Motivational Interview in Adolescents With Poorly Controlled Type 1 Diabetes

NCT02637154 | Unknown

• 1 other identifier: MoHa
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Adolescent; Type 1 diabetes; Metabolic control; Motivational interviewing

Outcome Measures

Primary Outcomes (2)

• Change in HbA1C values (mmol/mol)

  HbA1c levels (mmol/mol) are measured in every visit (AfinionTM).

  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.

  12 months

Secondary Outcomes (11)

• Influence of changes in markers of vascular health (IMT)

  12 months

• Influence of changes in markers of vascular health (PWV)

  12 months

• Influence of changes in bone mineral density (BMD)

  12 months

• Influence of changes in quality of life

  12 months

• Influence of changes in markers of inflammation (IL-6 - pg/ml)

  12 months

Study Arms (2)

Motivational Interviewing

ACTIVE COMPARATOR

With 30 patients Motivational Interviewing method will be used during each visit

Behavioral: Motivational Interviewing

Standard Education

ACTIVE COMPARATOR

With 30 patients Standard Education material will be used during each visit

Behavioral: Standard Education

Interventions

Motivational Interviewing BEHAVIORAL

Motivational Interviewing method

Motivational Interviewing

Standard Education BEHAVIORAL

Standard Education material will be used

Standard Education

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (3)

Helsinki University Central Hospital, Pediatric Diabetes Unit Espoo

Espoo, 00029, Finland

Location

Helsinki University Central Hospital, Pediatric Endocrinology Unit

Helsinki, 00029, Finland

Location

Oulu University Hospital, Pediatric Endocrinology Unit

Oulu, Finland

Location

Related Publications (9)

• 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.

  PMID: 19636033 BACKGROUND

• Bryden 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.

  PMID: 12663572 BACKGROUND

• White 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.

  PMID: 11743505 BACKGROUND

• Channon 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.

  PMID: 12876161 BACKGROUND

• Rubak 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.

  PMID: 15826439 BACKGROUND

• Service 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.

  PMID: 5469118 BACKGROUND

• Valerio 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.

  PMID: 12446989 BACKGROUND

• Sarkola 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.

  PMID: 20673898 BACKGROUND

• Pulkkinen 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.

  PMID: 32723754 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mari Pulkkinen, MD PhD

  Specialist in Pediatric Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 22, 2015
• Study Start: October 15, 2015
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)