An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT) (IMPACT)

Study Description

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Brief Summary:

The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes Mellitus	Device: Sensor Based Glucose Monitoring System; Device: Standard Blood Glucose Monitoring	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	328 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes
Study Start Date :	September 2014
Actual Primary Completion Date :	October 2015
Actual Study Completion Date :	October 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Sensor Based Glucose Monitoring System; Standard sensing system use for 6 months.	Device: Sensor Based Glucose Monitoring System; Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
Active Comparator: Standard Blood Glucose Monitoring; Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.	Device: Standard Blood Glucose Monitoring; Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).

Outcome Measures

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Primary Outcome Measures :

1. Time Spent <70 mg/dL [ Time Frame: Baseline and Days 194 to 208 ]
   Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).

Secondary Outcome Measures :

1. HbA1c at 6 Months [ Time Frame: Baseline and Day 208 ]
   Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1
2. Time Spent <55 mg/dL and <40 mg/dL [ Time Frame: Baseline and Days 194 to 208 ]
   Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
3. Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL [ Time Frame: Baseline and Days 194-208 ]
   Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
4. Time Spent >180 mg/dL and >240 mg/dL [ Time Frame: Baseline and Days 194 to 208 ]
   Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
5. Time in Range [ Time Frame: Baseline and Days 194 to 208 ]
   Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).
6. Number of Glucose Measurements Performed [ Time Frame: Days 1 to 208 ]
   Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.
7. System Utilisation [ Time Frame: Days 15 to 208 ]
   System utilisation assessed by percentage of sensor glucose data collected by the intervention group
8. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 [ Time Frame: Baseline and Day 208 ]

   The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).

   There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).

   The ANCOVA adjusts for baseline DTSQs (status version).

Eligibility Criteria

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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:

1. Diagnosed with Type 1 diabetes for ≥ 5 years
2. On their current insulin regimen for ≥ 3 months prior to study entry
3. Screening HbA1c result ≤ 7.5% (58 mmol/mol)
4. Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry
5. In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
6. Aged 18 years or over.

Exclusion Criteria:

1. Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia)
2. Subject is currently prescribed animal insulin
3. Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
4. Has known allergy to medical grade adhesives
5. Currently participating in another device or drug study that could affect glucose measurements or glucose management
6. Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
7. Currently using Sensor augmented pump therapy
8. Is planning to use a CGM device at any time during the study
9. A female subject who is pregnant or planning to become pregnant within the study duration
10. A breast feeding mother
11. Currently receiving dialysis treatment or planning to receive dialysis during the study
12. Has a pacemaker
13. Has experienced an acute myocardial infarction within previous 6 months
14. Has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition
15. Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
16. In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.

Contacts and Locations

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Locations

Austria
VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
Feldkirch, Austria, 6807
Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel
Graz, Austria, 8036
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Diakonissen-Krankenhaus Salzburg
Salzburg, Austria, 5020
Klinik fuer Innere Medizin III Medizinische Universitaet Wien
Wien, Austria, 1090
Wilhelminenspital Medzin 5
Wien, Austria, 1160
Germany
Diabetes Klinik Bad Mergentheim
Bad Mergentheim, Germany, 97980
Zentrum für Diabetologie Hamburg Bergedorf
Hamburg, Germany, 21029
Diabetes-Zentrum Hannover-Nord
Hannover, Germany, 30165
Diabetes Center Quakenbruck
Quakenbrück, Germany, 49610
Versdias GmbH
Sūlzbach-Rosenberg, Germany, 92237
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1007 MB
Onze Lieve Vrouwe gasthuis ( OLVG)
Amsterdam, Netherlands, 1090 HM
Amphia Ziekenhuis
Breda, Netherlands, 4800 RK
Medisch Centrum Haaglanden
Den Haag, Netherlands, 2512 VA
Bethesda Diabetes Research Center
Hoogeveen, Netherlands, 7909 AA
St. Antonius Ziekenhuis
Utrecht, Netherlands, 3543 AZ
Spain
Hospital Germans Trias i Pujol
Badalona, Spain, 8916
Clinica Diabetologica
Gijon, Spain, 33206
Servicio de Endocrinología Hospital Unversitario Cruces
Vizcaya, Spain, 48903
Sweden
Falu Lasarett
Falun, Sweden, SE-791 29
Karolinska Universitetssjukhuset Solna
Solna, Sweden, SE-171 76
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, SE-141 86

Sponsors and Collaborators

Abbott Diabetes Care

Investigators

Principal Investigator:	Stephan Matthaei	Diabetes Center Quakenbruck

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018 Mar;61(3):539-550. doi: 10.1007/s00125-017-4527-5. Epub 2017 Dec 23.

Rayman G, Kröger J, Bolinder J. Could FreeStyle Libre(™) sensor glucose data support decisions for safe driving? Diabet Med. 2018 Apr;35(4):491-494. doi: 10.1111/dme.13515. Epub 2017 Oct 14.

Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.

Responsible Party:	Abbott Diabetes Care
ClinicalTrials.gov Identifier:	NCT02232698 History of Changes
Other Study ID Numbers:	ADC-CI-APO-13019
First Posted:	September 5, 2014
Results First Posted:	April 10, 2017
Last Update Posted:	April 10, 2017
Last Verified:	February 2017

Keywords provided by Abbott Diabetes Care:

Sensing Technology; Type 1 Diabetes,

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Glucose Metabolism Disorders	Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases