Auteur en jaartal

Redenen van exclusie

Barnard, 2014

Andere vraagstelling

Cemeroglu, 2014

Andere vraagstelling

Hanas, 2014

Alleen abstract

Hommel, 2014

Andere vraagstelling

Wong, 2014

Andere uitkomstmaat

Brorsson, 2013

Studieprotocol

Neylon, 2013

Andere vraagstelling

Norgaard, 2013

Andere vraagstelling

Peyrot, 2012

Andere vraagstelling

Frontino, 2012

Andere vraagstelling

Golden, Sapir, 2012

Dubbel/overlap Golden 2012

Langendam, 2012

Andere vraagstelling

De Vries, 2011

Andere vraagstelling

Jenkins, 2011

Andere vraagstelling

Leelarathna, 2011

Andere vraagstelling en andere populatie (volwassenen).

Felina, 2010

Niet-systematische review

Gane, 2010

Alleen abstract verkrijgbaar

Ingerski, 2010

Andere vraagstelling

Kordonouri, 2010

Andere vraagstelling

Misso, 2010

Kinderen en volwassenen. Geen aparte analyse kinderen

Seereiner, 2010

Andere uitkomstmaat. Opgenomen in overwegingen.

Nabhan, 2009

Andere uitkomstmaat

Paris, 2009

Andere uitkomstmaat

De Wit, 2008

Andere vraagstelling

Nuboer, 2008

Opgenomen in SR van Golden (2012)

Rabbone, 2008

Andere vraagstelling

Skogsberg, 2008

Opgenomen in SR van Golden (2012)

Opipari- Arrigan, 2007

Opgenomen in SR van Golden (2012)

Weissberg-Benchell, 2007

Andere vraagstelling

Kordonouri, 2006

Andere uitkomstmaat

Fox, 2005

Opgenomen in SR van Churchill 2009 en Barnard 2007

Wilson, 2005

Opgenomen in SR van Churchill 2009 en Barnard 2007

DiMeglio, 2004

Opgenomen in SR van Churchill 2009

Mednick, 2004

Opgenomen in SR van Barnard 2007

Shehadeh, 2004

Opgenomen in SR van Churchill 2009

Weinzimer, 2004

Opgenomen in SR van Churchill 2009

Weintrob, 2003

Opgenomen in SR van Golden (2012) en Barnard 2007

Weissberg-Benchell, 2003

Observaties, niet geschikt voor literatuuranalyse

Tsui, 2001

Andere populatie (volwassenen).

Study

First author, year

Appropriate and clearly focused question?¹

Yes/no/unclear

Comprehensive and systematic literature search?²

Yes/no/unclear

Description of included and excluded studies?³

Yes/no/unclear

Description of relevant characteristics of included studies?⁴

Yes/no/unclear

Appropriate adjustment for potential confounders in observational studies?⁵

Yes/no/unclear/notapplicable

Assessment of scientific quality of included studies?⁶

Yes/no/unclear

Enough similarities between studies to make combining them reasonable?⁷

Yes/no/unclear

Potential risk of publication bias taken into account?⁸

Yes/no/unclear

Potential conflicts of interest reported?⁹

Yes/no/unclear

Kinderen

Golden, 2012

Yes

Yes

Yes

Yes

 -

Yes

Yes

No

No

Barnard, 2007

Yes

Yes

No

Yes

No

Yes

Yes

No

No

Ouders

Churchill, 2009

Yes

Yes (limited description of search strategy)

No (only included studies)

Yes

No

Yes

No

No

No

Study reference

(first author, year of publication)

Bias due to a non-representative or ill-defined sample of patients?¹

(unlikely/likely/unclear)

Bias due to insufficiently long, or incomplete follow-up, or differences in follow-up between treatment groups?²

(unlikely/likely/unclear)

Bias due to ill-defined or inadequately measured outcome ?³

(unlikely/likely/unclear)

Bias due to inadequate adjustment for all important prognostic factors?⁴

(unlikely/likely/unclear)

Cogen et al, 2007

unlikely

Likely

Note: incomplete outcome data 6 months follow up (37% is missing)

unlikely

unclear

Pankowska

Unclear (loss to follow up not reported)

unlikely

unclear

Müller-Godeffroy

unlikely

Unlikely

unlikely

unclear

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Kinderen

Golden, 2012

SR and meta-analysis [RCT; sub analyse QoL]

Literature search up to July 2011.

A: Nuboer, 2008

B: Opipari-Arrigan, 2007

C: Doyle 2004

D: Cohen, 2003;

E: Skogsberg, 2008

F: Weintrob, 2003;

Setting and Country:

outpatient setting

A: ?

B: U.S.

C: U.S.

D: Israel

E: Sweden

F: Israel

Source of funding:

A: government support/ other sources of support

B: other sources of support

C: industry support/ government support

D: industry support/ other sources of support

E: industry support/ government support/ other sources of support

F: industry support

Inclusion criteria SR: studies comparing the effects of CSII with MDI among children and

adolescents, with type 1 diabetes.

Exclusion criteria: articles with no original data (reviews, editorials, and commentaries) or studies published in abstract form only; case reports, case series, and cross-sectional studies.

Studies published before 1994,

the 1st year that insulin analogues were used.

Studies in which regular insulin was used in the insulin pump as this is not consistent with current clinical practice.

In total 41 studies (44 publications) included in this reviewà 18 studies evaluated health-related quality of life (QOL) using 15 different validated QOL assessment tools.

A: 38 children and adolescents

(age range 6-16 yr) with type 1 diabetes

B: Sixteen children (age range 3.1–5.3 yrs) with type 1

diabetes

C: 32 children and adolescents with type 1 diabetes (age range 8 –21 yrs)

D: 16 adolescents (range 15-18)

with type 1 diabetes for at least 2 years “and no other chronic

disease which could interfere

with diabetes treatment”

E: 72 children and adolescents (age range 7-17 yrs) with type 1 diabetes

F: 23 children (age range 9 to 13 yrs) with type 1 diabetes for at

least 2 years, and “ability to cope, with the parents, with treatment”

Describe intervention: CSII

Pediatric Quality of Life

Inventory*

A: CSII (n=19)

B: CSII (n=6)

DQOL-Y†

C: CSII (n=16)

D: CSII

DTSQ‡

D: CSII

E: CSII (n=34)

F: CSII

Describe control: MDI

MDI defined as at least three injections per day

Pediatric Quality of Life

Inventory*

A: MDI with MDI run-in period (n=19)

B: MDI (n= 8)

DQOL-Y†

C: MDI (n= 16)

D: MDI

DTSQ‡

D: MDI

E: MDI (n= 38)

F: MDI

End-point of follow-up:

A: 7 months

B: 6 months

C: 16 weeks

D: ?

E: 24 months

F: after 3.5 months of treatment

For how many participants were no complete outcome data available?

(intervention/control)

A: ?

B: ?

C: ?

D: 16 enrolled; 12 completed the study (crossover study)

E: ?

F: 23 children (crossover study)

Outcome measure

quality of life

Difference in QOL Between Comparison and Baseline Groups

Sub analyse QoL:

Pediatric Quality of Life

Inventory*

A: difference from baseline to end of randomization was 2.8 (95% CI, -3.1 to 8.7) in CSII vs. 0.4 (95% CI, -7.4 to 8.2) in MDI

B: difference from baseline to end of experimental phase was 8 (95% CI, -5.6 to 21.6) in CSII vs. 6.5 (95% CI, -16.4 to 29.4) in MDI

DQOL-Y†

C: “There were no differences in DQOL-Y scores between the two groups at baseline or 16

weeks (data not shown)”

D: Data for the individual treatment groups was not given. “The Satisfaction score was 77.4 (95% CI, 69.5 to 85.3) at the beginning of the study, 76.4 (95% CI, 68.3 to 84.5) at the end of the MDI arm, and 82.7 (95% CI, 75.3 to 90.1)

at the end of the CSII arm (P<0.05)”

DTSQ‡

E: 33.1 (95% CI, 32.8 to

33.4) in CSII vs. 27.5 (95% CI, 26.8 to 28.2) in MDI, P<0.001.

D: Total score was 20.5 (95% CI, 18.7 to 22.3) at the beginning of the study, 21.8 (95% CI, 19.7 to 23.9) at the end of the MDI arm (after 6

months), and 32 (95% CI, 28.3 to 35.7) at the end of the CSII arm (after 6 months) (P<0.05)

F: Total score was 21.4 (95% CI, 20.1 to 22.7) at the beginning of the study, 21.9 (95% CI, 19.7 to 24.1) at the end of the MDI arm (after 3.5

months of treatment), and 30.6 (95% CI, 28.4 to 32.8) at the end of the CSII arm (P<0.001).

CSII = continuous subcutaneous insulin infusion;

MDI = multiple daily injections;

*General QOL measure. Total scores from the Pediatric Qualtiy of Life Inventory range from 0 to 100, with higher scores indicating better quality of life.

†Diabetes-specific QOL measure. Total scores from the Diabetes Quality of Life-Youth range from 0 to 100, with higher scores indicating higher satisfaction.

‡Diabetes treatment-related QOL measure. Total scores from the Diabetes Treatment Satisfaction Questionnaire range from 0 to 36, with higher scores indicating higher

satisfaction.

Group Favored for QOL measure

Pediatric Quality of Life

Inventory*

A: CSII

B: CSII

DQOL-Y†

C: Neither

D: CSII

DTSQ‡

D: CSII

E: CSII

F: CSII

The strength of evidence was low comparing CSII with MDI for general QOL. Two

Studies (A and B) used the Pediatric Quality of Life Inventory. A meta-analysis of these studies did not favor CSII or MDI in this population (mean between-group difference, 2.3; 95%

CI, -6.9 to 11.5; P=0.95).

The strength of evidence was low comparing CSII with MDI for diabetes-specific QOL.

Three studies used the Diabetes Treatment Satisfaction Questionnaire and showed improvement in diabetes treatment satisfaction favoring CSII. (E, D and F) A meta-analysis of

two of these studies favored CSII over MDI (mean between-group difference in the

Diabetes Treatment Satisfaction Questionnaire, 5.7; 95% CI, 5.0 to 6.4; P<0.001). One study (D) showed improvement in diabetes-specific QOL favoring CSII (Diabetes Quality of Life-Youth baseline score 77.4 [95% CI, 69.5 to 85.3] and end of study 76.4 [95% CI, 68.3 to 84.5] for MDI and 82.7 [95% CI, 75.3 to 90.1] for CSII). One study (C) did not find a difference in the Diabetes Quality of Life-Youth scores between the two interventions (numerical data not presented).

Barnard, 2007

SR

Literature search up to July 2005.

Databases: MEDLINE, PsychINFO, Cinahl and Embase, Cochrane database, Web of Science and NICE guidelines

Sub-analyse Paediatric/adolescent studies

A: McMahon et al. 2004; prospective study

B: Mednick et al. 2004; pre/post study

C: Litton et al. 2002; pre/post study

D: Boland et al. 1999; Controlled study

E: Wilson et al. 2005; Randomized open crossover trial

F: Weintrob et al. 2003; Randomized open crossover trial

G: Fox et al. 2005; Randomized controlled study

Setting and Country:

NR

A: ?

B: urban children’s hospital

C:

D:

E:

F:

G:

Source of funding:

Roche Diagnostics UK Ltd have provided research funding to K.D.B. and T.C.S. to conduct research into Quality of Life

Issues Surrounding Insulin Pump Use in Type 1 Diabetes.

Inclusion criteria SR: studies reporting on some facet of quality of life in participants with Type 1 diabetes,

regardless of age and gender, good or poor glycaemic

control

Exclusion criteria; NR

In total 8 studies

Gender (% female)

A: 59

B: 54

C: 44

D: 60 CSII/ 56 MDI

E: 63

F: 57

G: -

Age (years)

A: 12,5 ± 3,8

B: 13,59 ± 2,9

C: 13,7 months mean age

D: CSII 13,8 ± 2,1/ MDI 14,6 ± 2,0

E: 3,6 year mean

F: 11,8 ± 1,4

G: 46,3 ± 3,2 months

No. of participants

providing QoL data

A: 43

B: 22

C: 9

D: CSSI 25/ MDI 50

E: CSII 9/ MDI 10

F: 23

G: 22

A: patients started on insulin pump therapy with a view to identifying

improvements in key parameters of diabetes management,

including quality of life

B: children who were transitioning to the insulin

pump, and one of each of their parents took part. Prior to the change, all children had been

treated with intensive diabetes regimens where the average number of blood glucose tests performed each day was four and the average number of insulin injections taken per day was three.

C: analysed the effect of pump therapy in nine

toddlers in whom Type 1 diabetes developed between the ages

of 10 and 40 months. After a mean of 13.7 months of multiple daily injection (MDI) therapy, patients were treated with

insulin pumps for periods ranging from 7 to 19 months (mean

12.7 months).

D: CSII

E: CSII

F: CSII

G CSII

A: - (pre-post)

B: - (pre-post)

C: -

D: MDI

E: MDI

F: MDI

G: : current therapy

End-point of follow-up:

A: ?

B: ?

C: 7 to 19 months (mean

12.7 months)

D: 12-month

E: 28 weeks and 52 weeks

F: 8 month

G: After 6 months, current therapy participants were

offered CSII

For how many participants were no complete outcome data available?

(intervention/control)

A: 42 (all)

B: ?

C: ?

D: ?

E: ?

F: ?

G: all

A: Components of quality

of life measures showed improvements on pump treatment. There were no significant differences in ‘worries about diabetes’

and ‘satisfaction with life’ did not change. Scores of individuals’ self-efficacy with diabetes (as well as those of their parents) increased significantly (P<0.05) and scores for impact of diabetes on the participants fell, indicating decreased impact.

B: children and parents were overwhelmingly satisfied with insulin pump use, with both children and parents reporting greatest satisfaction with flexibility relating to eating and sleeping afforded by pump therapy.

Parent–child satisfaction were highly correlated (r = 0.53) and children’s pump satisfaction was significantly positively correlated with diabetes-related quality of life (r = 0.51).

DQOLY: indicated perceived quality of life improvements following pump start-up, mainly due to greater flexibility with leisure-time

activities and with diets.

C: Subjective assessments (not identified) revealed

significant improvements in quality of life and high levels

of satisfaction with pump therapy, although no evidence was provided to support this statement.

D: Self-report questionnaires, i.e. DQOLY, demonstrated that there was improvement in self-efficacy, depression and quality of life in both MDI- and CSII-treated participants. There were no statistically significant differences between groups. Adolescents using CSII reportedly found coping with diabetes to be less difficult than adolescents using MDI.

E: there was no difference between the groups in quality of life when measured using the DQOL, designed for parents of toddlers with diabetes. Although the improvement in the CSII group, from baseline to the end of the study, was significant (P = 0.03), the difference between the two groups, CSII vs. MDI, was not.

F: participants expressed higher treatment satisfaction

with CSII than with MDI, and a significant difference between treatment groups in patient satisfaction on the DTSQ measure was recorded (P < 0.001). There was no significant difference

between groups for the DQOLY measure, indicating no difference in quality of life between the two modes.

G: There were no differences in parental quality of life,

as measured by DQOL and Parent Rated Quality Of Life

(PDQOL) between groups at baseline or after 6 months

A: DQOL—impact of diabetes, DQOL—worries about diabetes,

DQOL—satisfaction with life, Self Efficacy for Diabetes scale

B: DQOLY

C: Subjective

D: DQOLY [36]—depression, worry, satisfaction, impact

(all 6 month/12 month)

E: DQOL

F: DTSQ, DQOLY—satisfaction, DQOLY—impact, DQOLY—worry

G: PDQOL, BSI, PSI

Ouders

Churchill, 2009

SR

Literature search up to March 2008.

A: Litton et al. (2002)

B: DiMeglio et al. (2004); RCT

C: Shehadeh et al. (2004)

D: Weinzimer et al. (2004)

E: Fox et al. (2005); RCT

F: Jeha et al. (2005)

G: Wilson et al. (2005); RCT

Setting and Country: NR

Source of funding: NR

Inclusion criteria SR:

-children

with type 1 diabetes 6 years of age and younger,

-RCTs or quasi-experimental

research design, and outcome measures of HbA1c and episodes of hypoglycemia.

Although not our

primary objective, we also were interested in the criteria used in each study to define hypoglycemia as

well as quality of life (QOL) measures.

Exclusion criteria:

NR

In total 7 studies included in this reviewà 3 Randomized controlled trials

4 Quasi-experimental studies

Sample size:

A: 9

B: 37

C: 14

D: 65

E: 22

F: 10

G: 19

Average age in the studies range from 1 to 6,4 years

Duration of type 1 diabetes Form 6 mo to 2 years

insulin pump therapy

insulin injection therapy (3 or more injections per day using long-acting and short acting insulin analogs)

Length of follow-up after initiation of CSII ranged from 6 mo to 4 years

Study duration

A: 12 mo

B: 6 mo

C: 12 mo

D: 12 mo (6 subjects followed 12 mo)

E: 6 mo

F: 6 mo

G: 12 mo

withdrawal or loss tot follow-up (control/ intervention)

B: 4/1

Reason: one withdrew prior to the baseline visit, one dropped

out because of insufficient

compliance with protocol, two

withdrew because of divorce, and one subject in the pump group could not continue because of a tape allergy.

E: 2/2

Reason: Two subjects

dropped out of the injection

group—one who preferred pump therapy withdrew after randomization to the injection group, and one was lost to follow-up. Two subjects

in the pump group withdrew after randomization because the children refused to wear the pump.

C: 1

Reason: did not explain

the withdrawal of one subject.

G: 1/2 and two subjects

prior to randomization.

Reason: one injection subject

moved, a CSII subject had a delay in receiving the pump, and another CSII subject was lost to follow-up.

Of the 19 remaining

subjects, two did not complete

a full year of study, but their data were retained and an intent to treat

analysis was performed

In all studies, the percentage

lost to follow up was less than 20%, with the highest in the study by DeMeglio et al. (B) at 19%.

Outcome measure

quality of life

Parental QOL

C and G: using DQOL (Diabetes Quality of Life scale) based on questionnaire used in the DCCT

F: using Parenting Stress Index

E: using several validated questionnaires to assess parental QOL: Brief Symptom Inventory; Impact on Family Scale; Parental Stress Index and the Pediatric Diabetes Quality of Life Scale.

D: based on report of parental satisfaction and desire to continue pump use after study completion.

(C, G and E: different modified versions of the DQOL survey)

CSII was associated with improved parental QOL, particularly with fathers.

C: at baseline and after 4 months of therapy. The results showed significant improvements in DQOL following insulin pump therapy.

G: at baseline, 28 weeks, and 52 weeks.

Significant improvement in DQOL in the CSII group from baseline to the end of the study (P =.03).

E: significant increase in QOL scores in the CSII group for fathers at 6 months from

baseline. Mothers assigned to CSII also reported an increase in QOL when compared with mothers

in the injection group.

D: Mothers reported that CSII ‘‘gave them their life back’’ and enabled them to return to work outside the home. This response suggests potential

improvement in QOL for

CSII users and their families

The remaining studies

did not directly assess parental QOL. However, the fact that nearly all participating families chose to switch to or continue CSII after having participated in the study is an indicator of parent satisfaction.

Study description:

A: Compared HbA1c and episodes of hypoglycemia in young children before and after initiation of CSII

B: Compared HbA1c, safety,

episodes of hypoglycemia,

and parental satisfaction

in young children on $2 injections/day to CSII

C: Multi-center, compared

HbA1c, episodes of hypoglycemia and QOL in young children before and after CSII initiation

D: Compared HbA1c, episodes

of hypoglycemia, and parental

satisfaction in young

children before and after CSII initiation; sub analysis of children cared for by paid caretakers

E: Compared HbA1c, blood

glucose, episodes

of hypoglycemia, and QOL in young children on 2-3 injections/day

with CSII

F: Compared HbA1c, blood

glucose, episodes of hypoglycemia, and parental

stress in young children before and after CSII initiation

G: Multi-center, compared

HbA1c, episodes of hypoglycemia, and QOL in young children on 2-3 injections/day with CSII

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Kinderen

Cogen, 2007

Type of study: before – after study experimental design

Setting: hospital/ home

Country: USA

Source of funding: NR

Inclusion criteria:

Children planning on transitioning to CSII

Exclusion criteria:

NR

N total at baseline: 52

Important prognostic factors²:

Mean age: 12,8 year

white race/ethnicity: 46/ 52 (89%);

children’s parents were married: 45/ 52 (87%)

Before CSII:

having DM for a mean of 3.9 years, mean hemoglobin A1c level: 7,4%, using a basal bolus regimen: 26/52,

using neutral protamine Hagedorn/

regular with 3 daily injections; 26/52

CSII

Conventional or glargine type 1 DM therapy regimen

Length of follow-up:

3 months prior

1 month and 6 month following their transition

Incomplete outcome data:

1 month

N= 0 (0%)

6 months

N= 14 (37%)

Reasons: NR

short-term and long-term

changes in children’s quality of life

Quality of life (mean ± SD)

Baseline

Conventional: 37.2 ± 14.1^bc

Glargine: 28.3 ± 7.9

1 mo

Conventional: 29.7 ± 9.1^b

Glargine: 28.1 ± 8.3

6 mo

Conventional: 30.8 ± 11.7^c Glargine: 27.0 ± 9.1

Means with identical superscripts differ statistically significantly at P <.05.

Diabetes Quality of Life Scale for Youth, a 53-item questionnaire asking children to rate how satisfied they are with various aspects of

their diabetes regimen.

Müller-Godeffroy, 2009

Type of study: multi-centre prospective observational pre- ⁄ post-study

Inclusion criteria:

children

and adolescents with Type 1 DM aged 4 to 16 years, and their

main carer

Exclusion criteria:

diabetes < 6 months, learning disabilities and

insufficient German literacy to answer questionnaires

N total at baseline:

4–7 y: n=29;

8–11 y n=38;

12–16 y: n=76.

108 parents 8-16 y

N at 6 months:

53 girls, 64 boys

age 10.5 ± 3.7 years

4–7 y: n=29;

8–11 y n=25;

12–16 y: n=63.

85 parents 8-16 y.

CSII

The patients were transfered from multiple daily insulin injection therapy (MDI) to CSII by an interdisciplinary diabetes team following the guidelines of the German Working Group

for CSII Therapy in Children and Adolescents. To ensure comparability, the cooperating institutions participated in a training curriculum developed by the study centre. For change of therapy, the children were admitted to hospital for 3–7 days.

MDI

Length of follow-up:

6 months

Incomplete outcome data:

Loss to follow-up 8-16 y:

23% children, 18% parents

Three children withdrew from pump therapy

during the observational period because of the inconvenience of

wearing the pump.

Outcome measures:

CHILDREN

Health-related quality of life (HRQOL):

4-7y:

KINDL-R (1-100)

Baseline 75.1 ± 9.75

Mean difference 3.82 (-0.27-7.92), p=0.066

KINDL-DM (1-100)

Baseline 62.3 ± 11.74

Mean difference 17.61 (10.36-24.85), p=0.0001

8-11y:

KIDSCREEN-Index (1-100)

Baseline 78.8 ± 12.67

Mean difference 2.14 (-2.51–6.79), p=0.348

KINDL-DM (1-100)

Baseline 64.2 ± 15.09

Mean difference 13.16 (7.35-18.98), p=0.0001

12-16y:

KIDSCREEN-Index (1-100)

Baseline 79.4 ± 12.08

Mean difference 0.07 (-3.13–3.28), p=0.964

KINDL-DM (1-100)

Baseline 69.6 ± 11.74

Mean difference 6.68 (3.68-9.68), p=0.0001.

The aim of this pilot study was to investigate different

psychosocial features which might be relevant for patients and parents using CSII therapy and to identify appropriate sensitive

measures before undertaking an expensive large-scale randomized controlled trial.

Ouders

Pankowska, 2010

Type of study: QRCT

Setting: home

Country: Poland

Source of funding:

The study was funded by NovoNordisk A=S, Copenhagen,

Denmark.

Inclusion criteria:

A1C<12%,

Exclusion criteria:

?

N total at baseline: 61

Intervention: 20

Control: 20 (IAsp MDI)

21 (HI MDI)

Important prognostic factors²:

Age (years)

IAsp CSII: 5.7 (3.3–7.0)

IAsp MDI: 5.2 (2.0–6.8)

HI MDI: 5.4 (2.8–6.9)

Weight (kg)

IAsp CSII: 21.1 (17.0–26.0)

IAsp MDI: 20.1 (13.0–26.0)

HI MDI: 21.5 (13.0–32.0)

A1C (%)

IAsp CSII: 7.7 (6.3–9.1)

IAsp MDI: 7.4 (5.6–8.6)

HI MDI: 7.5 (5.2–9.6)

Duration of Diagnosed diabetes (months)

IAsp CSII: 30.2 (11.5–68.2)

IAsp MDI: 23.2 (11.6–45.3)

HI MDI:24.0 (12.2–58.7)

Exposure to trial drug (days)

IAsp CSII: 208 (194–234)

IAsp MDI: 195 (47–219)

HI MDI: 208 (199–219)

Data are mean values with ranges in parentheses

Groups comparable at baseline? no significant difference among the groups

IAsp CSII

IAsp MDI

HI MDI

Length of follow-up:

Treatment continued for 26 weeks

Loss-to-follow-up:

Not registered

Incomplete outcome data:

Not registered

Treatment satisfaction total score

for mean change in score during treatment (SD)
IAsp CSII: 5.1,

IAsp MDI: 5.6,

HI MDI: 4.4.

Subscores satisfaction

with the frequency of:

- hypoglycaemia

Median (SD) score at

Randomization

IAsp CSII: 3,2 (1,4)

IAsp MDI: 4,1 (1,0)

HI MDI: 3,7 (1,3)

Trial end point

IAsp CSII: 4,1 (1,2)

IAsp MDI: 3,1 (1,1)

HI MDI: 3,2 (1,1)

Mean (SD) change

from randomization

to trial end point

IAsp CSII: 0,9 (1,2)

IAsp MDI: -1,1 (1,3)

HI MDI: -0,6 (1,4)

P=0.0002 for changes between treatment groups using the Kruskal-Wallis test.

- hyperglycaemia

NR

Treatment satisfaction was evaluated by the parent/

caretaker at the beginning and end of active treatment using a validated and translated questionnaire based on the WHO Diabetes Treatment Satisfaction Questionnaire (DTSQ), with modifications that included changing the wording to address the caregivers of patients with diabetes rather than patients themselves.

Children were allocated open-label to IAsp CSII or randomized 1:1 to IAsp MDI or continued HI MDI.

Allocation to the CSII group was based on the choice made by the parent/ caregiver following extensive explanation of the benefits and risks of CSII and MDI. All parents were given the same information, and all had equal opportunity to choose CSII if desired, irrespective of economic/social status.

Müller-Godeffroy, 2009

Type of study: multi-centre prospective observational pre- ⁄ post-study

The aim of this pilot study was to investigate different

psychosocial features which might be relevant for patients and parents using CSII therapy and to identify appropriate sensitive

measures before undertaking an expensive large-scale randomized controlled trial.

Inclusion criteria:

children

and adolescents with Type 1 DM aged 4 to 16 years, and their

main carer

Exclusion criteria:

diabetes < 6 months, learning disabilities and

insufficient German literacy to answer questionnaires

N total at baseline:

4–7 y: n=29;

8–11 y n=38;

12–16 y: n=76.

108 parents 8-16 y

N at 6 months:

53 girls, 64 boys

age 10.5 ± 3.7 years

4–7 y: n=29;

8–11 y n=25;

12–16 y: n=63.

85 parents 8-16 y.

CSII

The patients were transfered from multiple daily insulin injection therapy (MDI) to CSII by an interdisciplinary diabetes team following the guidelines of the German Working Group

for CSII Therapy in Children and Adolescents. To ensure comparability, the cooperating institutions participated in a training curriculum developed by the study centre. For change of therapy, the children were admitted to hospital for 3–7 days.

MDI

Length of follow-up:

6 months

Incomplete outcome data:

Loss to follow-up 8-16 y:

23% children, 18% parents

Three children withdrew from pump therapy

during the observational period because of the inconvenience of

wearing the pump.

Outcome measures:

PARENTS:

4-7y (parents):

Family burden

Paediatric Inventory for Parents (PIP) Total score:

Frequency (42-210)

Baseline 108.2 ± 19.86

Mean difference -4.72 (-22.20 to -7.24) p= 0.0001

Difficulty (42-210)

Baseline 99.2 ± 21.07

Mean difference -1.83 (-19.76 to -3.90) p= 0.005

Hypoglycaemia Fear Survey

Behaviour (10–50)

Baseline 29.1 ± 5.32

Mean difference 1.42 (-1.46 to 4.30) p=0.319

Worry (15–75)

Baseline 42.2 ± 9.31

Mean difference -7.69 (-11.49 to -3.90) p=0.0001

Behavioural Paediatric Feeding Assessment Scale,

Inappropriate Parental Response

Frequency (10–50)

Baseline 20.7 ± 5.08

Mean difference -5.61 (-7.64 to -3.58) p= 0.001

Problem (0–10)

Baseline 2.1 ± 2.06

Mean difference -1.48 (-2.62 to 0.34) p=0.014

8-11 y (parents)

Paediatric Inventory for Parents (PIP) Total score:

Frequency (42-210)

Baseline 101.7 ± 23.21

Mean difference -9.14 (-14.62 to -3.65) p= 0.002

Difficulty (42-210)

Baseline 93.3 ± 28.91

Mean difference -10.03 (-16.41 to -3.66) p= 0.003

Hypoglycaemia Fear Survey

Behaviour (10–50)

Baseline 31.31 ± 7.44

Mean difference -4.11 (-6.15 to -2.07) p=0.0001

Worry (15–75)

Baseline 42.5 ± 12.91

Mean difference -6.52 (-10.03 to -3.00) p=0.001

12-16 y (parents)

Paediatric Inventory for Parents (PIP) Total score:

Frequency (42-210)

Baseline 87.2 ± 18.83

Mean difference -8.21 (-13.25 to -3.18) p= 0.002

Difficulty (42-210)

Baseline 78.8 ± 22.21

Mean difference -6.73 (-11.18 to -2.29) p= 0.004

Hypoglycaemia Fear Survey

Behaviour (10–50)

Baseline 26.2 ± 5.95

Mean difference -1.81 (-3.32 to -0.30) p=0.019

Worry (15–75)

Baseline 37.4 ± 10.11

Mean difference -3.84 (-6.16 to -1.51) p=0.002