Background
Methods
Ethical approval
Study design
Sample size
Study settings
Patient recruitment
Randomization
Baseline evaluation
Blinding
Trial registration
Missing data or dropouts
Study population
Inclusion criteria
Exclusion criteria
Research procedures
Pharmaceutical care plan
Physician collaboration
Patient-pharmacist interaction
Description of Pharmacist’s intervention
Pharmacist work up for drug therapy (PWDT)
Pharmacological interventions (DRPs)
Oral hypoglycemic agents and insulin administration
Medication adherence and treatment goals
Dietary and lifestyle modifications
Self-monitoring of blood glucose (SMBG)
Assessment of diabetic complications and diabetic foot care
Counselling for personal care and hygiene
Outcome measures
Primary outcome measures
Secondary outcome measures
Funding
Data analysis
Results
Overall participants baseline demographics and clinical characteristics
Participants baseline characteristics; control vs intervention
Clinical Characteristics of Participants in Two Study Arms (At Baseline) [Mean ± SD] | |||
---|---|---|---|
Parameters | Control Arm, n = 121 | Intervention Arm, n = 123 | p–values |
Age (Yrs)
| 50.4 ± 7.7 | 50.3 ± 10.5 | 0.89 |
Age at diagnosis of DM(Yrs)
| 42.8 ± 7.9 | 44.2 ± 9.8 | 0.24 |
Duration of DM (Yrs)
| 7.6 ± 5.4 | 6.1 ± 5.3 | 0.029* |
Haemoglobin (mg/dL)
| 13.2 4 ± 1.1 | 13.9 ± 1.1 | 0.69 |
Weight (Kg)
| 78.3 ± 14.4 | 77.5 ± 17.6 | 0.72 |
Waist (cm)
| 110 ± 16.5 | 109 ± 16.5 | 0.86 |
BMI (Kg/m
2
)
| 30.6 ± 4.9 | 30.8 ± 6.4 | 0.79 |
Systolic BP (mmHg)
| 133 ± 15.4 | 145 ± 20.9 | 0.0001** |
Diastolic BP (mmHg)
| 85 ± 10.4 | 94 ± 10.7 | 0.0001** |
eABG (mg/dL)
| 261 ± 49.8 | 268 ± 50.2 | 0.25 |
HbA1c
| 10.7 ± 1.7 | 11.0 ± 1.7 | 0.25 |
Cholesterol (mg/dL)
| 231 ± 55.7 | 223 ± 51.3 | 0.26 |
Triglycerides(mg/dL)
| 191 ± 79.7 | 272 ± 112.1 | 0.0001** |
HDL-C (mg/dL)
| 48 ± 12.5 | 49 ± 18.2 | 0.45 |
LDL-C (mg/dL)
| 145 ± 48.5 | 119 ± 50.3 | 0.0001** |
VLDL-C (mg/dL)
| 38 ± 15.9 | 54 ± 22.4 | 0.0001** |
Serum Creatinine (mg/dL)
| 1.0 ± 0.3 | 1.1 ± 0.4 | 0.007* |
Treatments | |||
None | 2 (1.7%) | 1 (0.8%) | |
OHA | 66 (54.5%) | 72 (58.5%) | 0.51 |
OHA + Insulin | 43 (35.5%) | 45 (36.6%) | |
Insulin | 10 (8.3%) | 5 (4.1%) |
Intra and inter-group comparisons of process outcome measures
Process Outcome Measures Intra-group comparison; baseline vs follow-ups Inter-group comparison; final control vs final intervention [Mean ± SD] | FC vs FI (p-values) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Process Outcomes | Control Arm | Intervention Arm | |||||||||
Baseline, n = 121 | Follow up Every 3 Months | p-values | Baseline, n = 123 | Follow up Every 3 Months | p-values | ||||||
1st, n = 121 | 2nd, n = 121 | 3rd, n = 52 | 1st, n = 123 | 2nd, n = 105 | 3rd, n = 83 | ||||||
Weight [Kg] | 78.2 ± 14.4 | 78.4 ± 15.1 | 78.8 ± 14.9 | 76.3 ± 14.8 | 0.915 | 77.5 ± 17.6 | 75.9 ± 16.9 | 74.6 ± 16.2 | 73.7 ± 16.6 | 0.258 | 0.35 |
Waist [cm] | 110 ± 16.6 | 109 ± 16.1 | 110 ± 16.2 | 106 ± 14.3 | 0.567 | 109 ± 16.5 | 107 ± 15.9 | 105 ± 15.3 | 103 ± 13.6 | 0.042* | 0.28 |
BMI [Kg/m2] | 30.6 ± 4.9 | 30.6 ± 5.1 | 30.8 ± 5.1 | 30.7 ± 5.6 | 0.986 | 30.7 ± 6.4 | 30.2 ± 6.2 | 29.4 ± 5.9 | 28.9 ± 5.9 | 0.131 | 0.06 |
HbA1c (%) | 10.7 ± 1.7 | 10.6 ± 2.1 | 10.2 ± 1.9 | 9.7 ± 1.3 | 0.001** | 11 ± 1.7 | 9.5 ± 1.6 | 8.4 ± 1.1 | 7.7 ± 0.9 | 0.0001** | 0.0001** |
eABG [mg/dL] | 261 ± 49.8 | 257 ± 58.9 | 246 ± 54.7 | 232 ± 38 | 0.0036* | 268 ± 50.2 | 227 ± 44.8 | 194 ± 32.1 | 174 ± 25.6 | < 0.0001** | 0.025* |
SBP [mm/Hg] | 133 ± 15.4 | 132 ± 13.4 | 134 ± 13.2 | 137 ± 7.1 | 0.082 | 145 ± 20.9 | 133 ± 14.2 | 127 ± 10.6 | 124 ± 9.9 | < 0.0001** | 0.0001** |
DBP [mm/Hg] | 85 ± 10.4 | 85 ± 7.9 | 86 ± 9.8 | 89 ± 4.2 | 0.03* | 94 ± 10.7 | 89 ± 7.1 | 88 ± 6.1 | 87 ± 5.4 | < 0.0001** | 0.0001** |
Cholesterol [mg/dL] | 231 ± 55.7 | 229 ± 49.6 | 223 ± 43.7 | 221 ± 53.2 | 0.3 | 223 ± 51.3 | 187 ± 36.6 | 169 ± 28.1 | 153 ± 25.9 | < 0.0001** | 0.0001** |
TG [mg/dL] | 191 ± 79.8 | 186 ± 67.7 | 175 ± 53.1 | 172 ± 48.7 | 0.1 | 272 ± 112.1 | 195 ± 53.9 | 164 ± 39.9 | 143 ± 31.6 | < 0.0001** | 0.0001** |
HDL-C [mg/dL] | 48 ± 12.5 | 46 ± 10.9 | 47 ± 12.3 | 49 ± 13.9 | 0.437 | 49 ± 18.2 | 50 ± 11.4 | 49 ± 9.7 | 49 ± 7.9 | 0.975 | 0.794 |
LDL-C [mg/dL] | 145 ± 48.5 | 146 ± 43.1 | 141 ± 39.4 | 82 ± 77.9 | < 0.0001** | 119 ± 50.3 | 99 ± 34.4 | 87 ± 26.1 | 76 ± 21.7 | < 0.0001*** | 0.0001** |
VLDL-C [mg/dL] | 38 ± 15.9 | 37 ± 13.5 | 35 ± 10.6 | 20 ± 18.5 | < 0.0001** | 54 ± 22.4 | 39 ± 10.8 | 33 ± 8 | 29 ± 6.3 | < 0.0001** | 0.0001** |
S Cr [mg/dL] | 1.0 ± 0.3 | 1 ± 0.2 | 1.0 ± 0.2 | 1 ± 0.1 | 0.8 | 1.1 ± 0.4 | 0.9 ± 0.2 | 0.9 ± 0.2 | 0.8 ± 0.1 | < 0.0001** | 0.0001** |
eGFR [ml/min/1.73m2] | 77 ± 18.1 | 77 ± 15.8 | 76 ± 16.2 | 76 ± 14.2 | 0.5 | 70 ± 2 | 80 ± 18.6 | 87 ± 18.3 | 94 ± 15.2 | < 0.001** | 0.0001** |
Gender wise comparison of process outcome Measures
Parameters | Control Arm [Mean ± SD] | Intervention Arm [Mean ± SD] | Comparison of Male Participants | Comparison of Female Participants | ||
---|---|---|---|---|---|---|
Final follow up, n = 52 | Final follow up, n = 83 | |||||
M = 17 | F = 35 | M = 26 | F = 57 | CF vs IF (p-values) | CF vs IF (p-values) | |
HbA1c (%)
| 9.7 ± 1.4 | 9.7 ± 1.3 | 7.9 ± 0.7 | 7.6 ± 0.9 | 0.0001** | 0.0001** |
eABG [mg/dL]
| 233.2 ± 39.9 | 231.4 ± 37.7 | 179.2 ± 21.6 | 171.4 ± 27.1 | 0.0001** | 0.0001** |
SBP [mm/Hg]
| 137.1 ± 6.4 | 136.7 ± 7.6 | 125.8 ± 8.3 | 123.1 ± 10.5 | 0.0001** | 0.0001** |
DBP [mm/Hg]
| 88.8 ± 3.8 | 88.7 ± 4.4 | 85.9 ± 4.7 | 87.1 ± 5.7 | 0.077 | 0.148 |
Cholesterol [mg/dL]
| 229.1 ± 78 | 217 ± 36.5 | 152.6 ± 27 | 153.8 ± 25.6 | 0.0001** | 0.0001** |
TG [mg/dL]
| 170.2 ± 47.3 | 173.4 ± 50 | 141.2 ± 24.1 | 143.1 ± 34.7 | 0.283 | 0.0001** |
HDL-C [mg/dL]
| 48.3 ± 12.3 | 49.9 ± 14.8 | 47.8 ± 7.7 | 49.4 ± 8 | 0.210 | 0.170 |
LDL-C [mg/dL]
| 75.6 ± 93.5 | 85.8 ± 67.3 | 76.5 ± 25.2 | 75.7 ± 20.2 | 0.0001** | 0.0001** |
VLDL-C [mg/dL]
| 17 ± 18.5 | 22.3 ± 18.4 | 28.3 ± 4.8 | 28.6 ± 6.9 | 0.284 | 0.0002** |
SCr [mg/dL]
| 0.9 ± 0.1 | 0.9 ± 0.1 | 0.8 ± 0.2 | 0.8 ± 0.1 | 0.0001** | 0.0001** |
Impact on glycemic goals and other targets of diabetes care
Outcome Measures | Control Arm | Intervention Arm | ||||||
---|---|---|---|---|---|---|---|---|
Follow Up | Follow Up | |||||||
B, n = 121 (%) | 1st, n = 121 (%) | 2nd, n = 121 (%) | 3rd, n = 52 (%) | B, n = 123 (%) | 1st, n = 123 (%) | 2nd, n = 105 (%) | 3rd, n = 83 (%) | |
Glycaemic Goals | ||||||||
% of patients achieving goal HbA1c < 7% | a0 | 2 (1.7) | 2 (1.7) | 0 (0) | a0 | 5 (4.1) | 9 (8.6) | 14 (16.9) |
% of patients achieving goal HbA1c < 8% | a0 | 2 (1.7) | 8 (6.6) | 3 (5.8) | a0 | 14 (11.4) | 28 (26.7) | 33 (39.8) |
% of patients achieving goal HbA1c < 9% | 15 (12.4) | 24 (19.8) | 25 (20.7) | 13 (25) | 18 (14.6) | 27 (22) | 39 (37.1) | 29 (34.9) |
% of patients at HbA1c ≥ 9% | 106 (87.6) | 93 (76.9) | 86 (71.1) | 36 (69.2) | 105 (85.4) | 77 (62.6) | 29 (27.6) | 7 (8.4) |
Blood Pressure Goals | ||||||||
% of patients with SBP < 130 mmHg | 42 (34.7) | 41 (33.9) | 27 (22.3) | 4 (7.7) | 22 (17.9) | 31 (25.2) | 39 (37.1) | 45 (54.2) |
% of patients with SBP ≥130 mmHg | 79 (65.3) | 80 (66.1) | 94 (77.7) | 48 (92.3) | 101 (82.1) | 92 (74.8) | 65 (62.9) | 38 (45.8) |
% of patients with SBP ≥140 mmHg | 49 (40.5) | 40 (33.1) | 45 (37.2) | 29 (55.8) | 84 (68.3) | 51 (41.5) | 19 (18.1) | 8 (9.6) |
% of patients with DBP < 80 mmHg | 12 (9.9) | 11 (9.1) | 9 (7.4) | 0 (0) | 3 (2.4) | 2 (1.6) | 2 (1.9) | 1 (1.2) |
% of patients with DBP ≥80 mmHg | 109 (90.1) | 110 (90.9) | 112 (92.6) | 52 (100) | 120 (97.6) | 121 (98.4) | 103 (98.1) | 82 (98.8) |
% of patients with DBP ≥90 mmHg | 56 (46.3) | 72 (59.5) | 76 (62.8) | 43 (82.7) | 97 (78.9) | 89 (72.4) | 69 (65.7) | 48 (57.8) |