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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sensor Based Glucose Monitoring System
Standard Blood Glucose Monitoring
Sponsored by
Abbott Diabetes Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Sensing Technology, Type 1 Diabetes,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
  • Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel
  • Medizinische Universität Innsbruck
  • Diakonissen-Krankenhaus Salzburg
  • Klinik fuer Innere Medizin III Medizinische Universitaet Wien
  • Wilhelminenspital Medzin 5
  • Diabetes Klinik Bad Mergentheim
  • Zentrum für Diabetologie Hamburg Bergedorf
  • Diabetes-Zentrum Hannover-Nord
  • Diabetes Center Quakenbruck
  • Versdias GmbH
  • Vrije Universiteit Medisch Centrum
  • Onze Lieve Vrouwe gasthuis ( OLVG)
  • Amphia Ziekenhuis
  • Medisch Centrum Haaglanden
  • Bethesda Diabetes Research Center
  • St. Antonius Ziekenhuis
  • Hospital Germans Trias i Pujol
  • Clinica Diabetologica
  • Servicio de Endocrinología Hospital Unversitario Cruces
  • Falu Lasarett
  • Karolinska Universitetssjukhuset Solna
  • Karolinska Universitetssjukhuset Huddinge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sensor Based Glucose Monitoring System

Standard Blood Glucose Monitoring

Arm Description

Standard sensing system use for 6 months.

Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Outcomes

Primary Outcome Measures

Time Spent <70 mg/dL
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

HbA1c at 6 Months
Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1
Time Spent <55 mg/dL and <40 mg/dL
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).
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
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).
Time Spent >180 mg/dL and >240 mg/dL
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).
Time in Range
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).
Number of Glucose Measurements Performed
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.
System Utilisation
System utilisation assessed by percentage of sensor glucose data collected by the intervention group
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to 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).

Full Information

First Posted
September 3, 2014
Last Updated
February 27, 2017
Sponsor
Abbott Diabetes Care
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1. Study Identification

Unique Protocol Identification Number
NCT02232698
Brief Title
An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)
Acronym
IMPACT
Official Title
Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Diabetes Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Sensing Technology, Type 1 Diabetes,

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensor Based Glucose Monitoring System
Arm Type
Experimental
Arm Description
Standard sensing system use for 6 months.
Arm Title
Standard Blood Glucose Monitoring
Arm Type
Active Comparator
Arm Description
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
Intervention Type
Device
Intervention Name(s)
Sensor Based Glucose Monitoring System
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Standard Blood Glucose Monitoring
Intervention Description
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).
Primary Outcome Measure Information:
Title
Time Spent <70 mg/dL
Description
Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Time Frame
Baseline and Days 194 to 208
Secondary Outcome Measure Information:
Title
HbA1c at 6 Months
Description
Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1
Time Frame
Baseline and Day 208
Title
Time Spent <55 mg/dL and <40 mg/dL
Description
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).
Time Frame
Baseline and Days 194 to 208
Title
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
Description
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).
Time Frame
Baseline and Days 194-208
Title
Time Spent >180 mg/dL and >240 mg/dL
Description
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).
Time Frame
Baseline and Days 194 to 208
Title
Time in Range
Description
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).
Time Frame
Baseline and Days 194 to 208
Title
Number of Glucose Measurements Performed
Description
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.
Time Frame
Days 1 to 208
Title
System Utilisation
Description
System utilisation assessed by percentage of sensor glucose data collected by the intervention group
Time Frame
Days 15 to 208
Title
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208
Description
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).
Time Frame
Baseline and Day 208

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Type 1 diabetes for ≥ 5 years On their current insulin regimen for ≥ 3 months prior to study entry Screening HbA1c result ≤ 7.5% (58 mmol/mol) 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 In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System Aged 18 years or over. Exclusion Criteria: 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) Subject is currently prescribed animal insulin Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study Has known allergy to medical grade adhesives Currently participating in another device or drug study that could affect glucose measurements or glucose management Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months Currently using Sensor augmented pump therapy Is planning to use a CGM device at any time during the study A female subject who is pregnant or planning to become pregnant within the study duration A breast feeding mother Currently receiving dialysis treatment or planning to receive dialysis during the study Has a pacemaker Has experienced an acute myocardial infarction within previous 6 months 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 Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Matthaei
Organizational Affiliation
Diabetes Center Quakenbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Diakonissen-Krankenhaus Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Klinik fuer Innere Medizin III Medizinische Universitaet Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminenspital Medzin 5
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Diabetes Klinik Bad Mergentheim
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Facility Name
Zentrum für Diabetologie Hamburg Bergedorf
City
Hamburg
ZIP/Postal Code
21029
Country
Germany
Facility Name
Diabetes-Zentrum Hannover-Nord
City
Hannover
ZIP/Postal Code
30165
Country
Germany
Facility Name
Diabetes Center Quakenbruck
City
Quakenbrück
ZIP/Postal Code
49610
Country
Germany
Facility Name
Versdias GmbH
City
Sūlzbach-Rosenberg
ZIP/Postal Code
92237
Country
Germany
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
Onze Lieve Vrouwe gasthuis ( OLVG)
City
Amsterdam
ZIP/Postal Code
1090 HM
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4800 RK
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Name
Bethesda Diabetes Research Center
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Utrecht
ZIP/Postal Code
3543 AZ
Country
Netherlands
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Clinica Diabetologica
City
Gijon
ZIP/Postal Code
33206
Country
Spain
Facility Name
Servicio de Endocrinología Hospital Unversitario Cruces
City
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
SE-791 29
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna
City
Solna
ZIP/Postal Code
SE-171 76
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29273897
Citation
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.
Results Reference
derived
PubMed Identifier
28945936
Citation
Rayman G, Kroger 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.
Results Reference
derived
PubMed Identifier
27634581
Citation
Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger 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.
Results Reference
derived

Learn more about this trial

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

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