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Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes

Informatics-Based Digital Intervention to Promote Safe Exercise in Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes - A Pilot Efficacy Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study will develop a phone app to help adults ages 30–65 with type 1 diabetes or other diabetes with too little insulin exercise more often and feel more confident. The app will give personal encouragement and tips based on blood sugar, exercise, mood, and sleep. The study is done remotely, with no required in-person visits.

The challenges of living with type 1 diabetes often stand in the way of getting enough exercise. Continuous blood sugar monitoring has revolutionized type 1 diabetes care but remains underutilized to sustainably support exercise and related behaviors. This remote participation-based research will develop a mobile application that delivers personalized encouragement and data-driven health insights based upon patterns in blood sugar, exercise, mood, and sleep, to assist people with type 1 diabetes in exercising more frequently and confidently. You do not need to live in Connecticut to participate, as there will be no required in-person visits during the study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 30–65 years old.
  • Have type 1 diabetes or another type with too little insulin, such as adult-onset autoimmune diabetes or diabetes caused by swelling of the pancreas.
  • Exercise less than once a week.
  • Own a smartphone and have home wireless broadband internet or cell service.
  • Can read English.
  • See a healthcare provider at least once a year.
  • Use a continuous glucose monitor, which tracks blood sugar, and have shared its data with your medical record for at least 6 weeks.
  • Use an insulin pump or pen and have shared its data with your medical record for at least 6 weeks.

Who can't join

  • In the past 6 months, had diabetic ketoacidosis—a dangerous acid buildup—not clearly caused by a pump site failure, or had more than one low-blood-sugar episode that required another person's help.
  • Have an A1c of 10% or higher, a measure of average blood sugar, or resting blood pressure with a top number over 160 or bottom number over 100.
  • Had a heart attack or angina (heart-related chest pain) in the past 12 months, have an uncontrolled abnormal heartbeat, or have stage 3 or 4 heart failure.
  • Have asthma triggered by exercise that inhalers do not control, or chronic obstructive pulmonary disease (COPD), a lung disease, that requires home oxygen.
  • Have kidney failure or are pregnant.
  • Have problems with thinking or memory.
  • Have severe damage to the eyes' light-sensing tissue or severe nerve damage.
  • Have another long-term illness or physical disability that would affect the exercise program, such as recent spine surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: * 30-65 years old inclusive * Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis) * Less than 1.0 exercise sessions per week * Smartphone ownership * English literacy * Under regular care by a healthcare provider (1+ appointments per year) * Home Broadband wireless Internet or cell phone network * Using continuous glucose monitor (CGM) and sharing data with medical record for at least 6 weeks * Using insulin pump or pen and sharing data with medical record for at least 6 weeks Exclusion criteria: * Diabetic ketoacidosis not clearly related to pump site failure in past 6 months * \>1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months * A1c ≥10.0% * Resting blood pressure \>160mmHg systolic or \>100 mmHg diastolic. * Myocardial infarction or angina in past 12 months * Uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response, new onset atrial fibrillation, ventricular tachycardia, escape rhythms) * Congestive heart failure (stage 3 or 4) * Exercise-induced asthma (not controlled on inhalers) * Chronic obstructive pulmonary disease (requiring home oxygen) * Renal failure * Pregnancy * Cognitive impairment * Severe retinopathy or neuropathy. * Other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)

Study sites (1)

CT