N/A
Completed N=122
ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02600845 ↗
Enrolled (actual)
122
Serious AEs
6.6%
Results posted
Nov 2017
Primary outcomePrimary: Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24 — 14.3 score on a scale
Summary
This post-market, interventional, prospective, single arm, the United States (US) based multi-center study will assess the change in treatment satisfaction of participants who utilize the ACCU-CHEK Connect Diabetes Management System over a period of 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24 |
14.3 | — |
| SECONDARY Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score |
-0.3 | — |
| SECONDARY Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 |
-1.07; -0.95 | — |
| SECONDARY Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range |
14.74 | — |
| SECONDARY Change From Baseline to Week 24 in Mean Blood Glucose Level |
-24.79 | — |
| SECONDARY Change From Baseline to Week 24 in Glycemic Variability |
-9.26 | — |
| SECONDARY Incidence of Hypoglycemia |
1.45; 1.08; 1.48 | — |
| SECONDARY Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24 |
1 | — |
| SECONDARY Percent of Follow-Up Visits With Sufficient SMBG Data |
91.71 | — |
| SECONDARY Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24 |
16.25; 9.37 | — |
| SECONDARY Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at Weeks 12 and 24 |
0.45; 0.22 | — |
| SECONDARY Percentage of Blood Glucose Tagged Data |
84.24; 86.87 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 1 or type 2 diabetes for greater than or equal to (>=) 6 months
- Currently using insulin as a component of the diabetes therapy
- Allow and be able to provide self-monitoring of blood glucose (SMBG) data at least 1 month prior to study start
- SMBG frequency as confirmed by site SMBG data download of participants meter(s): Basal insulin treated participants - SMBG >=5 times per week and Multiple dose insulin participants - SMBG >=2 times per day
- Glycosylated hemoglobin (HbA1c) of >=7.5 percentage (per local laboratory obtained less than or equal to [<= 3] months of Baseline)
- Able to read and write in English language
- Currently using a Smartphone and have experience with downloading at minimum one application
- Smartphone compatibility; must be able to download the ACCU-CHEK Connect system application accordingly
- Naive to the ACCU-CHEK Connect system
- Willing to comply with study procedures
Exclusion Criteria
- Treatment with insulin pump therapy
- Any use of continuous glucose monitoring (CGM) to manage their diabetes during the course of the study
- Visually impaired
- Women who are pregnant, lactating or planning to become pregnant during the study period
- Diagnosed with any clinically significant condition (for example anemia, major organ system disease, infections, psychosis or cognitive impairment)
- Participant requires chronic steroid in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
- Participant is the investigator or any sub-investigator, general practitioner, practice staff, pharmacist, research assistant or other staff or relative of those directly involved in the conduct of the study and design of the protocol
Data sourced from ClinicalTrials.gov (NCT02600845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.