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Table 2 Feasibility outcomes

From: Glibenclamide and metfoRmin versus stAndard care in gEstational diabeteS (GRACES): a feasibility open label randomised trial

  

Intervention (Glibenclamide) (n = 13)

Standard (Insulin) (n = 10)

Total (n = 23)(95% CI)

Primary outcome: Number of women who agreed to be randomised

 Overall monthly recruitment rate (15.8 months) a

Mean {SD}

  

1.45

{1.21}

  

(0.92 to 2.18)

 Recruitment rate per centre per month (58.9 months) b

Mean {SD}

  

0.39

{0.62}

  

(0.25 to 0.59)

Uptake rate

 Total number of women eligible

n

  

25

 Proportion of those eligiblec agreeing to be randomised

n (%)

    

23

(92.0)

    

(74.0% to 99.0%)

Retentiond

 Number of women who remained in the study

n (%)

13

(100.0)

10

(100.0)

23

(100.0)

(85.2% to 100.0%)

Adherence - Adhered to the treatment regimene

n (%)

9f

(69.2)

   
 

(95% CI)

(38.6% to 90.9%)

   

Safetyg

 Number of women with hypoglycaemic episodes needing treatment

n (%)

0 (0.0)

0 (0.0)

0 (0.0)

 Number of women with SUSARs

n (%)

0 (0.0)

0 (0.0)

0 (0.0)

 Number of women with SAEs

n (%)

2 (15.4)

2 (20.0)

4 (17.4)

 Number of women with other adverse events

n(%)

0 (0.0)

0 (0.0)

0 (0.0)

  1. a Numerator is the number of women randomised, denominator is the total length the trial was recruiting (15.8 months)
  2. b Numerator is the number of women randomised, denominator is the sum of the length of time each centre was open (58.9 months)
  3. c Eligible women defined as those who were recruited or declined to participate but were known to be clinically eligible
  4. d Proportion of women who delivered and remained in the study to provide outcomes
  5. e Glibenclamide allocation only – indicates women who did not switch from Glibenclamide to insulin to maintain normoglycaemia
  6. f 4 switched for the following reasons:
  7. 2 because blood glucose measurements were high
  8. 1 not achieving adequate glycaemic control on insulin. Fasting sugars high but occasional low sugars at lunch
  9. 1 sugars too low with Glibenclamide, but too high without
  10. g As per ITT, provided that they received at least one dose of the treatment allocated