Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/07/2008
Date assigned
31/07/2008
Last edited
02/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Danne

ORCID ID

Contact details

Kinderkrankenhaus auf der Bult
Janusz-Korczak-Allee 12
Hannover
30173
Germany
+49 (0)511 8115 3330
danne@hka.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MHH 4432

Study information

Scientific title

Acronym

ONSET

Study hypothesis

Paediatric patients using the MiniMed Paradigm® REAL-Time system providing a combination of insulin pump and REAL-Time continuous glucose monitoring from the onset of type 1 diabetes have a better glycaemic control after 12 months of type 1 diabetes compared to those using the MiniMed Paradigm® insulin pump combined to conventional self-monitoring blood glucose (SMBG) finger-sticks.

Ethics approval

Ethics approval received from the Ethics Committee of the Medizinische Hochschule Hannover on the 14th December 2006.

Study design

Prospective, international multi-centre open randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 1 diabetes mellitus

Intervention

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 conventional SMBG measurements. Patients of Group B will be required to wear the Guardian REAL-Time Clinical (blinded continuous glucose monitor) for 6 days prior to two visits.

Each subject will participate for 15 months, which includes 12 months treatment and 3 months follow-up. In total, there will be six study visits at the local site. Main timepoints of assessment are at baseline and 12 months thereafter. During study, patients will regularly attend the outpatient clinic according to local standard care. Analysis of HbA1c, diabetes-associated autoantibodies and fasting C-peptide will be performed during study.

As of 16/10/2009 this record was updated to include the correct sponsor details; at the time of registration, the funder was also indicated to be the sponsor.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/12/2006

Overall trial end date

31/08/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

160 patients will be recruited

Participant 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

Recruitment start date

01/12/2006

Recruitment end date

31/08/2009

Locations

Countries of recruitment

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

Trial participating centre

Kinderkrankenhaus auf der Bult
Hannover
30173
Germany

Sponsor information

Organisation

Hannover Childrens Hospital (Hannoversche Kinderheilanstalt) (Germany)

Sponsor details

Janusz-Korczak-Allee 12
Hannover
30173
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.hka.de/start.html

Funders

Funder type

Industry

Funder name

Medtronic International Trading Sarl (Switzerland) - donating equipment

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20711715
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22487079

Publication citations

  1. Results

    Kordonouri O, Pankowska E, Rami B, Kapellen T, Coutant R, Hartmann R, Lange K, Knip M, Danne T, Sensor-augmented pump therapy from the diagnosis of childhood type 1 diabetes: results of the Paediatric Onset Study (ONSET) after 12 months of treatment., Diabetologia, 2010, 53, 12, 2487-2495, doi: 10.1007/s00125-010-1878-6.

  2. Results

    Kordonouri O, Hartmann R, Pankowska E, Rami B, Kapellen T, Coutant R, Lange K, Danne T, Sensor augmented pump therapy from onset of type 1 diabetes: late follow-up results of the Pediatric Onset Study., Pediatr Diabetes, 2012, 13, 7, 515-518, doi: 10.1111/j.1399-5448.2012.00863.x.

Additional files

Editorial Notes