Analysis of a messaging service to support patients with type 2 diabetes on basal insulin therapy

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN11911344
• Lead Sponsor: Roche Diabetes Care GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-14
• Study Completion: 2022-02-23
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Signed written informed consent
2. Male and female patients with at least 21 years of age
3. Diabetes mellitus type 2
4. Initiation of BOT planned including training in diabetes mellitus, BOT therapy, FBG measurement and basal insulin administration
5. Individual FBG target range set to 140 mg/dL (7.8 mmol/l) or lower by the investigator as described by BOT guidelines
6. HbA1c =7.5% (58,5 mmol/mol), determined within the previous 3 months
7. Possessing and using a mobile phone including SMS messaging and having access to the mobile phone network while at home (self-assessed)
8. Ability and willingness to participate in the study, to read and understand all study materials (subject information, informed consent and data protection form, IFU, SMS text messages, questionnaires) and to comply with study procedures, including daily BG measurement with the Accu-Chek® BG meter handed out for the study and administration of once-daily, long-acting insulin as well as timely sending and receiving SMS text messages in the morning and in the evening and blood draws for repeated HbA1c determination

Exclusion Criteria

1. Prior insulin therapy except for gestational diabetes or for < 1 week
2. Current insulin therapy, e.g. prandial insulin, premixed insulin
3. Known impaired awareness of hypoglycemia with current history of regular hypoglycemia or hospitalization(s) because of severe hypoglycemia in the previous 3 months
4. Significant manifestation of severe diabetes-related long-term complications e.g. severe retinopathy, neuropathy, nephropathy requiring dialysis
5. Pregnant or planning to become pregnant or breastfeeding
6. Legal incompetence or limited legal competence
7. Serious or unstable chronic physical or psychological condition rendering the subject unable to understand the nature and the scope of the study and to follow the study procedures
8. Addiction to alcohol or other substance(s) of abuse as assessed by the investigator
9. Dependency on sponsor or Investigator (e.g. co-worker or family member)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of subjects with FBG stable in their individual target range after completion of GetFit supported basal insulin titration at latest, measured using [method] calculated using system data at Visit 4 (week 16 [±14 days])