Contact information
Type
Scientific
Primary contact
Ms U.L. Malanda
ORCID ID
Contact details
VU Medical Centre Amsterdam
EMGO-Instituut
Afdeling Huisartsgeneeskunde
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8395
u.malanda@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR807
Study information
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
Acronym
IN CONTROL
Study hypothesis
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
The ethics board of the VU Medical Centre, 22/11/2007
Study design
Randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/07/2007
Overall trial end date
01/11/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
01/11/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU Medical Centre Amsterdam
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
European Foundation for the Study of Diabetes (EFSD) (Germany)
Alternative name(s)
EFSD
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Germany
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
Basic results (scientific)
Publication list
2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19397795
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26171942
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26171942
Publication citations
-
Protocol
Malanda UL, Bot SD, Kostense PJ, Snoek FJ, Dekker JM, Nijpels G, Effects of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes: design of the IN CONTROL-trial., BMC Fam Pract, 2009, 10, 26, doi: 10.1186/1471-2296-10-26.
-
Results
Malanda UL, M Bot SD, Kostense PJ, Snoek FJ, Dekker JM, Nijpels G, Effects of self-monitoring of glucose on distress and self-efficacy in people with non-insulin-treated Type 2 diabetes: a randomized controlled trial, Diabet Med, 2015 , doi: 10.1111/dme.12849.