Continuous subcutaneous insulin infusion

StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Schiffrin et al, 198412224 young people and young adults with type 1 diabetes (20 analysed)
Aged 13–20 years
Canada
CSII and short-acting insulin (n = 20)
versus
multiple daily injections with short-acting insulin (n = 20)
versus
CSII and multiple daily injections, CSII overnight with preprandial injections of short-acting insulin during the day, pumps used for pre-breakfast bolus (n = 20)
Trial length: three 4-months periods
  1. HbA1 (after 4 months)
  2. Frequency of severe hypoglycaemia
  3. Patient preference
  4. ‘Would you recommend regimen to a friend?’
  5. Insulin dosage
  1. 8.8% vs. 9.6% vs. 9.3% (numbers from NICE TA,121 no confidence intervals given)
    CSII treatment HbA1c level significantly lower than other treatment arm, p < 0.05
  2. 1 vs. 1 vs. 0 episodes
  3. 11 vs. 4 vs. 3 episodes
  4. 100% vs. 66% vs. 70%
  5. 44 (SD 12) vs. 60 (SD 16) vs. 48 units/day (SD 16), p < 0.001
4 patients dropped out of study
Discussed in NICE TA121
Patients ‘failed’ to respond to a twice-daily injections with home blood glucose monitoring regimen, had not previously been on intensive therapy, were not significantly obese
Crossover RCTIb
Schiffrin et al, 198312420 young people and young adults with type 1 diabetes (19 analysed)
Aged 13–18 years, mean age 15 years
Canada
CSII and short-acting insulin (n = 19)
versus
intensive therapy with 3 or 4 daily injections of insulin (n = 19)
Trial length: two 4-month periods
HbA1 (after 4 months)Not significant (numbers not given)1 patient dropped out of study
Patients ‘failed’ to respond to a twice-daily injections regimen
Crossover RCTIb
Cohen et al, 200312616 young people with type 1 diabetes (12 patients analysed)
Aged 14.5–17.9 years, median age 14.2 years
Israel
CSII (n = 12)
versus
multiple daily insulin injections with three or 4 daily injections (n = 12)
Trial length: two 6-month periods
  1. Fructosamine
  2. Frequency of symptomatic hypoglycaemia
  3. Frequency of hyperglycaemic events
  4. Frequency of diabetic ketoacidosis
  5. Body mass index standard deviation score
  6. Treatment satisfaction (can range from 6 to 36, the higher the more satisfied)
  7. Quality of life
  1. 8.15 ± 1.3% vs. 8.57 ± 0.44% (NS)
  2. 384 ± 77 vs. 399 ± 55 nmol/l (NS)
  3. 0.13 vs. 0.61 rate per patient year (NS)
  4. 0.58 ± 1.7 vs. 0.2 ± 0.4 mean per patient per study period (NS)
  5. 1 vs. 0 episodes
  6. 0.23 ± 0.45 vs. 0.25 ± 0.44 (NS)
  7. 32 ± 6.5 vs. 21.8 ± 3.7, p < 0.05
  8. Satisfaction scale: 82.7 ± 13 vs. 76.4 ± 14.3, p < 0.05
4 patients dropped out of studyCrossover RCTIb
Pozzilli et al, 200312723 young people and adults with type 1 diabetes
Aged 12–35 years
Italy
CSII and nicotinamide (n = 19)
versus
intensive subcutaneous therapy and nicotinamide (n = 19)
Trial length: 2 years
  1. HbA1c at 2 years
  2. Frequency of severe hypoglycaemia events
  3. Body weight
  1. 6.3 ± 0.5% vs. 6.2 ± 0.3% (NS)
  2. No differences observed (numbers not given)
  3. No differences observed (numbers not given)
4 patients dropped out of studyRCTIb
Davies et al, 198412513 children and young people with type 1 diabetes
Aged 8–16 years
UK
CSII (n = 13)
versus
intensified conventional treatment (n = 13)
Trial length: 12 months
  1. Mean glycated haemoglobin over the whole treatment period
  2. Moderate or severe hypoglycaemia
  3. Episodes of diabetic ketoacidosis
  1. Mean 9.1% SD 0.9% vs. 10.4% SD 0.2%, p < 0.001
  2. 7 vs. 4 episodes (NS)
  3. 6 vs. 0 episodes
5 patients dropped out of studyRCTIb
Kaufman et al, 200013210 children with type 1 diabetes
Aged 7–10 years
USA
Night time only CSII combined with pre-breakfast injection of intermediate-acting insulin and rapid-acting insulin (n = 10)
versus
3 injections per day of insulin (n = 10)
Trial length: two periods of 4 weeks with 2 weeks in between optimisation/wash-out
  1. Fructosamine
  2. % of blood glucose levels in target
  1. 345 ± 36.6 vs. 390 ± 36.6 μmol/l, p = 0.03
  2. 44 ± 6.7% vs. 37 ± 6.7%, p = 0.04
Crossover RCTIb
Weintrob et al, 200312923 children and young people with type 1 diabetes
Aged 9.4–13.9 years
Israel
CSII (n = 23)
versus
multiple daily injections (n = 23)
Trial length: two periods of 3.5 months
  1. Fructosamine
  2. Frequency of symptomatic hypoglycaemia
  3. Frequency of hyperglycaemic events
  4. Frequency of diabetic ketoacidosis
  5. Body mass index standard deviation score
  6. Treatment satisfaction (can range from 6 to 36, the higher the more satisfied)
  7. Quality of life
  1. 8.0 ± 0.7% vs. 8.1 ± 0.8%, p = 0.03
  2. 362 ± 43 vs. 354 ± 56 μnmol/l (NS)
  3. 0.13 (95% CI 0.0–0.4) vs. 0.36 rate per patient year (95% CI 0.0–0.84) (NS)
  4. 7.9 ± 7 vs. 6.7 ± 7.3 (NS)
  5. 0 vs. 0 episodes
  6. 0.35 ± 0.83 vs. 0.37 ± 0.85, p = 0.012
  7. 30.6 ± 3.7 vs. 21.9 ± 3.8, p < 0.001
  8. Satisfaction scale: 74.8 ± 13.5 vs. 73.5 ± 14.0 (NS)
    Impact scale: 73.2 ± 9.6 vs. 73.5 ± 9.7 (NS)
    Worry scale: 81.6 ± 12.4 vs. 79.8 ± 12.8 (NS)
Crossover RCTIb
Willi et al, 200313051 children and young people with type 1 diabetes
Aged 1.2–15.5 years, mean age 10.7 ± 3.1 years
USA
Followed 12 months before and after introducing CSIIHbA1c12 months before CSII 8.4 ± 0.2% vs. 12 months after transfer to CSII 7.9 ± 0.1%, p < 0.01No strict selection criteria for studyCase seriesIII
Litton et al, 20021319 infants with type 1 diabetes
Aged 20–58 months, mean age 34.1 ± 4.5 months
USA
Children were transferred to CSII after a mean of 13.7 months on multiple daily injections
Children followed for a mean of 12.7 months (range 7–19 months)
  1. Episodes of hypoglycaemia
  1. Before CSII treatment mean 9.5 ± 0.4% vs. after initiation of pump therapy 7.9 ± 0.3%
  2. Before CSII treatment mean 0.52 episodes per month vs. after initiation of pump therapy 0.09 episodes per month
Case seriesIII

From: Evidence tables

Cover of Type 1 Diabetes
Type 1 Diabetes: Diagnosis and Management of Type 1 Diabetes in Children and Young People.
NICE Clinical Guidelines, No. 15.2.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2004 Sep.
Copyright © 2004, National Collaborating Centre for Women’s and Children’s Health.

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