The necessity of an injection-meal-interval in patients with type 2 diabetes mellitus and therapy with human insulin

ISRCTN	ISRCTN04277490
DOI	https://doi.org/10.1186/ISRCTN04277490
ClinicalTrials.gov (NCT)	NCT00529165
Protocol serial number	N/A
Sponsor	University Hospital Jena (Germany)
Funder	University of Jena (Germany)

Submission date: 14/08/2007
Registration date: 12/09/2007
Last edited: 01/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ulrich Alfons Muller
Scientific

University Hospital Jena
Department of Internal Medicine III
Bachstr. 18
Jena
07743
Germany

Email	ulrichalfons.mueller@med.uni-jena.de

Study information

Primary study design	Interventional
Study design	Monocentric, open, randomised, two-phased, cross-over design.
Secondary study design	Randomised controlled trial
Scientific title	Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin
Study objectives	There is no difference in metabolic control in patients with type 2 diabetes mellitus and therapy with human insulin with or without injection-meal-interval.
Ethics approval(s)	Ethics approval received from the Friedrich Schiller University Ethics Committee on the 10th October 2006 (ref: 1855-09/06).
Health condition(s) or problem(s) studied	Diabetes mellitus type 2
Intervention	The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences: 1. Group A: with injection-meal-interval: 50 patients educated to inject the insulin with an injection-meal-interval of 15 minutes 2. Group B: without injection-meal-interval: 50 patients educated to inject the insulin without injection-meal-interval Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Human insulin
Primary outcome measure(s)	HbA1c, measured from venous blood samples from the finger at baseline and weeks 4, 16 and 28.
Key secondary outcome measure(s)	1. Frequency of hypoglycaemia, measured at 4 and 28 weeks 2. Quality of life, measured using the Audit of Diabetes-Dependent Quality of Life (ADDQoL) at weeks 4, 16 and 28 3. Satisfaction of quality of care, measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at weeks 4, 16 and 28
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Type 2 diabetes mellitus 2. Aged 40 - 80 years 3. Therapy with human insulin
Key exclusion criteria	1. Pregnancy 2. Nutrition disorders 3. Psychological disease 4. Body Mass Index (BMI) less than 25 kg/m^2 5. HbA1c greater than 9%
Date of first enrolment	01/07/2007
Date of final enrolment	01/07/2008

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital Jena

Jena
07743
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2013	01/02/2019	Yes	No

Editorial Notes

01/02/2019: Publication reference added