CGM Treatment in Patients With Type 1 Diabetes Treated With Insulin Injections

NCT02092051 | Completed DMC

• 1 other identifier: CGMMDI
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 15

Brief Summary

Breif summary A keystone in preventing diabetic complications in patients with type 1 diabetes is good glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels has been an essential part of insulin dosing before meals. However, in recent years continuous glucose monitoring (CGM) has become a treatment option for notifying the patient on trends in glucose levels and warning when these are estimated to be too high and too low. In some countries today, Sweden among others, CGM is reimbursed in combination with continuous subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control or a history of repeated severe hypoglycaemia in adult type 1 diabetic patients. This is based on existing clinical trials showing a beneficial effect on HbA1c by combining CGM with CSII. However, the majority of adult type 1 diabetic patients are treated with multiple daily insulin injections (MDI). Clinical trial data are sparse on the effect of CGM in adult type 1 diabetic patients treated with MDI, and there are no clinical trial data including only patients on MDI. The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction among adult type 1 diabetic patients on CGM treated with MDI. The design is a 69-week, cross-over clinical trial, including 26 weeks treatment with CGM, 26 weeks treatment with conventional SMBG and a wash-out period of 17 weeks. In total 120 patients will be included at 8 sites in Sweden. The study will have 80% power to detect a 3 mmol/mol (0.3 percentage unit) change in HbA1c resulting from CGM.

Conditions

Diabetes Mellitus, Type 1

Keywords

Continuous glucose monitoring; Type 1 diabetes; Insulin injections; Cross-over

Outcome Measures

Primary Outcomes (1)

• Difference in HbA1c between week 26 and week 69

  Week 26, week 69

Secondary Outcomes (14)

• Difference in mean glucose level measured by CGM between week 23-26 and 66-69

  Week 23-26, week 66-69

• Difference in mean amplitude glucose excursion (MAGE) measured by CGM between week 23-26 and week 66-69

  Week 23-26, week 66-69

• Difference in standard deviation of glucose levels measured by CGM between week 23-26 and week 66-69

  Week 23-26 and week 66-69

• Difference in DTSQs scores between weeks 26 and 69

  Week 26, week 69

• DTSQc score at week 69

  Week 69

Study Arms (2)

Continuous glucose monitoring

EXPERIMENTAL

Continuous glucose monitoring with DexCom G4 platina during 6 months

Device: Continuous glucose monitoring with DexCom G4 platina

Conventional therapy

NO INTERVENTION

Conventional therapy during 6 months using only SMBG for glucose monitoring

Interventions

Continuous glucose monitoring with DexCom G4 platina DEVICE

Continuous glucose monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes
• Adults 18 years or older
• Written Informed Consent
• HbA1c greater than or equal to 58 mmol/mol (7.5% DCCT standard)

You may not qualify if:

• Pregnancy, planned pregnancy for the study duration or pregnancy during the last six months
• Required continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during CGM-use because it disturbs the interpretation of blood glucose levels estimated by the DexComG4. However, other pain killers can be used throughout the study duration.
• Current CGM use. (within the past 4 months
• History of allergic reaction to any of the CGMS materials or adhesives in contact with the skin.
• History of allergic reaction to chlorhexidine or alcohol antiseptic solution.
• Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
• Patient is uncomfortable by using the sensor during the blinded run-in period and believes it is unlikely that he/she will use the sensor more than 80% of the time during the trial.
• The patient has on average performed 12 or less calibrations per week during the run-in period.
• Insulin pump therapy=Continuous subcutaneous insulin infusion (CSII)
• Diabetes duration \< 1 year
• Participation in another study.
• Fasting C-peptide level of 0.3 nmol/l or higher
• Planned house move during the next 1.5 years, making it difficult to come to study visits
• Other investigator-determined criteria making patients unsuitable for participation.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• DexCom, Inc.: collaborator

Study Sites (15)

Alingsås Hospital

Alingsås, 44183, Sweden

Location

Angered Hospital

Angered, 42422, Sweden

Location

Ängelholm Hospital

Ängelholm, 262 81, Sweden

Location

Öbackakliniken

Härnösand, 871 82, Sweden

Location

Helsingborg Hospital

Helsingborg, 25187, Sweden

Location

Centralhospital Kristianstad

Kristianstad, 29185, Sweden

Location

Halland's Hospital Kungsbacka

Kungsbacka, 43480, Sweden

Location

Malmö University Hospital

Malmo, 205 02, Sweden

Location

Motala Hospital

Motala, 591 85, Sweden

Location

Vrinnevisjukhuset

Norrköping, 603 82, Sweden

Location

University Hospital Örebro

Örebro, 70185, Sweden

Location

Södersjukhuset

Stockholm, 118 81, Sweden

Location

Trelleborg Hospital

Trelleborg, 231 85, Sweden

Location

Uddevalla Hospital

Uddevalla, 45180, Sweden

Location

Academic Hospital Uppsala

Uppsala, 75185, Sweden

Location

Related Publications (16)

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  PMID: 8366922 BACKGROUND

• Misso ML, Egberts KJ, Page M, O'Connor D, Shaw J. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD005103. doi: 10.1002/14651858.CD005103.pub2.

  PMID: 20091571 BACKGROUND

• Hansen MV, Pedersen-Bjergaard U, Heller SR, Wallace TM, Rasmussen AK, Jorgensen HV, Pramming S, Thorsteinsson B. Frequency and motives of blood glucose self-monitoring in type 1 diabetes. Diabetes Res Clin Pract. 2009 Aug;85(2):183-8. doi: 10.1016/j.diabres.2009.04.022. Epub 2009 Jun 3.

  PMID: 19497633 BACKGROUND

• Miller KM, Beck RW, Bergenstal RM, Goland RS, Haller MJ, McGill JB, Rodriguez H, Simmons JH, Hirsch IB; T1D Exchange Clinic Network. Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants. Diabetes Care. 2013 Jul;36(7):2009-14. doi: 10.2337/dc12-1770. Epub 2013 Feb 1.

  PMID: 23378621 BACKGROUND

• Evans JM, Newton RW, Ruta DA, MacDonald TM, Stevenson RJ, Morris AD. Frequency of blood glucose monitoring in relation to glycaemic control: observational study with diabetes database. BMJ. 1999 Jul 10;319(7202):83-6. doi: 10.1136/bmj.319.7202.83.

  PMID: 10398627 BACKGROUND

• Hirsch IB. Clinical review: Realistic expectations and practical use of continuous glucose monitoring for the endocrinologist. J Clin Endocrinol Metab. 2009 Jul;94(7):2232-8. doi: 10.1210/jc.2008-2625. Epub 2009 Apr 21.

  PMID: 19383778 BACKGROUND

• Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.

  PMID: 21737469 BACKGROUND

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.

  PMID: 18779236 BACKGROUND

• Battelino T, Conget I, Olsen B, Schutz-Fuhrmann I, Hommel E, Hoogma R, Schierloh U, Sulli N, Bolinder J; SWITCH Study Group. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia. 2012 Dec;55(12):3155-62. doi: 10.1007/s00125-012-2708-9. Epub 2012 Sep 11.

  PMID: 22965294 BACKGROUND

• Riveline JP, Schaepelynck P, Chaillous L, Renard E, Sola-Gazagnes A, Penfornis A, Tubiana-Rufi N, Sulmont V, Catargi B, Lukas C, Radermecker RP, Thivolet C, Moreau F, Benhamou PY, Guerci B, Leguerrier AM, Millot L, Sachon C, Charpentier G, Hanaire H; EVADIAC Sensor Study Group. Assessment of patient-led or physician-driven continuous glucose monitoring in patients with poorly controlled type 1 diabetes using basal-bolus insulin regimens: a 1-year multicenter study. Diabetes Care. 2012 May;35(5):965-71. doi: 10.2337/dc11-2021. Epub 2012 Mar 28.

  PMID: 22456864 BACKGROUND

• Hirsch IB. Insulin analogues. N Engl J Med. 2005 Jan 13;352(2):174-83. doi: 10.1056/NEJMra040832. No abstract available.

  PMID: 15647580 BACKGROUND

• Anderbro T, Amsberg S, Wredling R, Lins PE, Adamson U, Lisspers J, Johansson UB. Psychometric evaluation of the Swedish version of the Hypoglycaemia Fear Survey. Patient Educ Couns. 2008 Oct;73(1):127-31. doi: 10.1016/j.pec.2008.03.022. Epub 2008 May 8.

  PMID: 18472383 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Seyed Ahmadi S, Westman K, Pivodic A, Olafsdottir AF, Dahlqvist S, Hirsch IB, Hellman J, Ekelund M, Heise T, Polonsky W, Wijkman M, Schwarcz E, Lind M. The Association Between HbA1c and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4). Diabetes Care. 2020 Sep;43(9):2017-2024. doi: 10.2337/dc19-2606. Epub 2020 Jul 8.

  PMID: 32641374 DERIVED

• Olafsdottir AF, Polonsky W, Bolinder J, Hirsch IB, Dahlqvist S, Wedel H, Nystrom T, Wijkman M, Schwarcz E, Hellman J, Heise T, Lind M. A Randomized Clinical Trial of the Effect of Continuous Glucose Monitoring on Nocturnal Hypoglycemia, Daytime Hypoglycemia, Glycemic Variability, and Hypoglycemia Confidence in Persons with Type 1 Diabetes Treated with Multiple Daily Insulin Injections (GOLD-3). Diabetes Technol Ther. 2018 Apr;20(4):274-284. doi: 10.1089/dia.2017.0363. Epub 2018 Apr 2.

  PMID: 29608107 DERIVED

• Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Olafsdottir AF, Frid A, Wedel H, Ahlen E, Nystrom T, Hellman J. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):379-387. doi: 10.1001/jama.2016.19976.

  PMID: 28118454 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

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)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Marcus Lind, MD, PhD

  NU-Hospital Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 19, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 10, 2017

Record last verified: 2016-11

Locations

SE (15)