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

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

Study designRandomised active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe 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 acronymIN CONTROL
Study objectivesBy 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) studiedDiabetes Mellitus type two (DM2)
InterventionA 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 typeOther
Primary outcome measure1. 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 measures1. 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 date01/07/2007
Completion date01/11/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants600
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2007
Date of final enrolment01/11/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU Medical Centre Amsterdam
Amsterdam
1081 BT
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre

EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone +31 (0)20 444 8180
Email emgo@vumc.nl
Website http://www.vumc.nl/english/
ROR logo "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)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.