Paediatric onset study to assess the efficacy of insulin pump therapy using the MiniMed Paradigm® REAL-Time system during the first year of diabetes in children and adolescents with type 1 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN05450731

Enrollment

160

Registered

2008-07-31

Start date

2006-12-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Type 1 diabetes mellitus Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

Patients will be randomised into two groups: Group A: MiniMed Paradigm® REAL-Time insulin pump system with continuous glucose monitoring Group B: MiniMed Paradigm® 515/715 insulin pump with conventio

at the time of registration, the funder was also indicated to be the sponsor.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provided written informed consent 2. Aged between 1 (inclusive) and 17 (exclusive) years (either sex) and diagnosed with type 1 diabetes at latest 4 weeks prior to study entry 3. Patients must be willing to use the MiniMed Paradigm® REAL-Time system or MiniMed Paradigm® 515/715 insulin pump combined to conventional SMBG finger sticks for 12 months 4. Patients must be able and willing to perform at least two SMBG finger sticks daily 5. Patients are willing to undergo all study procedures 6. Training on how to adapt their insulin dose to their meals and awareness of how to calculate and apply corrective insulin boluses as well as of the influence of physical activity and their life style factors on their metabolic control 7. Patients are willing to participate to the MiniMed Paradigm® REAL-Time system (Group A) and to the MiniMed Paradigm® 515/715 plus the Guardian REAL-Time Clinical (Group B)

Exclusion criteria

Exclusion criteria: 1. Hearing or vision impairment so that alarms cannot be recognised 2. Patient does not have reliable support person or is unwilling to comply with the provisions of the protocol 3. Mental incapacity 4. Language barriers precluding adequate understanding or cooperation 5. Patients suffering from severe chronic disease or genetic disorder other than type 1 diabetes (i.e. Down syndrome, etc.) 6. Pregnancy 7. Eating disorders 8. Alcohol or drug abuse other than nicotine 9. Patients participating in other device or drug related studies 10. Patients disclaimer of study participation

Design outcomes

Primary

Measure	Time frame
HbA1c (central determination with HPLC) after 12 months of treatment, measured at baseline, 6 weeks, and 6, 12, 15 and 24 months.	—

Secondary

Measure	Time frame
1. Dose of insulin per day, percentages of basal and bolus insulin dose as calculated from the pump downloads using the CareLink software, measured at 6 weeks and 6, 12, 15 and 24 months 2. Average number of daily boluses as calculated from the pump downloads using the CareLink software, measured at 6 weeks and 6, 12, 15 and 24 months 3. Frequency of sensor use, measured at 6 weeks and 6, 12, 15 and 24 months (group A only) 4. Frequency of daily SMBG measurements, measured at baseline, 6 weeks and 6, 12, 15 and 24 months 5. Stimulated C-peptide, measured at baseline, 12 and 24 months 6. Height and Ht SDS, weight and Wt SDS, BMI and BMI SDS, measured at baseline, 6 weeks and 6, 12, 15 and 24 months 7. Glucose average and variation during 24h as documented by Paradigm REAL-Time and Guardian REAL-Time Clinical (blinded to glucose values) in the control group 8. Occurrence of hypoglycaemia below 70 mg/dl (3.9 mmol/l) during 24 hour expressed as Area under the Curve (AUC) below 70 mg/dl (3.9 mmol/l), measured at 6 weeks and 6, 12, 15 and 24 months 9. Occurrence of hyperglycaemia above 200 mg/dl (11.1 mmol/l) during 24 hours expressed as Area Under the Curve (AUC) above 200 mg/dl (11.1 mmol/l), measured at 6 weeks and 6, 12, 15 and 24 months 10. Serious adverse events (severe hypoglycaemia/DKA), measured at 6 weeks and 6, 12, 15 and 24 months 11. Treatment/device complications reported by patients/parents 12. Patient's QoL outcome (DISABKIDS for children aged 8 - 16 years), measured at -1 day and 6, 12 and 24 months 13. Care giver's QoL outcome (DISABKIDS), measured at -1 day and 6, 12 and 24 months 14. Care giver's psychological well-being (WHO 5 questionnaire), measured at -1 day and 6, 12 and 24 months 15. Socioeconomic burden for families (SBQ), measured at -1 day and 6, 12 and 24 months	—

Measure

Time frame

1. Dose of insulin per day, percentages of basal and bolus insulin dose as calculated from the pump downloads using the CareLink software, measured at 6 weeks and 6, 12, 15 and 24 months 2. Average number of daily boluses as calculated from the pump downloads using the CareLink software, measured at 6 weeks and 6, 12, 15 and 24 months 3. Frequency of sensor use, measured at 6 weeks and 6, 12, 15 and 24 months (group A only) 4. Frequency of daily SMBG measurements, measured at baseline, 6 weeks and 6, 12, 15 and 24 months 5. Stimulated C-peptide, measured at baseline, 12 and 24 months 6. Height and Ht SDS, weight and Wt SDS, BMI and BMI SDS, measured at baseline, 6 weeks and 6, 12, 15 and 24 months 7. Glucose average and variation during 24h as documented by Paradigm REAL-Time and Guardian REAL-Time Clinical (blinded to glucose values) in the control group 8. Occurrence of hypoglycaemia below 70 mg/dl (3.9 mmol/l) during 24 hour expressed as Area under the Curve (AUC) below 70 mg/dl (3.9 mmol/l), measured at 6 weeks and 6, 12, 15 and 24 months 9. Occurrence of hyperglycaemia above 200 mg/dl (11.1 mmol/l) during 24 hours expressed as Area Under the Curve (AUC) above 200 mg/dl (11.1 mmol/l), measured at 6 weeks and 6, 12, 15 and 24 months 10. Serious adverse events (severe hypoglycaemia/DKA), measured at 6 weeks and 6, 12, 15 and 24 months 11. Treatment/device complications reported by patients/parents 12. Patient's QoL outcome (DISABKIDS for children aged 8 - 16 years), measured at -1 day and 6, 12 and 24 months 13. Care giver's QoL outcome (DISABKIDS), measured at -1 day and 6, 12 and 24 months 14. Care giver's psychological well-being (WHO 5 questionnaire), measured at -1 day and 6, 12 and 24 months 15. Socioeconomic burden for families (SBQ), measured at -1 day and 6, 12 and 24 months

—

Countries

Austria, France, Germany, Poland, Sweden, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026