Summary
Background
Many patients with advanced type 2 diabetes do not meet their glycated haemoglobin
targets and randomised controlled studies comparing the efficacy of pump treatment
and multiple daily injections for lowering glucose in insulin-treated patients have
yielded inconclusive results. We aimed to resolve this uncertainty with a randomised
controlled trial (OpT2mise).
Methods
We did this multicentre, controlled trial at 36 hospitals, tertiary care centres,
and referal centres in Canada, Europe, Israel, South Africa, and the USA. Patients
with type 2 diabetes who had poor glycaemic control despite multiple daily injections
with insulin analogues were enrolled into a 2-month dose-optimisation run-in period.
After the run-in period, patients with glycated haemoglobin of 8·0–12·0% (64–108 mmol/mol)
were randomly assigned (1:1) by a computer-generated randomisation sequence (block
size 2 with probability 0·75 and size 4 with probability 0·25) to pump treatment or
to continue with multiple daily injections. Neither patients nor investigators were
masked to treatment allocation. The primary endpoint was change in mean glycated haemoglobin
between baseline and end of the randomised phase for the intention-to-treat population.
This study is registered with ClinicalTrials.gov, number NCT01182493.
Findings
495 of 590 screened patients entered the run-in phase and 331 were randomised (168
to pump treatment, 163 to multiple daily injections). Mean glycated haemoglobin at
baseline was 9% (75 mmol/mol) in both groups. At 6 months, mean glycated haemoglobin
had decreased by 1·1% (SD 1·2; 12 mmol/mol, SD 13) in the pump treatment group and
0·4% (SD 1·1; 4 mmol/mol, SD 12) in the multiple daily injection group, resulting
in a between-group treatment difference of −0·7% (95% CI −0·9 to −0·4; −8 mmol/mol,
95% CI −10 to −4, p<0·0001). At the end of the study, the mean total daily insulin
dose was 97 units (SD 56) with pump treatment versus 122 units (SD 68) for multiple
daily injections (p<0·0001), with no significant difference in bodyweight change between
the two groups (1·5 kg [SD 3·5] vs 1·1 kg [3·6], p=0·322). Two diabetes-related serious adverse events (hyperglycaemia
or ketosis without acidosis) resulting in hospital admission occurred in the pump
treatment group compared with one in the multiple daily injection group. No ketoacidosis
occurred in either group and one episode of severe hypoglycaemia occurred in the multiple
daily injection group.
Interpretation
In patients with poorly controlled type 2 diabetes despite using multiple daily injections
of insulin, pump treatment can be considered as a safe and valuable treatment option.
Funding
Medtronic.
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Article Info
Publication History
Published: July 02, 2014
Identification
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© 2014 Elsevier Ltd. All rights reserved.
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- Continuous subcutaneous insulin infusion for type 2 diabetes
- With the dual onslaught of progressive β-cell failure and insulin resistance, many patients with diabetes struggle to achieve adequate glucose control despite escalation of treatment, including insulin.1 More than a third of patients who start basal insulin need more than 60 units per day to achieve target control2 but, at these doses, insulin absorption is slow and bioavailability is reduced.3 As endogenous insulin production decreases, the risk of hypoglycaemia increases,4 compounding difficulties in achieving glycaemic targets.
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