A randomised controlled study of continuous subcutaneous insulin infusion (CSII) therapy compared to conventional bolus insulin treatment in preschool aged children with Type 1 diabetes. - n/a

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004526-72-GB

Enrollment

Registered

2006-02-06

Start date

2006-03-02

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Interventions

Trade Name: Medtronic MiniMed 508, 511 & 512/712 insulin infusion pump Product Name: Insulin infusion pump Product Code: n/a Pharmaceutical Form: Inject

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria i. Newly diagnosed Type 1 diabetes mellitus ii. Age at diagnosis =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: i. Neurological disability / handicap e.g. Cerebral palsy ii. Gastrointestinal disease iii. Chronic illness other than T1DM that may affect conduct of study

Design outcomes

Primary

Measure	Time frame
Main Objective: AIMS OF THE STUDY. The principal aims of this study are to establish whether treatment with continuous subcutaneous insulin infusion (CSII) therapy has advantages over conventional bolus subcutaneous insulin injection treatment regimens in terms of 1. achieving better glycaemic control 2. reducing hypoglycaemia risk 3. preserving endogenous insulin secretion 4. providing a better quality of life for parents and families. PRIMARY OBJECTIVES. The objectives will be to determine whether compared to conventional treatment CSII therapy results in : 1. Improved glycaemic control - as determined by HbA1c index values 2. Reduced frequency of hypoglycaemia - both daytime and nocturnal 3. Better psychological outcome and adjustment to diagnosis and treatment - as determined in the parents and siblings of patients ; Secondary Objective: SECONDARY OBJECTIVES. 1. To determine whether CSII therapy results in longer preservation of endogenous insulin secretion compared to conventional insulin treatment - as evidenced by fasting plasma C-peptide production and lower daily insulin requirements (units/kg/day) assessed at 6 monthly intervals until 2 years after onset of treatment. ; Primary end point(s): OUTCOME MEASURES i. Glycaemic control. The glycated haemoglobin index (HbA1c) will be measured at each local diabetes clinic at 8 to 12 week intervals from diagnosis as per routine clinical care. A central (Addenbrooke's hospital) measurement of HbA1c will be performed on all children at 0, 3, 6, 12, 18 and 24 months. ii. Hypoglycaemia frequency. a). Home blood glucose monitoring data. Families will be supplied with a standard home blood gluco	—

Measure

Time frame

Main Objective: AIMS OF THE STUDY. The principal aims of this study are to establish whether treatment with continuous subcutaneous insulin infusion (CSII) therapy has advantages over conventional bolus subcutaneous insulin injection treatment regimens in terms of 1. achieving better glycaemic control 2. reducing hypoglycaemia risk 3. preserving endogenous insulin secretion 4. providing a better quality of life for parents and families. PRIMARY OBJECTIVES. The objectives will be to determine whether compared to conventional treatment CSII therapy results in : 1. Improved glycaemic control - as determined by HbA1c index values 2. Reduced frequency of hypoglycaemia - both daytime and nocturnal 3. Better psychological outcome and adjustment to diagnosis and treatment - as determined in the parents and siblings of patients ; Secondary Objective: SECONDARY OBJECTIVES. 1. To determine whether CSII therapy results in longer preservation of endogenous insulin secretion compared to conventional insulin treatment - as evidenced by fasting plasma C-peptide production and lower daily insulin requirements (units/kg/day) assessed at 6 monthly intervals until 2 years after onset of treatment. ; Primary end point(s): OUTCOME MEASURES i. Glycaemic control. The glycated haemoglobin index (HbA1c) will be measured at each local diabetes clinic at 8 to 12 week intervals from diagnosis as per routine clinical care. A central (Addenbrooke's hospital) measurement of HbA1c will be performed on all children at 0, 3, 6, 12, 18 and 24 months. ii. Hypoglycaemia frequency. a). Home blood glucose monitoring data. Families will be supplied with a standard home blood gluco

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026