Evidence based review of type 2 diabetes prevention and management in low and middle income countries

Table 1 Diabetes management: Diabetes Prevention Program like interventions (allied health professionals and lay member facilitated)

Country	Ref.	Objective	Study design	Sample size/characteristics	Components of intervention	Measurements	Outcome measures	Conclusion
Argentina	Gagliardino et al[29]	To evaluate effect of combined physician and/or patient education and effect of system interventions (100% coverage of medications, formalized data collection)	Randomized 2 × 2 design trial	n = 468, 117 in control group (g1), 117 in physician education group (g2), 117 in patient education group (g3), 117 in physician and patient education group (g4), T2DM for at least 2 yr, age b/w25 and 75 yr	For T2DM pts - 90-120 min weekly teaching units For physicians - 25 structured module interactive course	HbA1c, BMI, FBG	0, 6, 12, 18, 24, 30, 36, 42 mo	HbA1c decreased from 4 mmol/mol to 10 mmol/mol (P < 0.05), with the largest decrease being in g4 (physician and patient education group)
Brazil	Cezaretto et al[30]	To evaluate effect of interdisciplinary intervention program	Two group randomized longitudinal	n = 135, 60 in traditional group, 75 in intensive group, high risk individuals for T2DM between ages 18 and 79	Intensive Intervention group - 2 h group sessions from 4 sessions in month 1 to 2 sessions in month 2 and 1 monthly sessions until 9 mo, print materials, telephone calls, interdisciplinary team included endocrinologist, psychologist, nutritionist, and physical educator	FBS, BMI, post load plasma glucose	0 and 9 mo	Intensive intervention group decreased fasting plasma glucose from 98.9 to 95.3 (P < 0.001), while the traditional intervention group was not significant. Intensive intervention group BMI decreased from 31.7 to 30.9 (P < 0.001) while the traditional intervention group BMI decreased from 29.9 to 29.1 (P < 0.001)
Brazil	Chaves-Fonseca et al[31]	To evaluate effectiveness of “staged diabetes management” protocol	RCT	n = 113, 47 in control group, 66 in intervention group > 30 yr old, T2DM	SDM protocol (as developed International diabetes center) with doctor, nurse, pharmacist and health technicians	HbA1c, random glucose	0, 12 and 18 mo	Random glucose decreased from 12.7 to 10.5 (P = 0.004) and HbA1c decreased from 9.2 to 7.7 (P < 0.001) in intervention group, while there was no significant change in intervention group
Brazil	Mourão et al[49]	To evaluate effectiveness of pharmaceutical care program	RCT	n = 100, 50 in control and interventional, > 18 yr, HbA1c > 7%, post prandial capillary glucose > 180 mg/dL, T2DM	Two research pharmacists conducted education on drug therapy problems, medication adherence	HbA1c, fasting blood glucose	0 and 6 mo	HbA1c decreased -0.6% and fasting blood glucose decreased -21.4 mg/dL in intervention group (P = 0.001)
Brazil	Correr et al[50]	To evaluate effect of pharmacotherapy follow up	RCT	n = 96, 50 in intervention and 46 in control, > 30 yr old, diagnosed T2DM, oral meds or insulin use	Monthly visit with pharmacist for education, suggestion in changes of medication and dosage changes	HbA1c, fasting capillary glycemia	0 and 12 mo	Relative to the control group, the intervention group exhibited greater glycosylated haemoglobin (HbA1) reduction [-2.2% (95%CI, -2.8%: -1.6%) vs -0.3 (95%CI, -0.8:0.2); P < 0.001] and greater fasting capillary glycaemia reduction [-20.1 mg/dL (95%CI, -31.9 mg/dL: -8.3 mg/dL) vs 4.3 mg/dL (95%CI, -13.4 mg/dL: 22.2 mg/dL); P = 0.022]
Brazil	Borges et al[51]	To evaluate effect of pharmaceutical care	Two group experimental	n = 71, 31 in control group and 40 in intervention group, > 18 yr old, T2DM	Individual visit with pharmacist monthly, patient education, dosage adjustment	Fasting glycemia, HbA1c	0 and 12 mo	A significant reduction in the levels of glycosylated haemoglobin was detected in patients in the pharmaceutical caregroup, and an average increase was observed in the control group
Bulgaria	Petkova et al[52]	To evaluate effectiveness of educational programme by pharmacists	Single group	n = 24, 31-75 yr, diagnosed T2DM	Educational Sessions with five teaching units over one month	Blood glucose levels, frequency of hypoglycemic Incidents	0, 1, 3 and 6 mo	Education of diabetic patients by pharmacists can decrease the economic cost of T2DM management and benefit patients. Blood glucose levels decreased from 8 to 7.2 mmol/L (P < 0.05)
Bulgaria	Tankova et al[26]	To evaluate effectives of a teaching program 1 to 2 yr after implementation	RCT	n = 560, 319 in experimental group, 241 in control group, Insulin treated T1 + 2DM	Geneva-Düsseldorf Education Session Model (consists of lessons on DM, practical training on self-control, injection techniques, preparing meals, construction of menu, physical exercise) education is conducted by team of doctors, nurses and rehab therapist using interactive approach	HbA1c, Well-being as measured by 22-item questionnaire	0, 12 and 24 mo	Structured teaching education program improves patient's well being. Improvement in glycemic control of educated patients as compared to control group (P < 0.01) and increase in overall wellbeing (P < 0.001)
Cameroon	Kengne et al[35]	To evaluate effectiveness of nurse-led care	Population based sample participants referred to either one of the 2 rural clinics or one of the 3 urban clinics	n = 225, 39 in rural clinic and 186 in urban, T2DM	Education, clinic visits, monitoring, follow-up	Mean fasting capillary glucose	0 and visit 6 (varied over 1110 patient-months)	Difference in mean levels of fasting glucose between baseline and final visit was 1.6 mmol/L (P < 0.001)
Cameroon	Labhardt et al[36]	To evaluate effectiveness of non-physician clinician facility care	Included all of the 75 clinics in central region of cameroon	n = 79, T2DM	Protocol-drive care by non-physician clinicians (nurses), diet and lifestyle education	Fasting Plasma glucose	0 and 2 yr	Fasting plasma glucose decreased -7.8 mmol/L (P < 0.001)
China	Liu et al[28]	To evaluate effectiveness of group visit and self management model	RCT	n = 176, 98 in intervention group and 78 in control group, T2DM, between 35-80 yr	12 1.5 h sessions on self management education, one-on-one visits with health care providers, including nurse, general practitioner and diabetes specialist	BMI, SBP, DBP	0 and 12 mo	No significant changes in BMI or DBP in either group, significant change in SBP in intervention group of 1.48 (P = 0.04). Larger studies need to be done to determined effects of group visits on blood glucose and other metabolic parameters
China	Chen et al[119]	To evaluate effectiveness of nurse diabetes intervention	Quasi-experiment, pre and post-test	n = 150, 75 in each control and case groups, > 65 yr, diagnosed T2DM, HbA1c > 8.5%	Self-management education with visits lasting 30 min each, telephone follow-up two weekly	BP, HbA1c, Weight	0 and 3 mo	Nurse-led education and consultation is effective in improving management in T2DM patients. HbA1c in case group changed -0.8% (P < 0.001) while the control group had no significant change
Iran	Sarrafzadegan et al[27]	To evaluate effect of comprehensive, community based healthy lifestyle program on cardiometabolic risk factors	Multi-stage cluster, 2 areas	n = 9032, 4179 in intervention area, 4853 in reference area, general population (htn, metabolic syndrome, diabetes, cardiac disease pts)	Public education through mass media, healthy nutrition, increased physical activity, tobacco control and coping with stress	Cholesterol, abdominal obesity, fasting blood glucose	0, 7 yr	Mean fasting blood glucose increased, but prevalence of abdominal obesity, htn, hypercholesterolemia and hypertriglyceridemia decreased significantly in intervention area (P < 0.05), no significant change in prevalence of diabetes
Iran	Farsaei et al[47]	To evaluate effectiveness of pharmacist-led education program	RCT	n = 172, diagnosed T2DM, HbA1c > 7%	Two educational sessions followed by weekly phone calls and appointments, medication consultation	FBS, HbA1c	0 and 3 mo	There is improvement in diabetes management by involvement of pharmacist in multidisciplinary health care team. HbA1c and FBS (-1.7% and -30.8 mg/dL) were decreased in intervention group (P < 0.001)
Jamaica	Less et al[53]	To evaluate effectiveness of involvement of LDFs	Two group experimental	n = 293, 158 in intervention group and 135 in control group, 25-75 yr, diagnosed T2DM	Educational Sessions during 3 monthly visits, self-monitoring forms	HbA1c, BMI	0 and 6 mo	Patient education by LDFs improved glycemic control of T2DM patients. HbA1c reduced from 0.6% in intervention group (P < 0.001) while comparison group had an increase of 0.6% (P < 0.001)
Jordan	Jarab et al[48]	To evaluate effectiveness of pharmacist-led pharmaceutical care intervention program	RCT	n = 171, 85 in intervention group and 86 in control group, > 18 yr, diagnosed T2DM for at least 1 yr, HbA1c > 7.1%	Medication consultation, lifestyle education, follow-up calls 8 weekly	FBG, HbA1c, BMI, Lipid Panel, BP	0 and 6 mo	Pharmacist-led pharmaceutical care led to an improvement in glycemic parameters. Intervention group had a mean reduction of 0.8% HbA1c verses a mean increase of 0.1% in the usual care group (P = 0.019). FBG in intervention group had a reduction of 2.3 mmol/L and the intervention group showed an increase of 0.9 mmol/L (P = 0.014)
Malaysia	Tan et al[33]	To evaluate effectiveness of structured diabetes education program	Single blind RCT	n = 164, 82 in control and intervention group, > 18 yr, diagnosed T1 + T2DM, HbA1c > 7%	Educational sessions once a month for 3 mo self-care practices, individual counseling with nurse and physician	HbA1c, SMBG frequency	0, 1, 2 and 3 mo	A self-management diabetes education program improves the well-being of diabetic patients. Intervention group had lower HbA1c than control group by the end of study (intervention group –P < 0.001, hbac decreased 8.75 ± 1.75; control group 9.67 ± 2.01)
Mexico	Gallegos et al[39]	To evaluate effectiveness of nurse-led education	Two group quasi-experiment	n = 45, 25 in experimental group and 20 in control group, diagnosed T2DM	6 Educational sessions lasting 90 min each, 20 individual counseling sessions lasting 30 to 90 min throughout 50 wk	HbA1c, psychological adaptation, diabetes care skills	0, 3, 6, 9 and 12 mo	Counseling and education model is an effective intervention to improve metabolic control in T2DM patients. HbA1c decreased from 10.36 at baseline to 8.04 (P = 0.000) while comparison group HbA1c levels changed from 9.44 to 9.77
Samoa	DePue et al[37]	To evaluate effectiveness of nurse-community health workers team intervention for diabetes management	Cluster rct	n = 243, 140 in usual care group, 104 in intervention group, > 18 yr, T2DM	Group visits and individual visits based on risk of patients	HbA1c	0 and 12 mo	Mean HbA1c was significantly lower among CHW participants, compared with usual care, after
South Africa	Price et al[40]	To determine long-term glycemic outcome of a structured nurse-led care	Single group, single center	n = 80, T2DM	Nurse led drug titration, structured empowerment based diabetes education	HbA1c, BMI	0, 6 mo, 18 mo, 2 yr, 4 yr	BMI at 6 and 18 mo was significantly higher than at baseline (both P < 0.01), but the 48 mo value was not significantly different from 0 mo. Compared with baseline, HbA1c falls were all significant (P < 0.001 for 6, 18 and 24 mo and P = 0.015 for 48 mo)
South Africa	Gill et al[41]	To determine effectiveness for a nurse-led intervention and education based program	Single group	n = 284, diagnosed T2DM	Self-management education, pictorial based education	HbA1c, BMI	0, 6 and 18 mo	Nurse-led protocol and education based intervention improve glycemic parameters in diabetic patients. HbA1c was 11.6% at baseline, but improved to 7.7% at 18 mo
Thailand	Wattana et al[42]	To evaluate effectiveness of self-diabetes management program	RCT	n = 147, 72 in control and 75 in experimental, > 35 yr, Diagnosed T2DM, FPG > 140 mg	120 min of small group diabetes education class, four 90 min group discussions and two individual home visit sessions by nurse educators	HbA1c, CHD risk, quality of life assessment	0 and 6 mo	A diabetes self-management program is effective in improving metabolic control for T2DM patients. HbA1c change was -0.68 in experimental group (P = 0.029) and 0.07 in control group
Thailand	Navicharern et al[43]	To evaluate effect of multifaceted nurse-coaching intervention	Quasi experiment, 2 group	n = 40, 20 in control and experimental group, T2DM	3 individualized sessions, 2 follow-up phone calls over 12 wk	HbA1c	0 and 3 mo	Mean average of HbA1c of the experimental group was significantly lower than that of the control group [x(exp) = 7.10, SD = 0.67 vs x(cont) = 7.72, SD = 0.97; P ≤ 0.5]
Thailand	Suppapitiporn et al[45]	To evaluate effect of pharmacist led intervention	RCT	n = 360, 180 in control and experimental group each (divided into 4 groups), T2DM	Drug counseling, special medical containers, diabetes booklet (in experimental group, 1 group received only drug counseling, 2nd group received drug counseling + special medical containers, 3rd group received drug counseling + diabetes booklet, 4th group received all)	HbA1c, mean fasting glucose	0, 3, 6 mo	Most favorable glycemic outcome was the group that received all of the interventions; mean FPG was reduced from 147.46 ± 36.07 to 125.38 ± 31.12 mg% (P < 0.000) in 1st visit (3 mo later) and still reducing effect on the 2nd visit (6 mo later) mean FPG from 147.46 ± 36.07 to 130.21
Thailand	Oba et al[44]	To evaluate effectiveness of community participation prevention program in diabetes prevention	Single group, pre-post test	n = 160, > 35 yr, BMI > 23 kg/m2, waist circumference > 80 cm (women) and > 90 cm (men), FBS 100-125 mg/dL, no baseline diabetes (but at risk patients)	Nutritional education provided by nurse practitioner, fitness schedule in daily exercise log	BMI, SBP, DBP	0, 1, 2, 3 mo	Average mean scores of the BMI (P < 0.001), SBP (P < 0.01) and waist circumference (P < 0.01) among persons who were at risk of DM after the intervention were lower than before intervention
Tunisia	Jenhani et al[32]	To evaluate effectiveness of education program on diabetes control	Pre/post-test experiment	n = 87, diagnosed T1 + T2DM, insulin usage	Six education sessions, interactive learning conducted by nurse and general practitioner	HbA1c, BMI, anxiety level	0 and 6 mo	Education program led to an improvement in diabetes control in patients. HbA1c decreased from 8.80% pre intervention to 7.62% (P < 0.000001)
Turkey	Mollaoğlu et al[25]	To evaluate effectiveness of nurse-led planned education	RCT	n = 50, 25 in experimental and control group, 18-65 yr, diagnosed T2DM	3 Educational Sessions 30-40 min each, home visit follow-ups	HbA1c, FBS, lipid panel	0, 1 and 2 mo	Regular, structured, repeated education improves glycemic parameters in T2DM patients, HbA1c and FBS levels changes were not statistically significant
Turkey	Turnacilar et al[46]	To evaluate effectiveness of pharmaceutical care program	Prospective longitudinal, cluster	n = 43, T2DM	6 pharmacy visits, drug counseling, weight control importance	Capillary whole blood glucose, BMI	0, 15, 30, 45, 60, 75, 90 d	Mean fasting blood glucose decreased from 167 to 128 mg/dL (P < 0.001)
Turkey	Kitiş et al[38]	To evaluate effect of home monitoring by public health nurse	Quasi experimental, single group, time series	n = 34, T2DM for at least 2 yr	Caloric calculation, exercise recommendations, medication compliance, monitoring blood glucose, education study group, booklets, 1st two months frequency of visits based on patients needs, with 2nd mo, visits every 2 mo	HbA1c, fasting blood glucose, postmeal blood glucose	0 and 6 mo	HbA1c decreased from 7.3% to 6.7% (P = 0.000), FBG decreased from 186 to 150 (P = 0.001), postmeal blood glucose decreased from 204 to 156 (P = 0.000)

T2DM: Type 2 diabetes mellitus; RCT: Randomized control trial; BMI: Body mass index; HbA1c: Hemoglobin A1c; LDFs: Lay diabetes facilitators.