| October 9, 2007 |
| March 13, 2009 |
| September 2007 |
| March 2009 (final data collection date for primary outcome measure) |
| Preference of the patient and amount of experienced hypoglycaemic events, bruises, backflow of insulin, bleeding and pain (VAS-scale) [ Time Frame: 4 months ] [ Designated as safety issue: No ] |
| Preference of the patient and amount of experienced hypoglycaemic events, bruises, backflow of insulin, bleeding and pain (VAS-scale) [ Time Frame: 4 months ] |
| Complete list of historical versions of study NCT00541372 on ClinicalTrials.gov Archive Site |
| HbA1c levels
1,5 anhydroglucitol and fructosamine levels
Insulin dose [ Time Frame: 4 months ] [ Designated as safety issue: No ] |
| HbA1c levels
1,5 anhydroglucitol and fructosamine levels
Insulin dose [ Time Frame: 4 months ] |
| |
| Needle Length In Obese Insulin-Using Diabetic Subjects |
| The Influence of the Needle Length on Long Term Glycaemic Control in Insulin Using Obese Diabetic Subjects |
For the administration of insulin, different needles are available with a length from 5 to 12.7mm. Insulin injections with a needle of 8 mm is injected in a lifted skinfold, a 5 mm needle can by used without lifting a skinfold (1). In the Netherlands obese people (BMI ≥ 30) are usually advised to use an 8mm or even longer needle (1). Increased BMI and the thickness of the subcutaneous tissue slow insulin absorption (2, 3, 4), possibly related to reduced subcutaneous blood flow. Furthermore, the capillaries are located just under the skin and between the fat and muscle layer. This could possibly determine the absorbing speed (2). It is not know if the administration of insulin with a 5mm needle by obese people has a different influence on the HbA1c compared to longer needles. The hypothesis of this study is that for the purpose of insulin injections, a 5 mm needle can be used without negative effects on metabolic parameters in patients with Diabetes Mellitus (DM) and a Body Mass Index (BMI) ≥ 30. |
| |
| Phase IV |
| Interventional |
| Supportive Care, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
| Diabetes Mellitus |
| Device: insulin injection needle size |
- Experimental: Needle 5 mm
- Active Comparator: Needle length 8 mm
|
| |
| |
| Completed |
| 130 |
| March 2009 |
| March 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
Patients who:
- change their own insulin dosage and are not prepared to keep a record of these changes
- have hypoglycaemia unawareness
- are pregnant or wish to become pregnant
- have a BMI < 30 kg/m2
- have a skinfold thickness <10mm
- have skin problems including lipodystrophy
|
| Both |
| 18 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Netherlands |
| |
| NCT00541372 |
| B.H.R. Wolffenbuttel, Univ Med Ctr Groningen |
| BWO-07001 |
| University Medical Centre Groningen |
| Martini Hospital Groningen |
| Principal Investigator: |
Bruce HR Wolffenbuttel, MD PhD |
University Medical Centre Groningen |
|
|
| University Medical Centre Groningen |
| March 2009 |