Diabetes Mellitus, Type 1NCT02637154
Motivational Interview in Adolescents With Poorly Controlled Type 1 Diabetes
A study testing Motivational Interviewing and Standard Education in people with Diabetes Mellitus, Type 1, run by Helsinki University Central Hospital at 3 sites in Finland.
Trial summary
This study investigates the effect of motivational interviewing and intensive education on HbA1c values and glucose variability in poorly controlled adolescent T1D patients. In the present study motivational interviewing (MI) will be integrated to clinicians' daily practice, as a part of normal clinical visit. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Motivational Interviewing and Standard Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFinland
- Study dates
- 15 Oct 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the diagnosis of type 1 diabetes with at least 2 years duration and HbA1c > 75 mmol/mol on two consecutive visits, age 12-15.9 years and pubertal (Tanner) stage 2 or more at inclusion
Who cannot join
- celiac disease with poor control; diagnosis of psychiatric disease; and other chronic disease requiring per oral glucocorticoid treatment
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Central Hospital, Pediatric Diabetes Unit Espoo
Espoo, 00029
Helsinki University Central Hospital, Pediatric Endocrinology Unit
Helsinki, 00029
Oulu University Hospital, Pediatric Endocrinology Unit
Oulu
About this study
Official title: The Effect of Motivational Interview and Intensive Education on HbA1C Values and Glucose Variability in Adolescents With Poorly Controlled Type 1 Diabetes
This study investigates the effect of motivational interviewing and intensive education on HbA1c values and glucose variability in poorly controlled adolescent T1D patients.
In the present study motivational interviewing (MI) will be integrated to clinicians' daily practice, as a part of normal clinical visit. In this randomized, controlled trial hypothesis is, that applying motivational interviewing during regular clinical visits results in better acceptance and subsequently enhanced metabolic control in adolescents with poorly controlled type 1 diabetes.
Read the detailed description
Background Type 1 diabetes (T1D) patients with optimal glycemic control suffer markedly less from long term diabetic complications than those with poor control. Increased glycohemoglobin (HbA1C) levels predict the complication risk. The development of diabetic complications seems to accelerate during puberty, and poor metabolic control during adolescence or young adulthood markedly increases the incidence of micro- or macrovascular complications during subsequent years. On the other hand, intensive treatment during adolescence has been reported to reduce the risk of microvascular complications, even if the control later on becomes poorer. This implicates that interventions targeting at improved glycemic control during adolescence probably have sustained beneficial effects on the overall morbidity in patients T1D.
The glycemic control of Finnish adolescents with T1D is poor. Insulin resistance and impaired metabolic control are common problems. Treatment of the disease during puberty can be complicated and particularly treatment adherence often declines in youth. Inexpensive and easily adoptable methods for clinicians are needed to overcome treatment problems faced with adolescent patients.
At present, there are no generally recommended approaches for clinicians to apply in order to motivate adolescents with poor glycemic control towards better treatment adherence. To this end, motivational interviewing (MI) has been used to an increasing degree in health care professionals in the treatment of variety of disorders and behavioral problems, such as alcohol and drug problems, gambling, and cardiovascular diseases. Motivational interviewing is a counseling approach designed to facilitate intrinsic motivation in the patient to change behavior. Significant body of evidence supports the view that MI improves commitment to care when added to other treatment. However, only a few studies have evaluated MI in the treatment of adolescent diabetes patients, with outcomes ranging from substantial benefit to neutral. MI is a promising approach for the treatment adolescent type 1 diabetics but there is a clear demand for methodologically solid studies.
Aims The aim of the present study is to investigate the effect of motivational interviewing and intensive education on HbA1c values and glucose variability in poorly controlled adolescent T1D patients. Secondarily, it will be investigated whether improved glycemic control is associated with improvements in vascular parameters, metabolic markers, markers of bone health and health related quality of life.
Hypothesis In the present study motivational interviewing (MI) will be integrated to clinicians' daily practice, as a part of normal clinical visit. In this randomized, controlled trial hypothesis is, that applying motivational interviewing during regular clinical visits results in better acceptance and subsequently enhanced metabolic control in adolescents with poorly controlled type 1 diabetes.
Study protocol All physicians participating in the study are trained to use standardized educational (SE) material. In addition half of the physicians are randomized to motivational interview (MI) group. They are trained by professor Martti Tuomisto's group to use MI in a one day workshop with refresher practical rehearsal course prior to study start. To secure that MI is sufficiently applied, the physician/patient discussions will be monitored by the Tuomisto group. All researchers randomized to the MI group will receive continuous feedback from the Tuomisto group on their performance (i.e. level of applying MI) and if needed re-trained for MI.
Patients with Hba1c > 75 mmol/mol are identified from hospital records, and are considered eligible for the current study. The patients willing to participate are randomized either to MI plus SE or SE group.
Study Protocol Every visit includes a physical examination (including evaluation of the stage of puberty and testis volume at the start and at 12 months), measurement of height, weight, growth velocity, body mass index (BMI), blood pressure and waist circumference, usage of SE material, and in the MI group usage of MI during the patient visit. The intervention in the MI group consists of a MI type of introduction at the beginning of each patient visit, and applying MI principles and procedures on each educational item discussed during the patient visit. Adherence to MI intervention protocols will be checked using recorded samples of therapy interactions. HbA1c levels are also measured in every visit.
Six days blinded continuous glucose monitoring will be performed at baseline and during the follow-up (0, 6 and 12 months).
Fasting venous blood samples are obtained at baseline and at 12 months. Investigators will evaluate health related quality of life (QoL) in study participants at baseline, and at completion of the study.
Dual- energy x-absorptiometry (DXA) is performed at baseline and at 12 months. Vascular assessments will be performed at baseline and at study completion.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Motivational Interviewing, Standard Education
- Keywords
- Adolescent, Type 1 diabetes, Metabolic control, Motivational interviewing
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Motivational Interviewing method
Standard EducationBehavioural
Standard Education material will be used
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Active comparator | With 30 patients Motivational Interviewing method will be used during each visit Receives: Behavioral: Motivational Interviewing |
| Standard Education | Active comparator | With 30 patients Standard Education material will be used during each visit Receives: Behavioral: Standard Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C values (mmol/mol)
HbA1c levels (mmol/mol) are measured in every visit (AfinionTM).
Measured: 12 months
Change in glycaemic variability
Six days blinded continuous glucose monitoring (CGM) (iPro, Medtronic) will be performed at baseline and during the follow-up. Blinded CGM curves (0 and 12mo) will be analyzed to study effect on glycemic variability. Standard deviation (SD) of blood glucose values and mean amplitude of glycemic excursions (MAGE) will be used as parameters to define glycemic variability.
Measured: 12 months
Secondary outcomes (11)
Influence of changes in markers of vascular health (IMT)
The association between glycemic control and vascular wall morphology is assessed by imaging of the carotid, femoral, brachial and radial artery intima media thickness (IMT as millimeters - mm:s) with ultrasound. Results will be compared to previously established measurements from healthy children. Vascular assessment will be performed at baseline and at study completion.
Measured: 12 months
Influence of changes in markers of vascular health (PWV)
The association between glycemic control and central and peripheral arterial thickness is assessed with pulse wave velocity (PWV - as meters / second - m/s) using applanation tonometry. Results will be compared to previously established measurements from healthy children. Vascular assessments will be performed at baseline and at study completion.
Measured: 12 months
Influence of changes in bone mineral density (BMD)
Dual- energy x-absorptiometry (DXA) is performed at baseline and at 12 months for analyses of BMD (total body less head, lumbar spine) and body composition, using the Hologic Discovery device (indicated as SD of Z-score).
Measured: 12 months
Influence of changes in quality of life
Health related quality of life (QoL) in study participants will be evaluated at baseline, and at completion of the study with the KINDL-R questionnaires
Measured: 12 months
Influence of changes in markers of inflammation (IL-6 - pg/ml)
Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of serum inflammatory marker serum IL-6.
Measured: 12 months
Influence of changes in markers of inflammation (high-sensitive-c-reactive-protein CRP - mg/l).
Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of serum inflammatory marker hs-CRP.
Measured: 12 months
Influence of changes in insulin-like-growth-factor IGF-I levels
Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of serum insulin-like-growth-factor IGF-I (ng/ml) levels.
Measured: 12 months
Influence of changes in markers of bone turnover (serum aminoterminal propeptide of type I collagen (PINP - ng/ml)).
Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of markers of bone turnover (PINP - ng/ml).
Measured: 12 months
Influence of changes in vitamin D status (25-hydroxy-D) ng/ml
Fasting venous blood samples are obtained at baseline and at 12 months for analysis of changes in vitamin D status.
Measured: 12 months
Influence of changes in marker of bone turnover: osteocalcin (ng/ml)
Fasting venous blood samples are obtained at baseline and at 12 months for analysis of changes in bone turnover marker osteocalcin.
Measured: 12 months
Influence of changes in marker of bone turnover: aminoterminal telopeptide of type I collagen (INTP - ng/ml)
Fasting venous blood samples are obtained at baseline and at 12 months for analysis of changes in bone turnover marker INTP.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start15 Oct 2015
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mari Pulkkinen, Helsinki University Central Hospital
- Investigators
- Mari Pulkkinen, MD PhD, Principal investigator, Specialist in Pediatric Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637154
- Sponsor's protocol ID
- MoHa
- Status last verified
- Aug 2018
- First submitted
- 10 Dec 2015
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group; Nathan DM, Zinman B, Cleary PA, Backlund JY, Genuth S, Miller R, Orchard TJ. Modern-day clinical course of type 1 diabetes mellitus after 30 years' duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and Pittsburgh epidemiology of diabetes complications experience (1983-2005). Arch Intern Med. 2009 Jul 27;169(14):1307-16. doi: 10.1001/archinternmed.2009.193.
PubMed 19636033Bryden KS, Dunger DB, Mayou RA, Peveler RC, Neil HA. Poor prognosis of young adults with type 1 diabetes: a longitudinal study. Diabetes Care. 2003 Apr;26(4):1052-7. doi: 10.2337/diacare.26.4.1052.
PubMed 12663572White NH, Cleary PA, Dahms W, Goldstein D, Malone J, Tamborlane WV; Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Beneficial effects of intensive therapy of diabetes during adolescence: outcomes after the conclusion of the Diabetes Control and Complications Trial (DCCT). J Pediatr. 2001 Dec;139(6):804-12. doi: 10.1067/mpd.2001.118887.
PubMed 11743505Channon S, Smith VJ, Gregory JW. A pilot study of motivational interviewing in adolescents with diabetes. Arch Dis Child. 2003 Aug;88(8):680-3. doi: 10.1136/adc.88.8.680.
PubMed 12876161Rubak S, Sandbaek A, Lauritzen T, Christensen B. Motivational interviewing: a systematic review and meta-analysis. Br J Gen Pract. 2005 Apr;55(513):305-12.
PubMed 15826439Service FJ, Molnar GD, Rosevear JW, Ackerman E, Gatewood LC, Taylor WF. Mean amplitude of glycemic excursions, a measure of diabetic instability. Diabetes. 1970 Sep;19(9):644-55. doi: 10.2337/diab.19.9.644. No abstract available.
PubMed 5469118Valerio G, del Puente A, Esposito-del Puente A, Buono P, Mozzillo E, Franzese A. The lumbar bone mineral density is affected by long-term poor metabolic control in adolescents with type 1 diabetes mellitus. Horm Res. 2002;58(6):266-72. doi: 10.1159/000066441.
PubMed 12446989Sarkola T, Redington A, Keeley F, Bradley T, Jaeggi E. Transcutaneous very-high-resolution ultrasound to quantify arterial wall layers of muscular and elastic arteries: validation of a method. Atherosclerosis. 2010 Oct;212(2):516-23. doi: 10.1016/j.atherosclerosis.2010.06.043. Epub 2010 Jul 7.
PubMed 20673898Pulkkinen MA, Tuomaala AK, Hero M, Gordin D, Sarkola T. Motivational Interview to improve vascular health in Adolescents with poorly controlled type 1 Diabetes (MIAD): a randomized controlled trial. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001216. doi: 10.1136/bmjdrc-2020-001216.
PubMed 32723754
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interview and Intensive Education on HbA1C Values and Glucose Variability in Adolescents With Poorly Controlled Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02637154
- Acronym / sponsor ID
- MoHa
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Adolescent, Type 1 diabetes, Metabolic control, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effect of motivational interviewing and intensive education on HbA1c values and glucose variability in poorly controlled adolescent T1D patients.
In the present study motivational interviewing (MI) will be integrated to clinicians' daily practice, as a part of normal clinical visit. In this randomized, controlled trial hypothesis is, that applying motivational interviewing during regular clinical visits results in better acceptance and subsequently enhanced metabolic control in adolescents with poorly controlled type 1 diabetes.
Detailed description
Background Type 1 diabetes (T1D) patients with optimal glycemic control suffer markedly less from long term diabetic complications than those with poor control. Increased glycohemoglobin (HbA1C) levels predict the complication risk. The development of diabetic complications seems to accelerate during puberty, and poor metabolic control during adolescence or young adulthood markedly increases the incidence of micro- or macrovascular complications during subsequent years. On the other hand, intensive treatment during adolescence has been reported to reduce the risk of microvascular complications, even if the control later on becomes poorer. This implicates that interventions targeting at improved glycemic control during adolescence probably have sustained beneficial effects on the overall morbidity in patients T1D.
The glycemic control of Finnish adolescents with T1D is poor. Insulin resistance and impaired metabolic control are common problems. Treatment of the disease during puberty can be complicated and particularly treatment adherence often declines in youth. Inexpensive and easily adoptable methods for clinicians are needed to overcome treatment problems faced with adolescent patients.
At present, there are no generally recommended approaches for clinicians to apply in order to motivate adolescents with poor glycemic control towards better treatment adherence. To this end, motivational interviewing (MI) has been used to an increasing degree in health care professionals in the treatment of variety of disorders and behavioral problems, such as alcohol and drug problems, gambling, and cardiovascular diseases. Motivational interviewing is a counseling approach designed to facilitate intrinsic motivation in the patient to change behavior. Significant body of evidence supports the view that MI improves commitment to care when added to other treatment. However, only a few studies have evaluated MI in the treatment of adolescent diabetes patients, with outcomes ranging from substantial benefit to neutral. MI is a promising approach for the treatment adolescent type 1 diabetics but there is a clear demand for methodologically solid studies.
Aims The aim of the present study is to investigate the effect of motivational interviewing and intensive education on HbA1c values and glucose variability in poorly controlled adolescent T1D patients. Secondarily, it will be investigated whether improved glycemic control is associated with improvements in vascular parameters, metabolic markers, markers of bone health and health related quality of life.
Hypothesis In the present study motivational interviewing (MI) will be integrated to clinicians' daily practice, as a part of normal clinical visit. In this randomized, controlled trial hypothesis is, that applying motivational interviewing during regular clinical visits results in better acceptance and subsequently enhanced metabolic control in adolescents with poorly controlled type 1 diabetes.
Study protocol All physicians participating in the study are trained to use standardized educational (SE) material. In addition half of the physicians are randomized to motivational interview (MI) group. They are trained by professor Martti Tuomisto's group to use MI in a one day workshop with refresher practical rehearsal course prior to study start. To secure that MI is sufficiently applied, the physician/patient discussions will be monitored by the Tuomisto group. All researchers randomized to the MI group will receive continuous feedback from the Tuomisto group on their performance (i.e. level of applying MI) and if needed re-trained for MI.
Patients with Hba1c > 75 mmol/mol are identified from hospital records, and are considered eligible for the current study. The patients willing to participate are randomized either to MI plus SE or SE group.
Study Protocol Every visit includes a physical examination (including evaluation of the stage of puberty and testis volume at the start and at 12 months), measurement of height, weight, growth velocity, body mass index (BMI), blood pressure and waist circumference, usage of SE material, and in the MI group usage of MI during the patient visit. The intervention in the MI group consists of a MI type of introduction at the beginning of each patient visit, and applying MI principles and procedures on each educational item discussed during the patient visit. Adherence to MI intervention protocols will be checked using recorded samples of therapy interactions. HbA1c levels are also measured in every visit.
Six days blinded continuous glucose monitoring will be performed at baseline and during the follow-up (0, 6 and 12 months).
Fasting venous blood samples are obtained at baseline and at 12 months. Investigators will evaluate health related quality of life (QoL) in study participants at baseline, and at completion of the study.
Dual- energy x-absorptiometry (DXA) is performed at baseline and at 12 months. Vascular assessments will be performed at baseline and at study completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Active comparator | Behavioral: Motivational InterviewingWith 30 patients Motivational Interviewing method will be used during each visit |
| Standard Education | Active comparator | Behavioral: Standard EducationWith 30 patients Standard Education material will be used during each visit |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- the diagnosis of type 1 diabetes with at least 2 years duration and HbA1c > 75 mmol/mol on two consecutive visits, age 12-15.9 years and pubertal (Tanner) stage 2 or more at inclusion
Key exclusion criteria (1 listed)
- celiac disease with poor control; diagnosis of psychiatric disease; and other chronic disease requiring per oral glucocorticoid treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingMotivational Interviewing method | Behavioural | Motivational Interviewing |
| Standard EducationStandard Education material will be used | Behavioural | Standard Education |
Primary outcome
Change in HbA1C values (mmol/mol)
Time frame: 12 months
HbA1c levels (mmol/mol) are measured in every visit (AfinionTM).
Change in glycaemic variability
Time frame: 12 months
Six days blinded continuous glucose monitoring (CGM) (iPro, Medtronic) will be performed at baseline and during the follow-up. Blinded CGM curves (0 and 12mo) will be analyzed to study effect on glycemic variability. Standard deviation (SD) of blood glucose values and mean amplitude of glycemic excursions (MAGE) will be used as parameters to define glycemic variability.
11 secondary outcomes
Influence of changes in markers of vascular health (IMT)
Time frame: 12 months
Influence of changes in markers of vascular health (PWV)
Time frame: 12 months
Influence of changes in bone mineral density (BMD)
Time frame: 12 months
Influence of changes in quality of life
Time frame: 12 months
Influence of changes in markers of inflammation (IL-6 - pg/ml)
Time frame: 12 months
Influence of changes in markers of inflammation (high-sensitive-c-reactive-protein CRP - mg/l).
Time frame: 12 months
Influence of changes in insulin-like-growth-factor IGF-I levels
Time frame: 12 months
Influence of changes in markers of bone turnover (serum aminoterminal propeptide of type I collagen (PINP - ng/ml)).
Time frame: 12 months
Influence of changes in vitamin D status (25-hydroxy-D) ng/ml
Time frame: 12 months
Influence of changes in marker of bone turnover: osteocalcin (ng/ml)
Time frame: 12 months
Influence of changes in marker of bone turnover: aminoterminal telopeptide of type I collagen (INTP - ng/ml)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Background: PubMed 19636033Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group; Nathan DM, Zinman B, Cleary PA, Backlund JY, Genuth S, Miller R, Orchard TJ. Modern-day clinical course of type 1 diabetes mellitus after 30 years' duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and Pittsburgh epidemiology of diabetes complications experience (1983-2005). Arch Intern Med. 2009 Jul 27;169(14):1307-16. doi: 10.1001/archinternmed.2009.193.
- Background: PubMed 12663572Bryden KS, Dunger DB, Mayou RA, Peveler RC, Neil HA. Poor prognosis of young adults with type 1 diabetes: a longitudinal study. Diabetes Care. 2003 Apr;26(4):1052-7. doi: 10.2337/diacare.26.4.1052.
- Background: PubMed 11743505White NH, Cleary PA, Dahms W, Goldstein D, Malone J, Tamborlane WV; Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Beneficial effects of intensive therapy of diabetes during adolescence: outcomes after the conclusion of the Diabetes Control and Complications Trial (DCCT). J Pediatr. 2001 Dec;139(6):804-12. doi: 10.1067/mpd.2001.118887.
- Background: PubMed 12876161Channon S, Smith VJ, Gregory JW. A pilot study of motivational interviewing in adolescents with diabetes. Arch Dis Child. 2003 Aug;88(8):680-3. doi: 10.1136/adc.88.8.680.
- Background: PubMed 15826439Rubak S, Sandbaek A, Lauritzen T, Christensen B. Motivational interviewing: a systematic review and meta-analysis. Br J Gen Pract. 2005 Apr;55(513):305-12.
- Background: PubMed 5469118Service FJ, Molnar GD, Rosevear JW, Ackerman E, Gatewood LC, Taylor WF. Mean amplitude of glycemic excursions, a measure of diabetic instability. Diabetes. 1970 Sep;19(9):644-55. doi: 10.2337/diab.19.9.644. No abstract available.
- Background: PubMed 12446989Valerio G, del Puente A, Esposito-del Puente A, Buono P, Mozzillo E, Franzese A. The lumbar bone mineral density is affected by long-term poor metabolic control in adolescents with type 1 diabetes mellitus. Horm Res. 2002;58(6):266-72. doi: 10.1159/000066441.
- Background: PubMed 20673898Sarkola T, Redington A, Keeley F, Bradley T, Jaeggi E. Transcutaneous very-high-resolution ultrasound to quantify arterial wall layers of muscular and elastic arteries: validation of a method. Atherosclerosis. 2010 Oct;212(2):516-23. doi: 10.1016/j.atherosclerosis.2010.06.043. Epub 2010 Jul 7.
- Derived from this study: PubMed 32723754Pulkkinen MA, Tuomaala AK, Hero M, Gordin D, Sarkola T. Motivational Interview to improve vascular health in Adolescents with poorly controlled type 1 Diabetes (MIAD): a randomized controlled trial. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001216. doi: 10.1136/bmjdrc-2020-001216.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mari Pulkkinen, MD PhD principal investigator
Specialist in Pediatric Endocrinology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Standard Education in people with Diabetes Mellitus, Type 1, run by Helsinki University Central Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1C values (mmol/mol) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637154, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.