Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
17/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.vumc.nl/english/

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

Results - basic reporting

Publication summary

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19397795
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26171942

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes