe more than three times before disposing of it due to a lack of finances and or a lack of supply of syringes within primary health care facilities. Several PLWD also noted that they had developed sores from reusing blunt syringes.

Developed in close partnership and collaboration with the Kenya Ministry of Health, PLWD, health care providers, patient advocacy/support groups, and professional associations, the Diabetes CarePak is a human-centered “co-packaging” solution that increases access to the combination of medication and associated supplies needed for safe administration of insulin and self-care to improve quality of life and health outcomes.

The CarePak prototype included items such as a glucometer, test strips, lancets, alcohol swabs, a sharps container, a “360 view” tool to monitor glucose levels over time, and educational materials for people living with diabetes. For those individuals who were on insulin, their CarePak prototype contained the needed needles/syringes. The prototype packages were designed to last one month, and then the individuals returned to the health facility for a refill. In addition to improving access to care for people living with diabetes, the project was designed to identify any demonstrated health system benefits and preliminary cost savings for the Kenyan government to advocate for broader uptake if warranted.

Benchmarking other examples of co-packaging/bundling innovations, including ones addressing postpartum hemorrhage, co-packaging of oral rehydration salts and zinc, self-injection for DMPA-SC contraceptive and HIV self-test kits, the CarePak team anchored their work in a human-centered design (HCD) approach. PATH’s Living Labs team uses HDC to work with end users to co-develop solutions aimed at accelerating the pace of innovation, lowering risk, and increasing the likelihood of realizing sustainable solutions. This approach brought together the voices of over 100 individuals in Kenya with lived, clinical, or work expertise in diabetes. The team conducted interviews and focus groups across three counties with PLWD, health care workers, and Ministry of Health officials to understand the needs and barriers to care and to co-create the CarePak prototype, the diabetes self-care educational materials for PLWD, and the training materials for PLWD. This was done to operationalize the “care package” included in the Kenya Ministry of Health 2018 clinical management guidelines for diabetes mellitus.

The CarePak prototype, which included items such as a glucometer, test strips, lancets, needles/syringes (if applicable), and educational materials, was then evaluated by providing it to 23 users with type 1 or type 2 diabetes, across five facilities within the three counties. The users represented a range of clinical needs and demographics. These individuals used the CarePak daily, at home, for two months. Users completed baseline and endline questionnaires, and pre-/post-hemoglobin A1C values were documented. Usability feedback was gathered through home, clinic, and virtual visits.

During the interviews, focus group discussions, and co-creation design sessions, many challenges about access to blood glucose testing products, syringes, and self-care and nutrition information were brought forward. Some of these challenges include:

• Limited diabetes management/self-care knowledge (PLWD were unaware of the type of diabetes they had and correct insulin injection techniques).
• Limited access to personal blood glucose monitoring (> 70 percent of the PLWD did not own monitoring equipment).
• Frequent reuse of needles/syringes due to cost or unreliable availability.
• Frequent visits to multiple facilities to get all supplies due to stockouts.

As individuals received the CarePak, they expressed excitement in the ability to monitor their own blood glucose and secure all the commodities they needed for self-care. Within a short time, they were more comfortable using the machines and the strips, with limited errors.

Following the use of the CarePak, PLWD reported changes in individual lifestyle management. There was an increase in individuals’ self-monitoring of blood glucose, and they reported changes in their diet. Before using CarePak, only one individual had a glucometer at home and measured their blood glucose levels. The rest of the PLWD would have their blood glucose checked only when they went to the clinic for their routine medical visits.

Clinicians reported making clinical management/insulin regimen changes based on the ability to view blood sugar data over time. And finally, there was an observed improvement in clinical outcomes as individuals reported having fewer sores from needle reuse, and there was an average hemoglobin A1C decrease of 2.8 percent over the two-month prototype use period. Health care workers also appreciated the training that was held as part of the CarePak rollout and spoke of the value of the information they learned.

An HCD-led problem-solving approach, with PLWD at the center of the co-creation process, allowed researchers to capture key diabetes self-care and management challenges and the need for a bundle of commodities and to ensure that the CarePak was usable, feasible, and valuable for PLWD, health care workers, and health system stakeholders alike.

The CarePak continues to be iterated on in Kenya, and work is expanding to additional countries in 2022. Given the known challenges within the noncommunicable diseases supply chain and to ensure sustainability of the CarePak long term, Phase 3 work in Kenya will support the use of the CarePak in increasingly larger geographic or administrative areas for the purposes of assessing affordability, availability, the feasibility of sourcing and “kitting,” and patient impact. This phase will also include a high-level market assessment as well as a cost-effectiveness/cost-benefit analysis. As COVID-19 continues to stress supply chains and PLWD, there is a need to continue to strengthen all aspects of self-care, in Kenya and globally.