Effect of self-monitoring of glucose in non-insulin treated patients with type two diabetes

ISRCTN	ISRCTN84568563
DOI	https://doi.org/10.1186/ISRCTN84568563
Protocol serial number	NTR807
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	European Foundation for the Study of Diabetes (EFSD) (Germany)

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

VU Medical Centre Amsterdam
EMGO-Instituut
Afdeling Huisartsgeneeskunde
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 8395
Email	u.malanda@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised active-controlled parallel-group trial
Secondary study design	Randomised parallel trial
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(s)	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
Key secondary outcome measure(s)	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.
Completion date	01/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/04/2016	Yes	No
Results article	results	01/04/2016	Yes	No
Protocol article	protocol	27/04/2009	Yes	No

Editorial Notes

29/12/2016: Publication reference added.