10893
document
A randomized trial of continuous subcutaneous insulin infusion and intensive injection therapy in type 1 diabetes for patients with long-standing poor glycemic control . OBJECTIVE To assess in a randomized crossover trial the efficacy of continuous subcutaneous insulin infusion in improving glycemic control and health-related quality of life in type 1 diabetic patients with long-standing poor glycemic control . RESEARCH DESIGN AND METHODS A total of 79 patients in 11 Dutch centers were randomized to 16 weeks of continuous subcutaneous insulin infusion followed by 16 weeks intensive injection therapy or the reverse order . Glycemic control was assessed by HbA ( 1c ) , self-reported hypoglycemic events , and blood glucose memory meter read outs . Changes in quality of life were assessed by self-report questionnaires administered at baseline and 16 weeks . RESULTS As the drop-out rate after crossover was high ( 17 of 79 patients [ 22 % ] ) , we analyzed the trial as a parallel clinical trial , using data of the first half of the crossover phase only . At 16 weeks , mean HbA ( 1c ) was 0.84 % ( 95 % CI -1.31 to -0.36 ) lower in the continuous subcutaneous insulin infusion group compared with the insulin injection group ( P = 0.002 ) . Stability of blood glucose self-measurement values , expressed as SD of the nine-point blood glucose profiles , improved in the insulin pump group by 29.3 +/- 41.1 vs. 8.2 +/- 36.5 % in the injection group ( P = 0.039 ) . The number of mild hypoglycemic episodes per patient-week was 0.99 ( 95 % CI 0.11-1.87 ) higher in the insulin pump group ( P = 0.028 ) . Weight gain was similar in both groups . Scores on the Short-Form 36-Item subscales 'general health ' and 'mental health ' improved in the continuous subcutaneous insulin infusion group , compared with stable values in the injection group ( P = 0.048 and 0.050 , respectively ) . CONCLUSIONS Continuous subcutaneous insulin infusion improves glycemic control and some aspects of health-related quality of life in patients with a history of long-term poor glycemic control .
10894
Intervention_Pharmacological
insulin
10895
Intervention_Pharmacological
continuous subcutaneous insulin infusion
10896
Intervention_Pharmacological
intensive injection therapy
10897
Intervention_Pharmacological
insulin
10898
Intervention_Pharmacological
insulin
10899
Outcome_Physical
glycemic control
10900
Outcome_Other
health-related quality of life
10901
Outcome_Mental
quality of life
10902
Outcome_Physical
mean HbA ( 1c )
10903
Outcome_Physical
Stability of blood glucose self-measurement values
10904
Outcome_Mental
number of mild hypoglycemic episodes
10905
Outcome_Physical
Weight gain
10906
Outcome_Physical
Scores on the Short-Form 36-Item subscales 'general health
10907
Outcome_Other
' and
10908
Outcome_Mental
'mental health
10909
Outcome_Other
'
10910
Participant_Condition
type 1 diabetic
10911
Participant_Condition
poor glycemic control
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Participant_Condition
A total of 79 patients in 11 Dutch centers
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Participant_Condition
poor glycemic control