Development of a Collaborative Algorithm for the Management of Type 2 Diabetes during Ramadan: An Anchor on Empowerment

Abstract

Empowerment plays significant roles in the complex management of type 2 diabetes. International guidelines have provided recommendations on management of Muslims who fast during Ramadan. However, there remains a lack of patient-centered epistemic tool to empower healthcare providers and patients in managing diabetes during Ramadan. This study discussed the development and evaluation of such tool. The collaborative algorithm was developed with reference to the nominal group technique by a board-certified clinical pharmacist and discussed with endocrinologists, nurses, and family physicians. The empowerment component of the algorithm was developed based on the Basic Psychological Needs Theory. The algorithm was evaluated through a randomized controlled trial. Glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial glucose (PPG) levels and safety profiles in terms of hypoglycemic events were assessed. The collaborative algorithm was developed with four components: screening, education, dose modification by healthcare provider, and dose adjustment by patient. A total of 62 individuals were recruited, with 30 and 32 randomized into the intervention and control groups, respectively. The mean age was 58.4 years, with majority being females (67.7%). There was a reduction in mean HbA1c from 7.9% ± 0.9% to 7.5% ± 0.8% (P < 0.001) in the intervention group, while no significant difference was observed in the control group (P = 0.270). FPG (P < 0.001) and PPG (P = 0.002) also improved significantly in the intervention group. There were no major hypoglycemic events and minor hypoglycemia comparable between both groups (P = 0.465). The collaborative algorithm incorporated empowerment and promoted shared decision-making in diabetes management, hence promoting safe and effective fasting.

Introduction

Empowerment, a psychosocial factor, has gained its credibility in health services since its first recognition in 1988.¹ Since then, the paradigm of chronic disease management has shifted from paternalist models to collaborative models (empowerment paradigm) involving healthcare provider/patient interactions and shared decision-making.¹ As shifts to the empowerment paradigm occur, we also noted a shift in the ideological paradigms underlying the significance of compliance to that of adherence. Adherence refers to conformity to a healthcare plan developed through mutual voluntary agreement between the healthcare provider and the patient.¹

Under the patient-centric model, empowerment is conceptualized as the capability to manage one's own health and illness actively and independently.^2,3 It is significant to consider this psychosocial factor in the management of chronic conditions such as type 2 diabetes mellitus, which includes lifestyle modifications and pharmacotherapeutic changes. Empowerment has also been shown to affect self-care behavior and self-efficacy, which were found to have direct influence on glycemic control.³ Aligning to this finding, interventions have been developed to target patient empowerment with focus on encouraging self-management as measured by perception of health and self-efficacy.⁴ One example was a pharmacist-involved collaborative care model targeting medication adherence and health education, which resulted in glycated hemoglobin (HbA1c) reduction (change: −0.8%, P = 0.019) and an improvement in self-care capabilities of individuals with diabetes.⁵

Evidently, empowerment and self-efficacy play significant roles in the management of diabetes. The complexity of diabetes management stems from variations in lifestyle, medications, physiology, and other factors, which in turn can be affected by another layer of factors such as self-care capability, changes to circadian rhythmicity, and variations in glucose metabolism.⁶ This is especially significant in people who fast during Ramadan. During Ramadan, most Muslims who fast consume two meals a day, which are usually high-caloric food, one before sunrise and the other shortly after sunset.^7,8 Although Islam has exempted Muslims with chronic conditions from fasting, many devoted Muslims still insist on fasting during Ramadan.⁹

The changes in diets, misconception on invasive treatment, and inadequate follow-up by healthcare professionals during Ramadan may compromise patients' safety. Diet and medication mismatch during fasting may increase the risks of both hyperglycemia and hypoglycemia. A large multicenter observational study on 12,243 patients with type 2 diabetes from 13 countries who fast has reported a 7.5-fold and 5-fold increase in the risk of severe hypoglycemia and hyperglycemia, respectively.⁹ The abstinence from food and fluids was also shown to increase the risk of diabetes complications.⁹ This risk may be further aggravated in Muslim-minority countries where Muslims with diabetes might be reluctant to seek advice from healthcare providers due to perceived ethnocultural barriers.^10,11 Moreover, lack of experience among the healthcare professionals in Muslim-minority countries has also resulted in inadequate education and care among Muslims who fast during Ramadan.^8,9

Coupling the complexity of diabetes management and physiological changes to glucose metabolism in individuals who fast during Ramadan, the American Diabetes Association and International Diabetes Federation have provided recommendations on risk assessment, medication dose adjustments by the healthcare providers, dose adjustments through self-monitoring of blood glucose (SMBG), and other self-care techniques.^6,12 However, these recommendations were largely derived from expert consensus and practice experiences among countries from the Middle East and Europe.^6,12 This study therefore took together the recommendations to develop and evaluate an evidence-based collaborative clinical algorithm that incorporated elements of empowerment.

Methods

A collaborative clinical algorithm known as the “Fasting Algorithm for Singaporeans with Type 2 Diabetes” (FAST) (Fig. 1) was developed for the management of type 2 diabetes in Muslims during Ramadan in Singapore. Singapore is a multiethnic country, of which 15% of the residents are Malay.^13,14 As Singapore has a tropical climate without distinctive seasons, the duration of fasting is similar every year, averaged at 13.5 h per day from around 5.30am to 7pm.

FIG. 1.

Collaborative clinical algorithm anchoring on empowerment for the management of type 2 diabetes during Ramadan.

Development of FAST

FAST was developed with reference to the nominal group technique,¹⁵ a consensus method commonly used in health services research. First drafted by a board-certified ambulatory care clinical pharmacist, the algorithm was then discussed and evaluated among endocrinologists, family physicians, nurses, and pharmacists. This algorithm adopted elements of empowerment from the Basic Psychological Needs Theory.¹⁶ This theory argues that psychological well-being is predicted on autonomy, competence, and feeling of closeness and belonging to a social group.¹⁶

FAST was developed into an epistemic tool with four components: screening, education, dose modification by healthcare provider, and dose adjustment through SMBG. The multidisciplinary panel recommended FAST to be dedicated to Muslims with HbA1c ≤9.5%, no history of recurrent hypoglycemia, having an estimated glomerular filtration rate (eGFR) ≥30 mL/min, and other screening criteria listed in Figure 1. These screening criteria were determined based on recommendations from international guidelines and findings from two trials conducted by the study team on individuals with type 2 diabetes who fast in Singapore.^17,18 With the screening criteria in place, it will aid healthcare providers, especially those whose knowledge level on Ramadan fasting can be further improved, in identifying Muslims who may be suitable to fast.¹¹

FAST also guided healthcare providers to educate individuals with diabetes on SMBG, hypoglycemia management, nutrition, and Ramadan-related misconceptions. This type of individualized education was found to reduce incidence of hypoglycemia and improve glycemic control.¹⁹ This component of the algorithm was developed based on the autonomy and competence constructs of the Basic Psychological Needs Theory to empower Muslims with the knowledge in taking charge of their medical condition.¹⁶

FAST subsequently set out the medication adjustment guidance for healthcare professionals. The guidance was drafted from consultation with international guidelines and established literature,^6,12,20 categorizing into oral hypoglycemic agents and insulin. Sodium–glucose cotransporter-2 (SGLT-2) inhibitors, dipeptidyl peptidase IV (DPP-IV) inhibitors, and thiazolidinediones were recommended to be taken at iftar (i.e., with sunset meal) instead of at sahur (i.e., with predawn meal). While SGLT-2 inhibitors were associated with a low risk of hypoglycaemia,²¹ they were found to cause mild dehydration potentially leading to orthostatic hypotension.²² This could be more pertinent in Muslims who fast and are not able to consume sufficient fluids during the day. In addition, lack of fluid consumption may increase the risk of urinary tract infections.²¹ Considering safety, FAST recommended SGLT-2 inhibitors to be taken at iftar when individuals can consume sufficient fluids. DPP-IV inhibitors and thiazolidinediones were also recommended to be taken with the sunset meal in view of adherence and convenience as many other oral antidiabetic agents were taken at iftar. Metformin is recommended to be adjusted with a larger dose to coincide with the sunset meal and a relatively smaller dose with the predawn meal. For oral diabetic medications targeting postprandial hyperglycemia such as sulfonylureas, meglitinides, and alpha-glucosidase inhibitors, the total daily dose is divided with a larger proportion to be taken with the sunset meal. This recommendation accounted for the higher carbohydrate-containing meal taken at iftar.^23,24 In general, insulin dose taken with predawn meal is recommended to be reduced by 10%–20% to minimize hypoglycemic risk.

This epistemic tool also focuses on active management by Muslims with diabetes. Recommendations for dose adjustment are provided based on SMBG readings. This novel incorporation of active self-management with evidence-based clinical management aimed to promote self-efficacy and subsequently improve the clinical outcomes of Muslims with diabetes.³ This component was developed with reference to self-determination theory that pushed for intrinsic and extrinsic motivation to enhance performance and persistence of individuals in managing their diabetes.²⁵ The algorithm recommended dose adjustment with a focus on diabetic agents that affect postprandial glucose (PPG) level.^6,12,25 Empowering individuals to play an active role in managing their diabetes can improve self-care behavior, which has been well-established in the literature to improve clinical outcomes of diabetes.²⁶

Evaluation of FAST

With the interprofessional panel consensus on this algorithm, FAST was tested for user-friendliness among Muslim patients and clinicians.²⁷ Subsequently, a pilot study on its effectiveness, approved by the Singapore National Healthcare Group Domain Specific Review Board, was conducted at a primary care institution and tertiary hospital in Singapore. Individuals aged 21 years and older, diagnosed with type 2 diabetes with baseline HbA1c ≤9.5%, and who fasted for at least 10 out of 30 days during Ramadan were eligible. Individuals with an eGFR of <30 mL/min at baseline, taking short-term oral corticosteroid, had recurrent hypoglycemia, and diabetes-related hospitalization 1 month before Ramadan were excluded.

Eligible individuals were randomized into the intervention group (use of FAST) or the control group (usual care without use of FAST). Clinical outcomes such as HbA1c, fasting plasma glucose (FPG), and PPG collected before, during, and after Ramadan were evaluated. Major and minor hypoglycemic events were also evaluated. Major hypoglycemic events were defined as any hypoglycemic symptoms that require the help from another person.²⁸ Minor hypoglycemic events should allow the patient to recover quickly with or without the ingestion of fast-acting glucose.²⁸ Statistical analyses were conducted using SPSS (V24.0; SPSS, Inc., Chicago, IL). All statistical tests were two tailed with a significance level (α) of 0.05. Tests of differences between the two groups were conducted using Student's t-test or Mann–Whitney U test for continuous variables as appropriate.

Results

A total of 72 individuals were approached and 62 (86.1%) individuals were found to be eligible and they were randomized into the intervention group (n = 30) and the control group (n = 32).

The mean age of the overall participants was 58.4 ± 11.3 years. Majority of the participants were Malay (n = 60, 96.8%) and female (n = 42, 67.7%). The average number of fasting days was 25 ± 9 and 27 ± 5 days in the intervention and control group, respectively (P = 0.173). The mean duration of diagnosis with diabetes was 12.9 ± 10.5 years in the intervention group and 11.6 ± 10.3 years in the control group (P = 0.608). The baseline HbA1c level was not significantly different between both groups (intervention: 7.9% ± 0.9% vs. control: 7.8% ± 1.0%, P = 0.549). The differences in other baseline characteristics between both groups were also insignificant.

There was an improvement in mean HbA1c from 7.9% ± 0.9% before Ramadan to 7.5% ± 0.8% during Ramadan (P < 0.001) in the intervention group, while no significant difference in mean HbA1c was observed in the control group (P = 0.270) (Table 1). There was an improvement in FPG in the intervention group and this improvement was greater than that observed in the control group (Table 1). In terms of PPG, there was an increase in the intervention group (Table 1). This could be attributed to changes in food intake and lifestyle during Ramadan, where patients consume large amounts of simple carbohydrates in a short period of time before fasting start and after breaking fast.²⁹ Overall, there were no major hypoglycemic events reported and minor hypoglycemia events were comparable among the two groups (intervention group, n = 14 vs. control group, n = 12) (P = 0.465).

Table 1.

Clinical Results from Usage of FAST Compared with Usual Care Without FAST

	Change over Ramadan
	Intervention	Control
HbA1c, %	−0.4 ± 0.6^*	−0.1 ± 0.5
FBG, mmol/L	−1.6 ± 2.5^*	−0.2 ± 2.1^*
PPG, mmol/L	+1.6 ± 4.4^*	+0.9 ± 2.5

P < 0.05.

HbA1c, glycated hemoglobin; FBG, fasting blood glucose; PPG, postprandial glucose.

FAST, Fasting Algorithm for Singaporeans with Type 2 Diabetes.

After adjusting for average number of fasting days, baseline HbA1c, and baseline FPG, the change in HbA1c before and during Ramadan between the study groups remained significant. Taken together, individuals whose diabetes was managed using FAST attained greater improvement in HbA1c and FPG safely. However, the application of this algorithm to other settings should be done with caution as it was developed in Singapore in which the duration of fasting is similar across the year. The differences in fasting practices across the globe may limit the generalizability of FAST and the findings. Nonetheless, FAST can be a viable and beneficial option for adaptation to diabetes management during Ramadan.

Conclusion

FAST appeared to be promising, and hence, its implementation was prompted to a primary care medical facility and a tertiary hospital in Singapore, in which its clinical and humanistic effectiveness is currently being evaluated through a randomized clinical trial (NCT03314246). Taken together, FAST is a collaborative clinical tool, supported by theories and sociological perspectives that incorporated empowerment and promoted shared decision-making in diabetes management. This was one of the first evidence-based patient-centered clinical algorithms developed with an emphasis on increased patient/physician interaction, self-management, and individualized care. FAST also targeted barriers to guideline implementation by educating Muslims on diabetes and Ramadan fasting, providing guidance for healthcare providers from a Muslim-minority country to manage this group of individuals. Furthermore, collective empowerment can lead to improved clinical outcomes, promotion of positive behavioral changes, improved diabetes knowledge, and self-care capabilities.³⁰ The development of FAST prompted further studies to implement this culturally tailored clinical tool to promote safe and effective fasting for Muslims with type 2 diabetes.

Footnotes

Acknowledgments

The authors acknowledge the coinvestigators from Tan Tock Seng Hospital, including Dr. Seow Cherng Jye, Dr. Lee Ying Shan, Dr. Kon Yin Chian Winston, Dr. Quek Peng Lim Timothy, Dr. Lim Su Ping Brenda, Dr. Tan Wai Kit Alvin, Dr. Hoi Wai Han, Dr. Tan Seng Kiong, Dr. Yeo Pei Shan, Dr. Stanley Lam, Dr. Chin Han Xin, and Ms. Chu Shen Onn, for their clinical and administrative contributions to the study. The authors also acknowledge the coinvestigators from the National University Polyclinics, including Dr. Wong Sze Mun Cynthia, Dr. Taiju Rangpa, Dr. Khaw Mei Lin, Ms. Bek Siew Joo Esther, and Ms. Nur'Ain Bte Abdul Manan, for their clinical and administrative contributions to the study. This research was supported by the Academic Research Fund (AcRF) Tier 1 Grant from the Ministry of Education Singapore, awarded to A/Prof Joyce Yu-Chia Lee.

Author Disclosure Statement

No competing financial interests exist.

References

McAllister

, Dunn

, Payne

, et al.: Patient empowerment: the need to consider it as a measurable patient-reported outcome for chronic conditions. BMC Health Serv Res, 2012; 12:157.

Lutfey

, Wishner

: Beyond “compliance” is “adherence.” Improving the prospect of diabetes care. Diabetes Care, 1999; 22:635–639.

Lee

Y-J

, Shin

S-J

, Wang

R-H

, et al.: Pathways of empowerment perceptions, health literacy, self-efficacy, and self-care behaviors to glycemic control in patients with type 2 diabetes mellitus. Patient Educ Couns, 2016; 99:287–294.

Lorig

, Ritter

, Villa

, Armas

: Community-based peer-led diabetes self-management: a randomized trial. Diabetes Educ, 2009; 35:641–651.

Jarab

, Alqudah

, Mukattash

, et al.: Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan. J Manag Care Pharm, 2012; 18:516–526.

International Diabetes Federation: Guidelines. Diabetes and Ramadan: Practical Guidelines. www.idf.org/e-library/guidelines/87-diabetes-and-ramadan-practical-25 (accessed February 21, 2018 ).

Vasan

, Karol

, Mahendri

, et al.: A prospective assessment of dietary patterns in Muslim subjects with type 2 diabetes who undertake fasting during Ramadan. Indian J Endocrinol Metab, 2012; 16:552–557.

Babineaux

, Toaima

, Boye

, et al.: Multi-country retrospective observational study of the management and outcomes of patients with type 2 diabetes during Ramadan in 2010 (CREED). Diabet Med J Br Diabet Assoc, 2015; 32:819–828.

Salti

, Bénard

, Detournay

, et al.: A population-based study of diabetes and its characteristics during the fasting month of Ramadan in 13 countries: results of the epidemiology of diabetes and Ramadan 1422/2001 (EPIDIAR) study. Diabetes Care, 2004; 27:2306–2311.

10.

Gaborit

, Dutour

, Ronsin

, et al.: Ramadan fasting with diabetes: an interview study of inpatients' and general practitioners' attitudes in the South of France. Diabetes Metab, 2011; 37:395–402.

11.

Zainudin

, Hussain

: The current state of knowledge, perception and practice in diabetes management during fasting in Ramadan by healthcare professionals. Diabetes Metab Syndr, 2017; 12:337–342.

12.

Ibrahim

, Abu Al Magd

, Annabi

, et al.: Recommendations for management of diabetes during Ramadan: update 2015. BMJ Open Diabetes Res Care, 2015; 3:e000108.

13.

Ministry of Health: National Health Survey 2010. www.moh.gov.sg/content/moh_web/home/Publications/Reports/2011/national_health_survey2010.html (accessed February 21, 2018 ).

14.

Department of Statistics, Ministry of Trade & Industry, Singapore: Population Trends 2016. www.singstat.gov.sg/docs/default-source/default-document-library/publications/publications_and_papers/population_and_population_structure/population2016.pdf (accessed February 21, 2018 ).

15.

McMillan

, King

, Tully

: How to use the nominal group and Delphi techniques. Int J Clin Pharm, 2016; 38:655–662.

16.

Deci

, Ryan

: Handbook of Self-Determination Research. Rochester, NY: The University of Rochester Press, 2002.

17.

Siaw

MYL

, Chew

DEK

, Dalan

, et al.: Evaluating the effect of Ramadan fasting on Muslim patients with diabetes in relation to use of medication and lifestyle patterns: a prospective study. Int J Endocrinol, 2014; 2014:308546.

18.

Siaw

MYL

, Chew

DEK

, Toh

MPHS

, et al.: Metabolic parameters in type 2 diabetic patients with varying degrees of glycemic control during Ramadan: an observational study. J Diabetes Investig, 2016; 7:70–75.

19.

McEwen

, Ibrahim

, Ali

, et al.: Impact of an individualized type 2 diabetes education program on clinical outcomes during Ramadan. BMJ Open Diabetes Res Care, 2015; 3:e000111.

20.

Ahmedani

, Haque

, Basit

, et al.: Ramadan prospective diabetes study: the role of drug dosage and timing alteration, active glucose monitoring and patient education. Diabet Med, 2012; 29:709–715.

21.

Monami

, Nardini

, Mannucci

: Efficacy and safety of sodium glucose co-transport-2 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Diabetes Obes Metab, 2014; 16:457–466.

22.

Schwartz

, Ahmed

: Sodium-glucose cotransporter 2 inhibitors: an evidence-based practice approach to their use in the natural history of type 2 diabetes. Curr Med Res Opin, 2016; 32:907–919.

23.

Hossain

, Zehra

: Diabetes and diet in Ramadan. J Pak Med Assoc, 2015; 65(5 Suppl 1):S72–S75.

24.

Ali

, Davies

, Brady

, et al.: Guidelines for managing diabetes in Ramadan. Diabet Med, 2016; 33:1315–1329.

25.

Dannapfel

, Peolsson

, Ståhl

, et al.: Applying self-determination theory for improved understanding of physiotherapists' rationale for using research in clinical practice: a qualitative study in Sweden. Physiother Theory Pract, 2014; 30:20–28.

26.

D'Souza

, Karkada

, Hanrahan

, et al.: Do perceptions of empowerment affect glycemic control and self-care among adults with type 2 diabetes?. Glob J Health Sci, 2015; 7:80–90.

27.

See Toh

, Lim

, Abdul Shakoor

SAKK

, et al.: Fasting Algorithm for Singaporeans with Type 2 Diabetes (FAST) During Ramadan: A Prospective Multicenter, Pilot Study. In: ACCP Annual Meeting. Pheonix, Arizona; 2017.

28.

Lee

JY-C

, Tsou

, Lim

, et al.: “Symptom-based Insulin adjustment for Glucose Normalization” (SIGN) Algorithm: a Pilot Study. Diabetes Technol Ther, 2012; 14:1145–1148.

29.

Norouzy

, Mohajeri

SMR

, Shakeri

, et al.: Effect of Ramadan fasting on glycemic control in patients with type 2 diabetes. J Endocrinol Invest, 2012; 35:766–771.

30.

Baldoni

, Aquino

, Sanches-Giraud

, et al.: Collective empowerment strategies for patients with diabetes mellitus: a systematic review and meta-analysis. Prim Care Diabetes, 2017; 11:201–211.