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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: Sensor Based Glucose Monitoring System; Device: Standard Blood Glucose Monitoring

• Registration Number: NCT02232698
• Lead Sponsor: Abbott Diabetes Care

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-05
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2017-01-06
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Results First Posted: 2017-04-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sensor Based Glucose Monitoring System	Sensor Based Glucose Monitoring System	Standard sensing system use for 6 months.
Standard Blood Glucose Monitoring	Standard Blood Glucose Monitoring	Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.

Primary Outcome Measures

Name	Time	Method
Time Spent <70 mg/dL	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

Name	Time	Method
HbA1c at 6 Months	Baseline and Day 208	Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1
Time in Range	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).
Number of Glucose Measurements Performed	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.
Time Spent <55 mg/dL and <40 mg/dL	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).
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208	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).
Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL	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).
Time Spent >180 mg/dL and >240 mg/dL	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).
System Utilisation	Days 15 to 208	System utilisation assessed by percentage of sensor glucose data collected by the intervention group

Trial Locations

Locations (23)

Klinik fuer Innere Medizin III Medizinische Universitaet Wien; 🇦🇹 Wien, Austria

VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie; 🇦🇹 Feldkirch, Austria

Bethesda Diabetes Research Center; 🇳🇱 Hoogeveen, Netherlands

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Clinica Diabetologica; 🇪🇸 Gijon, Spain

Diabetes Klinik Bad Mergentheim; 🇩🇪 Bad Mergentheim, Germany

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Wilhelminenspital Medzin 5; 🇦🇹 Wien, Austria

Diabetes Center Quakenbruck; 🇩🇪 Quakenbrück, Germany

Medisch Centrum Haaglanden; 🇳🇱 Den Haag, Netherlands

Karolinska Universitetssjukhuset Solna; 🇸🇪 Solna, Sweden

Zentrum für Diabetologie Hamburg Bergedorf; 🇩🇪 Hamburg, Germany

Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel; 🇦🇹 Graz, Austria

Onze Lieve Vrouwe gasthuis ( OLVG); 🇳🇱 Amsterdam, Netherlands

Falu Lasarett; 🇸🇪 Falun, Sweden

Diabetes-Zentrum Hannover-Nord; 🇩🇪 Hannover, Germany

Diakonissen-Krankenhaus Salzburg; 🇦🇹 Salzburg, Austria

Versdias GmbH; 🇩🇪 Sūlzbach-Rosenberg, Germany

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Utrecht, Netherlands

Servicio de Endocrinología Hospital Unversitario Cruces; 🇪🇸 Vizcaya, Spain

Karolinska Universitetssjukhuset Huddinge; 🇸🇪 Stockholm, Sweden

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria