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

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ClinicalTrials.gov Identifier: NCT02092051
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Vastra Gotaland Region

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Continuous glucose monitoring with DexCom G4 platina Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Effect of Continuous Glucose Monitoring (CGM) in Individuals With Type 1 Diabetes Treated With Multiple Daily Insulin Injections (MDI)
Study Start Date : January 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Continuous glucose monitoring
Continuous glucose monitoring with DexCom G4 platina during 6 months
Device: Continuous glucose monitoring with DexCom G4 platina
No Intervention: Conventional therapy
Conventional therapy during 6 months using only SMBG for glucose monitoring



Primary Outcome Measures :
  1. Difference in HbA1c between week 26 and week 69 [ Time Frame: Week 26, week 69 ]

Secondary Outcome Measures :
  1. Difference in mean glucose level measured by CGM between week 23-26 and 66-69 [ Time Frame: Week 23-26, week 66-69 ]
  2. Difference in mean amplitude glucose excursion (MAGE) measured by CGM between week 23-26 and week 66-69 [ Time Frame: Week 23-26, week 66-69 ]
  3. Difference in standard deviation of glucose levels measured by CGM between week 23-26 and week 66-69 [ Time Frame: Week 23-26 and week 66-69 ]
  4. Difference in DTSQs scores between weeks 26 and 69 [ Time Frame: Week 26, week 69 ]
  5. DTSQc score at week 69 [ Time Frame: Week 69 ]
  6. Difference in WHO 5 scores between weeks 26 and 69 [ Time Frame: Week 26, week 69 ]
  7. Difference in SWE-HFS scores between weeks 26 and 69 [ Time Frame: Week 26, week 69 ]
  8. Difference in SWE-PAID-20 scores between weeks 26 and 69 [ Time Frame: Week 26, week 69 ]
  9. Difference in the proportion of time with low glucose levels measured by CGM during two weeks between week 23-26 and week 66-69 measured by CGM (below 3.0 mmol/l and below 4.0 mmol/l respectively) [ Time Frame: Week 23-26, week 66-69 ]
  10. Difference in the proportion of time with high glucose levels measured by CGM during two weeks between week 23-26 and week 66-69 measured by CGM (above 10.0 mmol/l and above 13.9 mmol/l respectively) [ Time Frame: Week 23-26, week 66-69 ]
  11. Difference in the proportion of time with euglycaemic levels measured by CGM during two weeks between weeks 23-26 and weeks 66-69 (5.5-10.0 mmol/l and 3.9-10.0 mmol/l respectively) [ Time Frame: Week 23-26, week 66-69 ]
  12. Difference in the proportion of patients reducing their HbA1c by 5 mmol/mol (0.5% in DCCT) or more [ Time Frame: Week 26, week 69 ]
  13. Difference in the proportion of patients lowering their HbA1c 10 mmol/mol (1% in DCCT) or more [ Time Frame: Week 26, week 69 ]
  14. Difference in the mean number of severe hypoglycaemic events between weeks 1-26 and weeks 43-69 defined as unconsciousness due to hypoglycaemia or need of assistance from another person to resolve the hypoglycaemia [ Time Frame: Week 1-26, week 43-69 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy, planned pregnancy for the study duration or pregnancy during the last six months
  • Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion.
  • 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
  • eGFR < 30 ml/min (estimated from creatinine, age and sex at the inclusion visit by the MDRD-formula)
  • 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.

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): NCT02092051


Locations
Sweden
Alingsås Hospital
Alingsås, Sweden, 44183
Angered Hospital
Angered, Sweden, 42422
Helsingborg Hospital
Helsingborg, Sweden, 25187
Öbackakliniken
Härnösand, Sweden, 871 82
Centralhospital Kristianstad
Kristianstad, Sweden, 29185
Halland's Hospital Kungsbacka
Kungsbacka, Sweden, 43480
Malmö University Hospital
Malmö, Sweden, 205 02
Motala Hospital
Motala, Sweden, 591 85
Vrinnevisjukhuset
Norrköping, Sweden, 603 82
Södersjukhuset
Stockholm, Sweden, 118 81
Trelleborg Hospital
Trelleborg, Sweden, 231 85
Uddevalla Hospital
Uddevalla, Sweden, 45180
Academic Hospital Uppsala
Uppsala, Sweden, 75185
Ängelholm Hospital
Ängelholm, Sweden, 262 81
University Hospital Örebro
Örebro, Sweden, 70185
Sponsors and Collaborators
Vastra Gotaland Region
DexCom, Inc.
Investigators
Principal Investigator: Marcus Lind, MD, PhD NU-Hospital Organization

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02092051     History of Changes
Other Study ID Numbers: CGMMDI
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: November 2016

Keywords provided by Vastra Gotaland Region:
Continuous glucose monitoring
Type 1 diabetes
Insulin injections
Cross-over

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs