Effect of self-monitoring of glucose in non-insulin treated patients with type two diabetes
| ISRCTN | ISRCTN84568563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84568563 |
| Secondary identifying numbers | NTR807 |
- Submission date
- 02/05/2007
- Registration date
- 02/05/2007
- Last edited
- 29/12/2016
- 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
Ms U.L. Malanda
Scientific
Scientific
VU Medical Centre Amsterdam
EMGO-Instituut
Afdeling Huisartsgeneeskunde
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8395 |
|---|---|
| u.malanda@vumc.nl |
Study information
| Study design | Randomised active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | The effect of self monitoring of blood glucose and urine glucose relative to usual care without self monitoring on diabetes related distress and glycaemic control in patients with type 2 diabetes who are not using insulin |
| Study acronym | IN CONTROL |
| Study objectives | By applying self monitoring of glucose, patients with Diabetes Mellitus type two (DM2) may cope more independently with their disease. Self monitoring can aid in diabetes control by giving the patient the ability to make appropriate day-to-day treatment choices in diet and physical activity as well as in medication. Furthermore, it will improve a patient's recognition of hypoglycaemia or severe hyperglycaemia, and enhance patient empowerment regarding the effects of lifestyle and medication on glycaemic control and thereby provide a better perceived quality of life. Please note that as of 26/10/2009 this trial was updated. All updates can be found under the relevant field with the above update date. The overall trial end date has been extended from 01/07/2009. |
| Ethics approval(s) | The ethics board of the VU Medical Centre, 22/11/2007 |
| Health condition(s) or problem(s) studied | Diabetes Mellitus type two (DM2) |
| Intervention | A stratified, randomised six-arm clinical trial among DM2 patients with an Hb1Ac of 7.0% or above who are not using insulin. Eligible and consenting subjects will be randomly assigned to the intervention groups Self Monitoring of Blood Glucose (SMBG) or Self Monitoring of Urine Glucose (SMUG), or to the control group. Before randomisation the patients will be stratified according to treatment (i.e. using Sulphonylureas [SU] or not [Non-SU]). The SMBG and SMUG will be an integral part of a wider educational strategy; the intervention groups and the control group will receive a standardised treatment program to change their diet and lifestyle. In addition, patients in the SMBG group will be educated to use the SMBG-device and patients in the SMUG-group will be educated to use the urine tests. They will learn to know and understand the ranges of test results and what steps to take in response to a high or low, or positive or negative reading. The intervention groups will perform self-monitoring according to standard testing frequency instructions during one year. |
| Intervention type | Other |
| Primary outcome measure | 1. Problem Areas In Diabetes scale (PAID) assessed at baseline and at 6 and 12 months after inclusion 2. Glycaemic control measured by glycated haemoglobin concentration (HbA1c-level) at baseline and at 6 and 12 months after inclusion 3. Cost-effectiveness assessed using cost-diaries and the European Quality of Life (EuroQoL) questionnaire |
| Secondary outcome measures | 1. Frequency and severity of hypoglycaemia 2. Change in well-being: 12-item Well Being Questionnaire (WBQ-12) 3. Patient satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQ) 4. Changes in lifestyle factors: a. diet behaviour (Dutch Eating Behaviour Questionnaire [DEBQ]) b. physical activity (Short Questionnaire to Assess Health enhancing physical activity [SQUASH]) 5. Changes in medication use 6. Compliance 7. Medical care utilisation All secondary outcomes will be assessed at baseline, 6 and 12 months after inclusion. |
| Overall study start date | 01/07/2007 |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | 1. All patients are participants of the Diabetes Care System West-Friesland 2. Patients with type two diabetes with HbA1c levels of 7.0% or above who are not using insulin 3. Younger than 76 years 4. Known disease duration of over one year 5. Not used self monitoring of glucose in the previous year |
| Key exclusion criteria | 1. Severe complications of diabetes 2. Pregnant women 3. Unable to carry out self monitoring of glucose 4. Unable to fill in questionnaires/diaries |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/11/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU Medical Centre Amsterdam
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8180 |
|---|---|
| emgo@vumc.nl | |
| Website | http://www.vumc.nl/english/ |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research organisation
European Foundation for the Study of Diabetes (EFSD) (Germany)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The European Association for the Study of Diabetes, EFSD
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/04/2009 | Yes | No | |
| Results article | results | 01/04/2016 | Yes | No | |
| Results article | results | 01/04/2016 | Yes | No |
Editorial Notes
29/12/2016: Publication reference added.
