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Motivational Interview in Adolescents With Poorly Controlled Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02637154
Recruitment Status : Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mari Pulkkinen, Helsinki University Central Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Behavioral: Motivational Interviewing Behavioral: Standard Education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effect of Motivational Interview and Intensive Education on HbA1C Values and Glucose Variability in Adolescents With Poorly Controlled Type 1 Diabetes
Actual Study Start Date : October 15, 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Motivational Interviewing
With 30 patients Motivational Interviewing method will be used during each visit
Behavioral: Motivational Interviewing
Motivational Interviewing method

Active Comparator: Standard Education
With 30 patients Standard Education material will be used during each visit
Behavioral: Standard Education
Standard Education material will be used




Primary Outcome Measures :
  1. Change in HbA1C values (mmol/mol) [ Time Frame: 12 months ]
    HbA1c levels (mmol/mol) are measured in every visit (AfinionTM).

  2. 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.


Secondary Outcome Measures :
  1. Influence of changes in markers of vascular health (IMT) [ Time Frame: 12 months ]
    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.

  2. Influence of changes in markers of vascular health (PWV) [ Time Frame: 12 months ]
    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.

  3. Influence of changes in bone mineral density (BMD) [ Time Frame: 12 months ]
    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).

  4. Influence of changes in quality of life [ Time Frame: 12 months ]
    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

  5. Influence of changes in markers of inflammation (IL-6 - pg/ml) [ Time Frame: 12 months ]
    Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of serum inflammatory marker serum IL-6.

  6. Influence of changes in markers of inflammation (high-sensitive-c-reactive-protein CRP - mg/l). [ Time Frame: 12 months ]
    Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of serum inflammatory marker hs-CRP.

  7. Influence of changes in insulin-like-growth-factor IGF-I levels [ Time Frame: 12 months ]
    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.

  8. Influence of changes in markers of bone turnover (serum aminoterminal propeptide of type I collagen (PINP - ng/ml)). [ Time Frame: 12 months ]
    Fasting venous blood samples are obtained at baseline and at 12 months for later analysis of markers of bone turnover (PINP - ng/ml).

  9. Influence of changes in vitamin D status (25-hydroxy-D) ng/ml [ Time Frame: 12 months ]
    Fasting venous blood samples are obtained at baseline and at 12 months for analysis of changes in vitamin D status.

  10. Influence of changes in marker of bone turnover: osteocalcin (ng/ml) [ Time Frame: 12 months ]
    Fasting venous blood samples are obtained at baseline and at 12 months for analysis of changes in bone turnover marker osteocalcin.

  11. Influence of changes in marker of bone turnover: aminoterminal telopeptide of type I collagen (INTP - ng/ml) [ Time Frame: 12 months ]
    Fasting venous blood samples are obtained at baseline and at 12 months for analysis of changes in bone turnover marker INTP.



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • celiac disease with poor control; diagnosis of psychiatric disease; and other chronic disease requiring per oral glucocorticoid treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637154


Locations
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Finland
Helsinki University Central Hospital, Pediatric Diabetes Unit Espoo
Espoo, Finland, 00029
Helsinki University Central Hospital, Pediatric Endocrinology Unit
Helsinki, Finland, 00029
Oulu University Hospital, Pediatric Endocrinology Unit
Oulu, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Mari Pulkkinen, MD PhD Specialist in Pediatric Endocrinology

Publications:

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Responsible Party: Mari Pulkkinen, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02637154     History of Changes
Other Study ID Numbers: MoHa
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mari Pulkkinen, Helsinki University Central Hospital:
Adolescent
Type 1 diabetes
Metabolic control
Motivational interviewing

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases